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Interventions for preventing weight gain after smoking cessation
Abstract
Background:
Most people who stop smoking gain weight. This can discourage some people from making a quit attempt and risks offsetting some, but not all, of the health advantages of quitting. Interventions to prevent weight gain could improve health outcomes, but there is a concern that they may undermine quitting.
Objectives:
To systematically review the effects of: (1) interventions targeting post-cessation weight gain on weight change and smoking cessation (referred to as 'Part 1') and (2) interventions designed to aid smoking cessation that plausibly affect post-cessation weight gain (referred to as 'Part 2').
Search methods:
Part 1 - We searched the Cochrane Tobacco Addiction Group's Specialized Register and CENTRAL; latest search 16 October 2020. Part 2 - We searched included studies in the following 'parent' Cochrane reviews: nicotine replacement therapy (NRT), antidepressants, nicotine receptor partial agonists, e-cigarettes, and exercise interventions for smoking cessation published in Issue 10, 2020 of the Cochrane Library. We updated register searches for the review of nicotine receptor partial agonists.
Selection criteria:
Part 1 - trials of interventions that targeted post-cessation weight gain and had measured weight at any follow-up point or smoking cessation, or both, six or more months after quit day. Part 2 - trials included in the selected parent Cochrane reviews reporting weight change at any time point.
Data collection and analysis:
Screening and data extraction followed standard Cochrane methods. Change in weight was expressed as difference in weight change from baseline to follow-up between trial arms and was reported only in people abstinent from smoking. Abstinence from smoking was expressed as a risk ratio (RR). Where appropriate, we performed meta-analysis using the inverse variance method for weight, and Mantel-Haenszel method for smoking.
Main results:
Part 1: We include 37 completed studies; 21 are new to this update. We judged five studies to be at low risk of bias, 17 to be at unclear risk and the remainder at high risk. An intermittent very low calorie diet (VLCD) comprising full meal replacement provided free of charge and accompanied by intensive dietitian support significantly reduced weight gain at end of treatment compared with education on how to avoid weight gain (mean difference (MD) -3.70 kg, 95% confidence interval (CI) -4.82 to -2.58; 1 study, 121 participants), but there was no evidence of benefit at 12 months (MD -1.30 kg, 95% CI -3.49 to 0.89; 1 study, 62 participants). The VLCD increased the chances of abstinence at 12 months (RR 1.73, 95% CI 1.10 to 2.73; 1 study, 287 participants). However, a second study found that no-one completed the VLCD intervention or achieved abstinence. Interventions aimed at increasing acceptance of weight gain reported mixed effects at end of treatment, 6 months and 12 months with confidence intervals including both increases and decreases in weight gain compared with no advice or health education. Due to high heterogeneity, we did not combine the data. These interventions increased quit rates at 6 months (RR 1.42, 95% CI 1.03 to 1.96; 4 studies, 619 participants; I2 = 21%), but there was no evidence at 12 months (RR 1.25, 95% CI 0.76 to 2.06; 2 studies, 496 participants; I2 = 26%). Some pharmacological interventions tested for limiting post-cessation weight gain (PCWG) reduced weight gain at the end of treatment (dexfenfluramine, phenylpropanolamine, naltrexone). The effects of ephedrine and caffeine combined, lorcaserin, and chromium were too imprecise to give useful estimates of treatment effects. There was very low-certainty evidence that personalized weight management support reduced weight gain at end of treatment (MD -1.11 kg, 95% CI -1.93 to -0.29; 3 studies, 121 participants; I2 = 0%), but no evidence in the longer-term 12 months (MD -0.44 kg, 95% CI -2.34 to 1.46; 4 studies, 530 participants; I2 = 41%). There was low to very low-certainty evidence that detailed weight management education without personalized assessment, planning and feedback did not reduce weight gain and may have reduced smoking cessation rates (12 months: MD -0.21 kg, 95% CI -2.28 to 1.86; 2 studies, 61 participants; I2 = 0%; RR for smoking cessation 0.66, 95% CI 0.48 to 0.90; 2 studies, 522 participants; I2 = 0%). Part 2: We include 83 completed studies, 27 of which are new to this update. There was low certainty that exercise interventions led to minimal or no weight reduction compared with standard care at end of treatment (MD -0.25 kg, 95% CI -0.78 to 0.29; 4 studies, 404 participants; I2 = 0%). However, weight was reduced at 12 months (MD -2.07 kg, 95% CI -3.78 to -0.36; 3 studies, 182 participants; I2 = 0%). Both bupropion and fluoxetine limited weight gain at end of treatment (bupropion MD -1.01 kg, 95% CI -1.35 to -0.67; 10 studies, 1098 participants; I2 = 3%); (fluoxetine MD -1.01 kg, 95% CI -1.49 to -0.53; 2 studies, 144 participants; I2 = 38%; low- and very low-certainty evidence, respectively). There was no evidence of benefit at 12 months for bupropion, but estimates were imprecise (bupropion MD -0.26 kg, 95% CI -1.31 to 0.78; 7 studies, 471 participants; I2 = 0%). No studies of fluoxetine provided data at 12 months. There was moderate-certainty that NRT reduced weight at end of treatment (MD -0.52 kg, 95% CI -0.99 to -0.05; 21 studies, 2784 participants; I2 = 81%) and moderate-certainty that the effect may be similar at 12 months (MD -0.37 kg, 95% CI -0.86 to 0.11; 17 studies, 1463 participants; I2 = 0%), although the estimates are too imprecise to assess long-term benefit. There was mixed evidence of the effect of varenicline on weight, with high-certainty evidence that weight change was very modestly lower at the end of treatment (MD -0.23 kg, 95% CI -0.53 to 0.06; 14 studies, 2566 participants; I2 = 32%); a low-certainty estimate gave an imprecise estimate of higher weight at 12 months (MD 1.05 kg, 95% CI -0.58 to 2.69; 3 studies, 237 participants; I2 = 0%).
Authors' conclusions:
Overall, there is no intervention for which there is moderate certainty of a clinically useful effect on long-term weight gain. There is also no moderate- or high-certainty evidence that interventions designed to limit weight gain reduce the chances of people achieving abstinence from smoking.
... Behavioural support interventions offer advice and counselling that focuses on stopping smoking and/ or providing information about stopping smoking, either in a group or one-to-one setting (Hartmann-Boyce et al, 2021). Telephone counselling, quit lines and, more recently, mobile phone apps are used to support those who are considering quitting, and those who have recently quit smoking (Crane et al, 2018;NICE, 2018). ...
... Telephone counselling, quit lines and, more recently, mobile phone apps are used to support those who are considering quitting, and those who have recently quit smoking (Crane et al, 2018;NICE, 2018). Behaviour support interventions can independently increase quit rates with the strongest benefits found when using any form of counselling (Hartmann-Boyce et al, 2021). ...
... Therefore, more high-quality trials are required in this area to better understand the role of mindfulness techniques in smoking cessation. There is insufficient evidence to suggest a possible beneficial role of smoking cessation and weight gain therapies in limiting post-cessation weight gain in people stopping smoking in the long term (Hartmann-Boyce et al, 2021) and also of exercise interventions aiming to increase cessation rates among smokers (Ussher et al, 2019). ...
Despite a general decline in smoking in the UK, prevalence remains high in certain groups such as young adults, pregnant women, those who have a mental Illness and those from socio-economically disadvantaged backgrounds. These groups are also more likely to benefit from targeted smoking cessation interventions. Clinical contact between health professionals and patients who smoke creates an opportunity for offering cessation interventions and to reduce smoking-related harm. This article summarises evidence reported in high-quality systematic reviews on smoking cessation interventions that could be offered by health professionals coming in to contact with patients who smoke. The evidence presented here suggests that brief advice by a health professional is beneficial in achieving smoking cessation and so is intensive behavioural support, alone or in combination with pharmacotherapies (nicotine replacement therapies [NRTs], bupropion and varenicline). Pharmacotherapies are also effective individually in achieving smoking cessation; a combination of NRTs (oral or skin patch) can be particularly helpful among highly dependent smokers. Pharmacotherapies in combination with behavioural support delivered in healthcare settings are more effective than when used alone and delivered in community settings, respectively. Electronic cigarettes are also effective in achieving smoking cessation and are more effective than NRT.
... This interpretation is supported by the finding that among both persons of migrant origin and the general population, respondents with a high body mass index (bMI) were less likely to increase their smoking than those who were underweight/normal weight. People who stop smoking might gain some weight, which might discourage some smokers from attempting to quit [28]. using nicotine replacement therapy (nRT) might reduce weight after smoking cessation, although the long-term effects are inconclusive [28]. ...
... People who stop smoking might gain some weight, which might discourage some smokers from attempting to quit [28]. using nicotine replacement therapy (nRT) might reduce weight after smoking cessation, although the long-term effects are inconclusive [28]. based on this notion, persons of migrant origin with a bMI of at least 30 might benefit from using nRT in their attempts to quit. ...
Aims: Prior studies have implied that smokers may have changed their smoking behaviour during the COVID-19 pandemic. However, little is known about changes in smoking behaviour and correlates of change due to the pandemic among persons of migrant origin compared with the general population.
Methods: Population-based cross-sectional studies with comparable study protocols and measures, one focusing on persons of migrant origin living in Finland (n = 3587, response rate 60%) and the other on the general Finnish population (n = 3444, response rate 56%), were utilised. The outcome measure was self-reported change in smoking behaviour due to COVID-19 among current smokers. Explanatory factors included sociodemographic-, health-, and COVID-19-related factors. Multinomial logistic regression was used in the analyses.
Results: Most of the current smokers reported no change in their smoking behaviour. In the adjusted model, younger age was positively associated with increased smoking, while region of origin (Russia, Africa, Asia, and Latin America) and worrying about getting infected with COVID-19 were associated with decreased smoking among persons of migrant origin. In the general population, younger age, female sex, being other than employed/student, increased loneliness, and decreased contact with close ones were associated with increased smoking, while reduced working capacity and worries that someone close to the respondent will be infected with COVID-19 were associated with decreased smoking.
Conclusions: The findings of this study contribute to better identification of at-risk populations in future crises situations. This will allow for more efficient targeting and tailoring of health promotion services, including smoking cessation.
... 10,11 It is well known that smokers who make a serious attempt to quit smoking with pharmacological therapy gain less weight in the process. 12 Perhaps, those who gain weight and therefore do not attend the follow-ups visits do not follow the pharmacological treatments, nor do they follow the dietary advice or not are subjected to strict control of their weight evolution throughout the smoking cessation process. [12][13][14] Regarding the beliefs of why smokers believe that they are not capable of quitting, they have been indicated, addiction, habit, willpower and motivation, as causes of the inability to stop smoking. ...
... 12 Perhaps, those who gain weight and therefore do not attend the follow-ups visits do not follow the pharmacological treatments, nor do they follow the dietary advice or not are subjected to strict control of their weight evolution throughout the smoking cessation process. [12][13][14] Regarding the beliefs of why smokers believe that they are not capable of quitting, they have been indicated, addiction, habit, willpower and motivation, as causes of the inability to stop smoking. 10 The present work has several limitations: 1. ...
... Additionally, a meta-analysis of the effectiveness of multiple risk behavior interventions suggested that there is a concern that targeting both health outcomes may undermine quitting (Meader et al., 2017). An update of Farley et al. (2012) meta-analysis, current up to October 2020(Hartmann-Boyce et al., 2021, concluded that it is not clear which treatments work best to avoid gaining weight when stopping smoking, or how they affect smoking abstinence outcomes. Implications for research of this meta-analysis stressed that behavioral programmes are the mainstay for weight management and further studies are needed to clarify the evidence on whether they limit weight gain and impact on smoking abstinence (e.g., it was found that a personalized weight-management programme may reduce weight gain but a weight-management programme without personalized assessment, planning and feedback may not reduce weight gain, and may reduce the number of people who stop smoking). ...
... In line with previous meta-analysis Hartmann-Boyce et al., 2021;Spring et al., 2009) but in contrast with others (Meader et al., 2017) concluding that it may not be optimal to target smoking simultaneously with other risk behaviors, the present study found that there was no evidence to suggest that adding a weight management component worsened smoking cessation outcomes. In fact, it seems that adding a weight component to a smoking cessation intervention improves smoking cessation outcomes at EOT, but that such effect is short lived, and likely an artifact of increasing the intensity or attention provided to the individuals in treatment. ...
I ntroduction
The potential of weight gain after smoking cessation reduces the incentive to quit. This meta-analysis examines the efficacy of behavioral interventions for smoking cessation that also address post-cessation weight gain.
Methods
Medline, Web of Science, PsycINFO and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials on behavioral treatments targeting both health outcomes. Six separate meta-analyses were undertaken to assess treatment efficacy on smoking abstinence and weight outcomes at end of treatment (EOT), short-term, and long-term follow-up. Individual and treatment moderators were examined as well as methodological quality and publication bias of studies.
Results
A total of 28 studies were included in the meta-analysis. There was a statistically significant positive impact of treatments addressing both targets on smoking outcomes at EOT (RR = 1.279, 95% CI: 1.096, 1.492, p = .002), but not at follow-ups. Age impacted on EOT abstinence rates Q (1) = 4.960, p = .026) while increasing the number of sessions significantly improved EOT abstinence rates (p = .020). There was no statistically significant impact of these treatments on weight at EOT (Hedges’ g = -.015, 95% CI: -.164, .135, p = .849) or follow-ups (short term: Hedges’ g = .055, 95% CI: -.060, .170, p = .347; long term: Hedges’ g = -.320, 95% CI: -.965, .325, p = .331). There were minimal impacts of publication bias, mostly related to sample size, meaning studies including small sample sizes revealed larger effect sizes on abstinence at EOT.
Discussion
Addressing post-cessation weight management in treatments for smoking cessation significantly enhances tobacco abstinence at EOT though it was not found to have a lasting impact after treatment.
... Furthermore, longer courses of NRT were not associated with reduced weight gain at 12 months and there was no significant dose dependent difference in weight gain at the end of treatment or at 12 months [148]. The cited review was updated recently and concluded that there was moderate-certainty evidence that NRT reduced weight at the end of treatment and that the effect may be similar at 12 months [149]. Another network-meta-analysis reported that nicotine patches in combination with other medications, and especially fluoxetine, had superior efficacy in controlling PSCWG than placebo treatment, and that nicotine patch 14 mg plus fluoxetine 40 mg treatment might be one of the best options for patients with obesity and nicotine dependence. ...
... This report suggested that, of all three licensed medications, bupropion has the largest effect on weight gain. However, there is no strong evidence that bupropion reduces weight gain in the long-term [148,149]. Bupropion increases levels of dopamine and norepinephrine in the brain, similar to the effects of nicotine, providing a potential mechanism of weight control [9], decreases the nicotine-reward threshold and attenuates the effect of food reward [157]. Bupropion is safe for people with DM and, considering its ability to reduce PSCWG, it could therefore be proposed as a treatment of choice in obese patients with DM [101]. ...
Smokers with diabetes mellitus substantially lower their risks of microvascular and macrovascular diabetic complications, in particular cardiovascular disease, by quitting smoking. However, subsequent post-smoking-cessation weight gain may attenuate some of the beneficial effects of smoking cessation and discourage attempts to quit. Weight gain can temporarily exacerbate diabetes and deteriorate glycemic control and metabolic profile. The molecular mechanisms by which quitting smoking leads to weight gain are largely associated with the removal of nicotine’s effects on the central nervous system. This review addresses mechanisms of post-smoking-cessation weight gain, by reviewing the effects of nicotine on appetite, food intake, eating behaviour, energy expenditure, fat oxidation and appetite-regulating peptides. We also highlight correlations between post-cessation weight gain and risk of type 2 diabetes, consequences of weight gain in people with type 2 diabetes and the role of pharmacotherapies, which combine treatment of nicotine addiction and promotion of weight control.
... Exercise can help counteract weight gain and promote a healthier lifestyle, which can further support smoking cessation efforts. 16 In addition, regular exercise can help build self-efficacy, or the belief in one's ability to succeed in quitting smoking can support the maintenance of long-term abstinence. 17 Several forms of exercise have been evaluated as a complementary treatment for smoking cessation, including yoga, 18 aerobic exercise, 19 and resistance exercise. ...
This study examined a supervised moderate-intensity aerobic exercise programme’s effectiveness in regulating the Tobacco Withdrawal Symptoms (TWS) during temporary abstinence. This was a single group, pre and post-quasi intervention study. Thirty daily smokers participated in an 8-week supervised moderate-intensity aerobic exercise programme. We assessed the TWS, smoking urge, mood and stress-pleasure related hormonal variables after the aerobic exercise intervention. The measurements were conducted after overnight abstinence at baseline, post-intervention (at week-8) and post-detraining (at week-10). TWS components, smoking urge and mood were found to improve. For hormonal variables, cortisol and beta-endorphin except adrenaline showed insignificant changes at post-intervention and de-training. The findings suggest moderate-intensity exercise might help in reducing withdrawal symptoms and its adverse effects. Thus, exercise is an effective adjunct treatment in a smoking cessation programme.
... That is related to nicotine withdrawal that can lead to a decrease in metabolic rate and an increase anxiety levels, among other factors (Audrain-Mcgovern & Benowitz, 2011). A meta-analysis found that there is currently no intervention with a moderate level of certainty that effectively prevents long-term weight gain, nor is there evidence that weight gain prevention interventions improve smoking cessation rates (Hartmann-Boyce et al., 2021). Based on recent guideline, the recommended approach for treating obesity in smokers must prioritize smoking cessation as the primary focus. ...
Objectives
To evaluate the association between nutritional status in early adulthood and the burden of noncommunicable diseases (NCDs); To evaluate the influence of sociodemographic factors and lifestyle on the outcomes of BMI kg/m2 ≤24.9, ≥25.0, and ≥30.0; to estimate the population attributable fraction (PAF) to BMI elevated at 25 years old in the burden of NCDs in American adults.
Methods
We used data from 15 721 American adults participating in the National Health and Nutrition Examination Survey from 2007 to 2018. The Hazard Ratio (HR), Incidence Rate Ratio (IRR), and 95% confidence intervals (CI) were estimated in the proportional risk regression models of Cox (entire population) and Poisson (restricted to non-patients), respectively. The proportionality of the risk between the burden of NCDs and BMI at 25 years old was drawn by the Kaplan–Meier curve, and the PAF was calculated. All analyses were adjusted taking into account the sample weights.
Results
Health disparities (sex, age, race/ethnicity, education, poverty index, and education level), and lifestyle (physical activity, smoking, and alcohol consumption) influenced the current nutritional status. Cumulative survival in overweight and obese groups decreased considerably over time (p < .0001). Being overweight and obese in adulthood may increase the risk of early NCDs (HR: 1.68, 95% CI: 1.54–1.84 and HR: 2.87, 95% CI: 2.56–3.21, respectively). About 22.72% (95% CI: 19.99–25.36, p < .001) of the burden NCDs could have been avoided if overweight at age 25 had been prevented.
Conclusions
Monitoring weight change from young adulthood can provide a sensitive and useful clinical measure for early detection of adverse trends in NCDs risk.
... Specifically, the most recent Cochrane review indicates that while certain medications (e.g., phenylpropanolamine, naltrexone, dexfenfluramine, bupropion, fluoxetine) may be helpful in the short-term after quitting smoking, these medications are associated with potential side effects and seem to have limited efficacy in the long-term. 11 Similarly, there have also been multiple studies investigating behavioral intervention packages (e.g., exercise, diet modification, mindful eating, cognitive behavioral therapy) for reducing weight gain after quitting smoking. 12 However, meta-analysis has shown that these behavioral weight management intervention packages did not lead to a significant improvement in post-cessation weight gain. ...
Background
Smoking cessation is associated with weight gain, and the risk of weight gain is a common deterrent to quitting smoking. Thus, the identification of strategies for reducing post‐smoking cessation weight gain is critical.
Objective
Conduct secondary analysis of data from the Fit & Quit trial to determine if greater frequency of self‐weighing is associated with less weight gain in the context of smoking cessation.
Methods
Participants ( N = 305) were randomized to one of three 2‐month weight interventions (i.e., Stability, Loss, Bibliotherapy), followed by a smoking cessation intervention. Stability and Loss conditions received different types of self‐weighing feedback. All participants received e‐scales at baseline, to capture daily self‐weighing data over 12 months. General linear models were applied to test the main objective.
Results
Frequency of self‐weighing was (mean ± SD) 2.67 ± 1.84 days/week. The Stability condition had significantly higher self‐weighing frequency (3.18 ± 1.72 days/week) compared to the Loss (2.51 ± 1.99 days/week) and the Bibliotherapy conditions (2.22 ± 1.63 days/week). Adjusting for baseline weight and treatment condition, self‐weighing 3–4 days/week was associated with weight stability (−0.77 kg, 95% CI: −2.2946, 0.7474, p = 0.3175), and self‐weighing 5 or more days/week was associated with 2.26 kg weight loss (95% CI: −3.9249, −0.5953, p = 0.0080).
Conclusions
Self‐weighing may serve as a useful tool for weight gain prevention after smoking cessation. Feedback received about self‐weighing behaviors and weight trajectory (similar to the feedback Stability participants received) might enhance adherence.
... According to one systematic review and meta-analysis, individuals who received a variety of combined smoking and weight control treatments simultaneously were more likely to be abstinent from smoking and see reductions in weight, although effect sizes related to weight loss were small, and effects were no longer significant after six months [12]. A more recent review focused on post-cessation weight management studies [13] concluded, "there is no intervention for which there is moderate certainty of a clinically useful effect on longterm weight gain," although there was some indication that exercise interventions may reduce weight gain. Thus, there is a need to identify and test interventions that may preclude post-cessation weight gain and promote long-term cessation. ...
Background/Objectives
Weight gain is a barrier to smoking cessation. Previous interventions targeting weight gain while quitting smoking have largely been unsuccessful. The current study aimed to assess the efficacy of weight stability and weight loss interventions compared to a low-intensity, self-guided bibliotherapy weight management group.
Subjects/Methods
A randomized controlled trial with 12-month follow-up from 2018 to 2022 was conducted with participants (N = 305) who reported smoking at least five cigarettes per day for the last year and interest in quitting initially recruited from the Memphis, TN, USA area. Recruitment was expanded nationally with the onset of the COVID-19 pandemic. Subsequently, 276 completed 12-month follow-up.
Interventions/Methods
The Bibliotherapy group was provided a weight management book. Both the Stability and Loss groups met via telephone for eight weeks to learn strategies for maintaining/losing weight, respectively. All three groups then received the same six-week smoking cessation intervention, with six months of varenicline provided.
Results
Individuals in the Loss group lost more weight (−2.01 kg, SE = 1.58) than individuals in the Bibliotherapy group (+1.08 kg, SE = 1.49, p = 0.0004), while the Stability group (−0.30 kg, SE = 1.56) was not significantly different from the Bibliotherapy group (p = 0.17). Those in the Stability group did not gain a significant amount of weight. Participants in the Loss group did not gain back all weight lost after smoking cessation and ended the study approximately 2.01 kg lower than baseline. The Bibliotherapy group did not gain the amount of weight expected after cessation. There were no significant differences between groups related to self-reported smoking cessation at each time point except at eight-month follow-up (p = 0.005).
Conclusions and relevance
Results indicated the Stability and the Loss interventions were effective for preventing post-smoking cessation weight gain, with the Loss group having the benefit of sustained weight loss. These interventions may be helpful to implement to combat weight gain and potentially facilitate smoking cessation.
Trial Registration
The trial is registered on clinicaltrials.gov (NCT03156660).
... Therefore, participation in a physical exercise program is helpful in sustaining smoking abstinence. 5 Excessive alcohol use is also a trigger for smoking, and those who stop smoking are more likely to consume less alcohol than those who continue to smoke. 6 Hence, it is important to monitor alcohol use after cessation and intervene appropriately. ...
... Metanalysis concluded that pharmacological interventions limited the short-term weight gain during smoking cessation. However, there are no clinically effective interventions to restrict long-term weight gain currently (39). ...
Background
Smoking behavior differs between the sexes. Weight control is one of the main reasons leading to tobacco abuse in women but not in men. Studies on the predictive factors of cessation failure between sexes are scarce. This study is aim to investigate whether there are sex differences in the effect of weight gain on smoking cessation rate.
Methods
Participants in the smoking-cessation program at a Medical Center in Taiwan between 2018 and 2019 were included. Details of age, sex, comorbidities, depression screening, nicotine dependence, body weight, and cessation medications of the participants were collected. The participants were classified based on their sex, and multivariable logistic regression analyses were conducted. Multivariable logistic regression analyses were performed for sensitivity analysis after stratifying the participants according to their weight loss (weight loss ≥ 1.5 kg and weight loss ≥ 3.0 kg).
Results
A total of 1,475 participants were included. The body-weight gain in women was associated with failed abstinence (adjusted odds ratio (OR): 3.10, 95% CI: 1.10–9.04). In contrast, body-weight gain in men was associated with successful 6-month prolonged abstinence (adjusted OR: 0.77, 95% CI: 0.61–0.98). The adjusted ORs for any body-weight loss, body-weight loss ≥1.5 kg, and body-weight loss ≥3.0 kg were 0.28 (95% CI: 0.09–0.88), 0.14 (95% CI: 0.03–0.55), and 0.03 (95% CI: 0.01–0.42), respectively.
Conclusion
Body-weight gain in women during a hospital-based smoking-cessation program is associated with abstinence failure. Further multicenter studies, including participants of different races and cultural backgrounds, are warranted.
... To our knowledge, no study has evaluated a specific CBT for weight gain prevention while quitting smoking that comprehensively targeted post-cessation weight concerns, diet, activity and disordered eating among smokers with overweight or obesity (Hartmann-Boyce et al., 2021), which are key factors in the obesity field (Durrer Schutz et al., 2019;Paixao et al., 2020). In addition, no study to date has explored the effect of CM for smoking cessation among smokers with overweight or obesity. ...
Background
Post-cessation weight gain is a risk factor for relapse among quitters. The primary study aim was to evaluate, among smokers with overweight or obesity, the feasibility and acceptability of a cognitive-behavioral treatment (CBT) plus contingency management (CM) for quitting smoking and weight control. The secondary aim was to examine preliminary tobacco abstinence and weight change outcomes.
Methods
In an 8-week pilot randomized clinical trial, 41 participants (M age = 52.73, SD = 10.91, 56.1% females) with overweight or obesity (M BMI = 31.86, SD = 4.7) received a CBT for both quitting smoking and weight gain prevention (n = 24) or the same treatment plus CM (n = 17), consisting of providing incentives contingent upon smoking abstinence biochemically verified.
Results
Recruitment success rate was 80.39% (41/51), completion rate was 90.24% (37/41), and mean number of sessions attended (out of 15 possible) was 13.20 (SD = 3.1). Mean satisfaction rating for the treatment (1–10 likert-type scale with 10 being most satisfactory) was 9.73 (SD =.61). Preliminary efficacy data indicated that the CM group achieved higher abstinence rates compared with the CBT condition (100% vs. 58.33%, p =.007). Abstinent participants increased 1.25 kg (SD = 1.79) their baseline body weight at the end of treatment (p =.001).
Conclusions
Providing weight gain prevention strategies and CM within a smoking cessation treatment seems feasible and acceptable. Preliminary data indicated that including CM facilitates tobacco abstinence rates, nevertheless no advantage for CM was found for weight control.
... Withdrawal from nicotine not only increases the rewarding value of food but also elevates the threshold of the reward in the brain, which collectively lead to high energy-dense food consumption (25). A number of interventions such as a low-calorie diet, drug treatment, exercise, and nicotine replacement therapy have proved to be effective in lowering postcessation weight gain in the short term; however, it remains uncertain if there is an optimal intervention strategy to prevent long-term weight gain without undermining the chance of achieving abstinence (26). In the stratified analysis by postcessation weight gain among those who had ceased smoking, the risk reduction for total cancer was attenuated from 10% for participants with less than 10 kg of weight gain to 4% for those with 10 kg or more weight gain. ...
Background
It remains unknown how cancer risks vary by duration of smoking cessation and whether the benefit is attenuated by post-cessation weight gain.
Methods
We prospectively followed 198,565 persons from Nurses’ Health Study (NHS, 1978-2016), NHSII (1991-2017), and Health Professionals Follow-up Study (1988-2016) who were free of cancer at baseline. We used proportional hazard Cox models to compare cancer risk between current smokers and former smokers with different durations of smoking cessation and post-cessation weight gains.
Results
During 4,718,199 person-years of follow-up, we identified 32,456 cases of total cancer. Compared to current smokers, the risks for total and smoking-related cancer in past smokers were reduced to the level similar to never smokers after abstaining smoking for more than 26 years, with the hazard ratio of 0.69 (95% confidence interval [CI] = 0.63,0.76) for total cancer and 0.31 (95% CI = 0.26,0.37) for smoking related cancer, whereas no risk reduction was found for obesity-related cancer. Comparing former smokers to current smokers, the multivariable-adjusted hazard ratios for post-cessation weight gain of 0-5 kg, >5-10 kg, and ≥10 kg were 0.85 (95% CI = 0.81,0.89), 0.88 (95% CI = 0.83,0.93), and 0.93 (95% CI = 0.88,1.00) for total cancer; and 0.62 (95% CI = 0.58,0.67), 0.65 (95% CI = 0.60,0.71), and 0.71 (95% CI = 0.65,0.78) for total smoking-related cancer. In contrast, higher weight gain following smoking cessation was associated with a modest increased obesity-related cancer risk.
Conclusion
Smoking cessation overall has a strong net association with lower risk of total cancer irrespective of weight gain. However, this inverse association may be attenuated by substantial post-cessation weight gain, largely due to an increased risk of obesity-related cancers.
The Cochrane Tobacco Addiction Group has created risk of bias tools which are topic-agnostic. In 2012 the Cochrane Tobacco Addiction Group created guidance specific to considerations for reviews of randomized controlled trials of tobacco cessation interventions, building on existing Cochrane tools. The guidance covers issues relating to selection bias, performance bias, detection bias, attrition bias, and selective reporting. In this paper, we set out to make this guidance publicly available, so that others can use and cite it. We provide advice for using this tool to appraise trials critically as a systematic reviewer. We also provide guidance for triallists on ways to use this tool to improve trial design and reporting.
Introduction:
Interest in wellness interventions in substance use disorder (SUD) treatment is growing although evidence remains limited. This study evaluated nutrition, physical activity, nutrition and physical activity counseling, and relationships of counseling with wellness behavior before and after a wellness-oriented, tobacco-free policy intervention in 17 residential SUD programs.
Methods:
Clients completed cross-sectional surveys reporting sugar-sweetened beverage consumption, physical activity, and receipt of nutrition and physical activity counseling before (n= 434) and after (n = 422) an 18-month intervention. Multivariable regression models assessed pre-post-intervention differences in these variables and examined associations of nutrition counseling with sugar-sweetened beverage consumption and physical activity counseling with physical activity.
Results:
Post-intervention clients were 83% more likely than pre-intervention clients to report nutrition counseling (p = 0.024). There were no pre-post- differences for other variables. Past week sugar-sweetened beverage consumption was 22% lower among clients reporting nutrition counseling than for those who did not (p = 0.008) and this association did not vary by time (pre/post). There was a significant interaction of physical activity counseling receipt by time on past week physical activity (p = 0.008). Pre-intervention clients reporting physical activity counseling had 22% higher physical activity than those who did not; post-intervention clients reporting physical activity counseling had 47% higher physical activity.
Conclusion:
A wellness policy intervention was associated with increased nutrition counseling. Nutrition counseling predicted lower sugar-sweetened beverage consumption. Physical activity counseling predicted higher physical activity, an association that was greater post-intervention. Adding wellness components to tobacco-related interventions may promote health among SUD clients.
Background
The majority of Norwegians who use e-cigarettes are adults who have smoked. Little is known about vaping reasons and -patterns in this group. The aim of this paper was to study vaping prevalence, patterns, and motivations among adults who smoke. Furthermore, to investigate smoking intensity and smoking cessation behaviour differences between those who vape and those who do not.
Methods
This study was based on two separate Norwegian samples: People who had ever smoked, from 2017 (N = 2099), and people who currently smoked and recent quitters, from 2018/2019 (N = 1336). Measures of vape frequencies, vape motives, and smoking cessation behaviours were utilised in descriptive analyses of relationships between vaping and smoking behaviour.
Results
Less than 1 in 10 in the ever-smoked group, 1 in 5 of the currently smoked or recently quit group, were currently vaping. Ever trial rates for vaping were much higher at 1 in 3 in the ever-smoked group, and 1 in 2 in the currently smoked or recently quit group. Dual use with combustible cigarettes was common, but people who smoked tended to use e-cigarettes less frequently while those who formerly smoked tended to use them more frequently. Both quitting attempts and smoking intensity reduction were positively associated with vaping, and the most common reasons for e-cigarette use were reported to be desires to reduce harm, to stop smoking, or to reduce smoking intensity.
Conclusion
The results indicate that Norwegians who smoke tend to see e-cigarettes as a tool to reduce or completely stop smoking. The predominance of use-motivations related to reducing harm points at the importance of conveying correct information about relative harmfulness of tobacco- and nicotine products.
Background:
Post-cessation weight gain (PCWG) is an obstacle to smoking cessation. This trial evaluated a behavioral intervention targeting alternative rewards to smoking and high calorie snacking to promote smoking cessation while mitigating PCWG.
Methods:
Adult smokers (n = 288; 119 females, 169 males) received eight weeks of transdermal nicotine and were randomized to eight sessions of behavioral activation for smoking cessation and the mitigation of PCWG (BAS+) or standard smoking cessation counseling (SC). Primary outcomes were 7-day point prevalence abstinence and PCWG 26 weeks after the target quit date. Change in caloric intake from pre-treatment through the 26-week follow-up was a secondary outcome. Data were collected from September 2016 to February 2021, and analyses were completed in July 2022.
Results:
BAS+ and SC did not differ in smoking abstinence rates at the 26-week follow-up (OR=0.80, 95%CI 0.50-1.27, p = 0.34; 18% versus 23%). There were no significant differences in PCWG between BAS+ and SC who were 7-day point prevalence abstinent (β = -0.29, 95%CI -2.13 to 1.65, p = 0.77; 2.60 versus 2.20 pounds, respectively) or among those continuously abstinent (5.78 versus 5.34 pounds, respectively). There were no significant differences in caloric intake between BAS+ and SC from baseline to the 26-week follow-up (β = 110.65, 95%CI -96.72 to 318.02, p = 0.30; -19.1 versus -116.9 kcals/day, respectively).
Conclusions:
The results do not support the efficacy of BAS+ for smoking cessation and the prevention of PCWG. These findings join a growing body of research highlighting the challenge of minimizing PCWG and promoting smoking abstinence.
Purpose of Review
The recent rise in cardiovascular disease (CVD) deaths in the USA has sparked interest in identifying and implementing effective strategies to reverse this trend. Healthy lifestyle behaviors (i.e., healthy diet, regular physical activity, achieve and maintain a healthy weight, avoid tobacco exposure, good quality sleep, avoiding and managing stress) are the cornerstone for CVD prevention.
Recent Findings
Achieving all of these behaviors significantly benefits heart health; however, even small changes lower CVD risk. Moreover, there is interplay among healthy lifestyle behaviors where changing one may result in concomitant changes in another behavior. In contrast, the presence of one or more unhealthy lifestyle behaviors may attenuate changing another lifestyle behavior(s) (poor diet, inadequate physical activity, overweight/obesity, poor sleep quality, tobacco exposure, and poor stress management).
Summary
It is important to assess all of these lifestyle behaviors with patients to plan an intervention program that is best positioned for adherence.
Background
Smoking is a major risk factor for cardiovascular disease and smoking cessation reduces excess risk. E-cigarettes are popular for smoking cessation but there is little evidence on their cardiovascular health effect. Our objective was to compare the medium- and longer-term cardiovascular effects in smokers attempting to quit smoking using e-cigarettes with or without nicotine or prescription nicotine replacement therapy (NRT).
Methods
This was a single-center, pragmatic three-arm randomized (1:1:1) controlled trial, which recruited adult smokers (≥ 10 cigarettes/day), who were willing to attempt to stop smoking with support ( n = 248).
Participants were randomized to receive behavioral support with either (a) e-cigarettes with 18 mg/ml nicotine, (b) e-cigarettes without nicotine, and (c) NRT.
Flow-mediated dilation (%FMD) and peak cutaneous vascular conductance (CVCmax) responses to acetylcholine (ACh) and sodium nitroprusside (SNP), mean arterial pressure (MAP), and other outcomes were recorded at baseline, 3, and 6 months after stopping smoking. Data were analyzed using generalized estimating equations (GEE).
Results
At 3- and 6-month follow-up, %FMD showed an improvement over baseline in all three groups (e.g., p < 0.0001 at 6 months). Similarly, ACh, SNP, and MAP improved significantly over baseline in all groups both at 3 and 6 months (e.g., ACh: p = 0.004, at 6 months).
Conclusions
Smokers attempting to quit experienced positive cardiovascular impact after both a 3- and 6-month period. None of the groups (i.e., nicotine-containing and nicotine-free e-cigarettes or NRT) offered superior cardiovascular benefits to the others.
Trial registration
ClinicalTrials.gov NCT03061253 . Registered on 17 February 2017.
Background
Smoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke. By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely. The purpose of this pilot study is to identify barriers and facilitators to the use of and assess the preliminary effectiveness of EC as a harm reduction strategy among people with COPD.
Methods
In an open-label two-arm randomized controlled trial pilot study, 60 patients identified as smokers with a COPD diagnosis via electronic health records from a large urban health center are randomized in a 1:1 ratio to either standard care [counseling + nicotine replacement therapy (NRT)] or counseling + EC. The NRT arm will receive nicotine patches and nicotine lozenges for 12 weeks. The EC arm will receive EC for 12 weeks. Both cohorts will receive counseling from a licensed mental health counselor. Using ecological momentary assessment, participants will report their use of CC in both arms and EC use in the EC arm daily via text message. Primary outcomes will be feasibility and acceptability of intervention, and secondary outcomes will be reduction in CPD and change in COPD symptoms as measured by COPD Assessment Tool (CAT) score at 12-weeks. EC displacement of CC. To explore attitudes towards the use of EC as a harm-reduction strategy for patients with COPD, interviews will be performed with a sample of participants from both study arms.
Discussion
Despite decades of availability of smoking cessation medications, nearly half of people with COPD still smoke. This study aims to address the unmet need for feasible and effective strategies for reducing CC use among those with COPD, which has the potential to significantly improve the health of people with COPD who smoke.
Trial Registration ClinicalTrials.gov Identifier: NCT04465318.
With the recent rapid increase in obesity worldwide, metabolic syndrome (MetS) has gained significant importance. MetS is a cluster of obesity-related cardiovascular risk factors including abdominal obesity, atherogenic dyslipidemia, high blood pressure and impaired glucose tolerance. MetS is highly prevalent and strongly associated with an increased risk of developing diabetes and cardiovascular disease, putting a great burden on human society. Therefore, it is very important to reduce MetS risk, which can improve patients' cardiovascular prognosis. The primary and most effective strategy to control each component of MetS is lifestyle change such as losing body weight, keeping regular exercise, adopting a healthy diet, quitting smoking and alcohol drinking in moderation. Many studies have shown that lifestyle modification has improved all components of MetS, and reduces the incidence of diabetes and cardiovascular disease. Here, the Korean Society of CardioMetabolic Syndrome has summarized specific and practical methods of lifestyle modification in the management of MetS in the healthcare field.
Introduction
Tobacco harm reduction has potential to improve individual and population health. However, little research exists on low-intensity interventions, such as encouraging longer-term NRT or e-cigarette use. We aimed to determine whether: 1) encouraging use of nicotine products as long-term tobacco substitutes is more effective for smoking abstinence than standard treatment, and 2) offering e-cigarettes is more effective than NRT.
Methods
An open-label, parallel group randomised trial was conducted in Australia between 2014 and 2015, with 1563 adult daily smokers, randomised to: A) Standard cessation advice and NRT: advice to use NRT short-term B) Quit or substitute advice and NRT: advice to use NRT as a longer-term substitute for smoking if required to maintain smoking cessation or C) Quit or substitute advice and NRT and/or e-cigarettes. Participants were offered an initial supply of products they could then purchase for up to 7 months. The primary outcome was self-reported continuous smoking abstinence at 7 months. Point prevalence, dual use, and cigarette reduction were secondary outcomes.
Results
At 7 months, 2.8% (N=9) of group A (N=324) were abstinent, compared with 1.8% (N=11) in B (N=620) and 1.3% (N=8) in C (N=619) (Adjusted ORs: B vs A 0.66, 95% CI: 0.27-1.63; C vs A 0.46, 95% CI: 0.17-1.21; C vs B 0.69, 95% CI 0.27–1.73). There were no suspected unexpected serious adverse reactions associated with trial products.
Conclusion
A free trial of NRT and first generation e-cigarettes and advice on long-term substitution was no better for smoking abstinence than usual care.
Implications
This pragmatic trial allowed the comparison of existing and alternative policy options under semi-realistic conditions, such as product choice and financial cost. All trial arms had low rates of smoking cessation. The findings suggest that providing unflavoured cigalike e-cigarettes without additional support may not increase quitting compared with advice to use standard NRT in a general population of Australians who smoke. More intensive support and education, and/or opportunity to try a range of e-cigarette products, may be required to motivate quit attempts using e-cigarettes.
Worldwide, youth electronic cigarette use (vaping) has risen significantly over the past decade. This public health concern has spurred many high-quality studies characterizing country-specific prevalence, risk factors, physical and behavioral health complications, and optimal methods of assessment and counseling for youth vaping. Clinicians remain underexposed to this recent work, limiting translation of evidence into higher quality patient care. This review aims to provide pediatricians and other clinicians working with youth a clinically focused survey of key research findings and considerations based on recent evidence. This narrative review surveys emerging trends in EC use across different countries, reasons for youth vaping, characteristics of vaping materials that promote youth use, associations with combustible cigarette use, relation with cannabis and other illicit substances, physical and behavioral health risks associated with vaping, and methods of assessment, counseling, and intervention for problematic vaping in youth. Since vaping remains a relatively new phenomenon, long-term health consequences remain unknown.Conclusion: Youth vaping is an increasingly well-studied phenomenon with both physical and behavioral health risks. Pediatricians and other youth-focused clinicians can apply the lessons of recent research in work with youth and their families.
What is Known:
• Youth vaping is an increasingly prevalent public health concern.
• Recent research demonstrates physical and behavioral health risks associated with vaping as well as methods for assessment, counseling, and intervention.
What is New:
• The current review summarizes the latest evidence in a clinically focused framework to facilitate translation of emerging knowledge to practice.
Introduction:
Smoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods.
Methods and analysis:
A pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months.
Ethics and dissemination:
Approved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers.
Trial registration number:
ISRCTN47776579; Pre-results.
Background:
Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD), and it contributes to the development of many other serious diseases. Smoking cessation in COPD patients is known to improve survival and reduce the number of hospitalization-requiring acute exacerbations of COPD. However, smoking cessation interventions in these patients have only been successful for approximately 15-20% for consistent smoking abstinence in 12 months. Thus, more effective interventions are needed for this patient group. The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.
Methods:
This study is a randomized controlled trial. A total of 600 active smokers with COPD will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation program, "low intensity" group) or an intervention ("high-intensity" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and "buddy-matching" (smoker matched with COPD patient who has ceased smoking). Both groups will receive pharmacological smoking cessation. The primary endpoint is anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation after 12 months.
Discussion:
The potential benefit of this project is to improve smoking cessation rates and thereby reduce smoking-related exacerbations of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of other smoking-related diseases.
Trial registration:
ClinicalTrials.gov NCT04088942 . Registered on 13 September 2019.
Summary
Background
Smoking cessation is important in patients with tuberculosis because it can reduce the high rates of treatment failure and mortality. We aimed to assess the effectiveness and safety of cystine as a smoking cessation aid in patients with tuberculosis in Bangladesh and Pakistan.
Methods
We did a randomised, double-blind, placebo-controlled, trial at 32 health centres in Bangladesh and Pakistan. Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking. Patients were randomly assigned (1:1) to receive behavioural support plus either oral cytisine (9 mg on day 0, which was gradually reduced to 1·5 mg by day 25) or placebo for 25 days. Randomisation was done using pregenerated block randomisation lists, stratified by trial sites. Investigators, clinicians, and patients were masked to treatment allocation. The primary outcome was continuous abstinence at 6 months, defined as self-report (of not having used more than five cigarettes, bidis, a water pipe, or smokeless tobacco products since the quit date), confirmed biochemically by a breath carbon monoxide reading of less than 10 parts per million. Primary and safety analysis were done in the intention-to-treat population. This trial is registered with the International Standard Randomised Clinical Trial Registry, ISRCTN43811467, and enrolment is complete.
Findings
Between June 6, 2017, and April 30, 2018, 2472 patients (1527 patients from Bangladesh; 945 patients from Pakistan) were enrolled and randomly assigned to receive cytisine (n=1239) or placebo (n=1233). At 6 months, 401 (32·4%) participants in the cytisine group and 366 (29·7%) participants in the placebo group had achieved continuous abstinence (risk difference 2·68%, 95% CI −0·96 to 6·33; relative risk 1·09, 95% CI 0·97 to 1·23, p=0·114). 53 (4·3%) of 1239 participants in the cytisine group and 46 (3·7%) of 1233 participants in the placebo group reported serious adverse events (94 events in the cytisine group and 90 events in the placebo group), which included 91 deaths (49 in the cytisine group and 42 in the placebo group). None of the adverse events were attributed to the study medication.
Interpretation
Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.
Background:
Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies.
Objective:
This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology.
Methods:
A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial.
Results:
In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study.
Conclusions:
The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence-based future approaches.
Trial registration:
ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173.
International registered report identifier (irrid):
RR2-10.2196/12464.
Background
Smoking cessation improves morbidity and mortality among smokers who achieve long-term abstinence. Many smokers are using e-cigarettes to attempt to quit, despite a lack of data concerning their efficacy and safety for smoking cessation.
Methods
The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) trial is a multi-centre randomized controlled trial (NCT02417467) with a treatment period of 12 weeks and follow-up of 52 weeks. A total of 376 participants motivated to quit smoking were enrolled at 17 Canadian centres (November 2016 to September 2019). Participants were randomized (1:1:1) to one of three treatment arms: nicotine e-cigarettes, non-nicotine e-cigarettes, or no e-cigarettes. All groups received individual counselling. Treatment allocation was double-blind for the e-cigarette groups. The trial includes follow-ups by telephone at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52. The primary endpoint is to compare nicotine e-cigarettes to counselling alone in terms of biochemically-validated point-prevalence smoking abstinence at 12 weeks; the primary endpoint was changed from 52 weeks following early termination (77% of targeted enrollment) due to a prolonged delay in e-cigarette manufacturing. The secondary objectives are to examine the efficacy of nicotine and non-nicotine e-cigarettes in terms of point-prevalence and continuous smoking abstinence, and reduction in daily cigarette consumption at all follow-ups through week 52, and to describe the occurrence of adverse events.
Conclusion
The E3 Trial will provide regulators, health care professionals, and smokers with important information about the efficacy and safety of e-cigarettes for smoking cessation.
Introduction:
Most people who stop smoking gain weight. Dietary modification may seem an obvious solution, but food restriction may increase cigarette craving and smoking relapse.
Trial design:
An unblinded parallel randomised controlled trial.
Methods:
Participants were adult smokers with a body mass index greater or equal to 23 kg/m2. Setting was National Health Service commissioned Stop Smoking Services, interventions were referral to a commercial weight management programme, plus stop smoking support (treatment group), compared with stop smoking support alone (control group). Objective was to compare weight change between interventions in smoking abstainers and not abstinent rates in all. Primary outcome was change in weight (kg) at 12 weeks. Randomisation sequence was computer generated and concealed until allocation.
Results:
Seventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group. Change in weight was analysed in long-term abstainers (13 treatment, 14 control) only because the aim was to prevent weight gain associated with smoking cessation. Abstinence was analysed on an intention-to-treat basis (37 treatment, 39 control). At 12 weeks weight gain was less in the treatment than the control group with an adjusted mean difference of -2.3 kg 95% CI (-4.4 to -0.1). Craving scores were lower (Mood and Physical Symptoms Scale craving domain -1.6 (-2.7 to -0.5)) and quit rates were higher in the treatment than the control group (32% vs 21%), although the trial was not powered to superiority in cravings and quit rates. No adverse events or side effects were reported.
Conclusion:
In people who are obese and want to quit smoking, these data provide modest encouragement that providing weight management at the time of quitting may be helpful. Those who are not obese, but who are informed about potential weight gain during their quit attempt, were uninterested in a weight management programme.
Trial registration number:
ISRCTN65705512.
Background:
Smoking rates are high in adults with anxiety disorders (ADs), yet little is known about the safety and efficacy of smoking-cessation pharmacotherapies in this group.
Methods:
Post hoc analyses in 712 smokers with AD (posttraumatic stress disorder [PTSD], n = 192; generalized anxiety disorder [GAD], n = 243; panic disorder [PD], n = 277) and in a nonpsychiatric cohort (NPC; n = 4,028). Participants were randomly assigned to varenicline, bupropion, nicotine-replacement therapy (NRT), or placebo plus weekly smoking-cessation counseling for 12 weeks, with 12 weeks follow-up. General linear models were used to test the effects of treatment group, cohort, and their interaction on neuropsychiatric adverse events (NPSAEs), and continuous abstinence weeks 9-12 (treatment) and 9-24 (follow-up).
Results:
NPSAE incidence for PTSD (6.9%), GAD (5.4%), and PD (6.2%) was higher versus NPC (2.1%), regardless of treatment. Across all treatments, smokers with PTSD (odds ratio [OR] = 0.58), GAD (OR = 0.72), and PD (OR = 0.53) had lower continuous abstinence rates weeks 9-12 (CAR9-12) versus NPC. Varenicline demonstrated superior efficacy to placebo in smokers with GAD and PD, respectively (OR = 4.53; 95% confidence interval [CI] = 1.20-17.10; and OR = 8.49; 95% CI = 1.57-45.78); NRT was superior to placebo in smokers with PD (OR = 7.42; 95% CI = 1.37-40.35). While there was no statistically significant effect of any treatment on CAR9-12 for smokers with PTSD, varenicline improved 7-day point prevalence abstinence at end of treatment in this subcohort.
Conclusion:
Individuals with ADs were more likely than those without psychiatric illness to experience moderate to severe NPSAEs during smoking-cessation attempts, regardless of treatment. While the study was not powered to evaluate abstinence outcomes with these subgroups of smokers with ADs, varenicline provided significant benefit for cessation in those with GAD and PD, while NRT provided significant benefit for those with PD.
Data on the association between lung function and some dietary patterns have been published. However, it is not yet well known if whether the Mediterranean Diet (MD) pattern can preserve or improve lung function. Our purpose is to evaluate the effect of increased MD adherence on lung function in smokers. A multicenter, parallel, cluster-randomized, controlled clinical trial is proposed. A total of 566 active smokers (>10 packs-year), aged 25–75 years will be included, without previous respiratory disease and who sign an informed consent to participate. Twenty Primary Care Centres in Tarragona (Spain) will be randomly assigned to a control or an intervention group (1:1). All participants will receive advice to quit smoking, and the intervention group, a nutritional intervention (2 years) designed to increase MD adherence by: (1) annual visit to deliver personalized nutritional education, (2) annual telephone contact to reinforce the intervention, and (3) access to an online dietary blog. We will evaluate (annually for 2 years): pulmonary function by forced spirometry and MD adherence by a 14-item questionnaire and medical tests (oxidation, inflammation and consumption biomarkers). In a statistical analysis by intention-to-treat basis, with the individual smoker as unit of analysis, pulmonary function and MD adherence in both groups will be compared; logistic regression models will be applied to analyze their associations. We hope to observe an increased MD adherence that may prevent the deterioration of lung function in smokers without previous respiratory disease. This population may benefit from a dietary intervention, together with the recommendation of smoking cessation.
Objective:
To evaluate the efficacy in smoking cessation and safety of 2 and 4 mg nicotine mint lozenges in Chinese adult smokers.
Methods:
This was a multicenter, randomized, stratified, double-blind, placebo-controlled, parallel-group study. The low-dependence stratum included 483 smokers (241 randomized to active 2 mg nicotine lozenge and 242 to placebo lozenge). The high-dependence stratum included 240 smokers (120 randomized to active 4 mg nicotine lozenge and 120 to placebo lozenge). The primary endpoint was successful smoking cessation at 6 weeks postquit, defined as continuous abstinence from smoking for the 28-day period up to and including the 6-week visit (verified by CO measurement). Cochran-Mantel-Haenszel tests were performed to compare quit rates between active nicotine and placebo separately for the high-dependence and low-dependence strata.
Results:
The primary analysis showed that in the low-dependence (2 mg) stratum, 59 subjects (24.5%) of 241 in the active nicotine group and 52 subjects (21.5%) of 242 in the placebo group were successful quitters (P = .3851). In the high-dependence (4 mg) stratum, 37 subjects (30.8%) of 120 in the active nicotine group and 24 subjects (20.2%) of 119 in the placebo group were successful quitters (P = .0565).
Conclusions:
The 4 mg nicotine lozenge provided a directionally significant improvement in smoking cessation rates compared with placebo in Chinese adult smokers with high nicotine dependence for the primary endpoint. The 2 mg nicotine lozenge provided higher, but nonsignificant, smoking cessation rates than placebo. Both nicotine lozenges were generally well tolerated in Chinese adult smokers.
Tobacco smoking is a global pandemic that poses substantial health burdens and costs. With nearly six million deaths annually, smoking is the single most important cause of avoidable premature mortality in the world, mainly from lung cancer, coronary heart disease, chronic obstructive pulmonary disease and stroke. Smoking is a very difficult addiction to break, even for those with a strong desire to quit. Electronic cigarettes are an attractive long-term alternative source of nicotine to conventional cigarettes because of their many similarities with smoking. Electronic cigarette users report buying them to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, to quit, and to continue having a 'smoking' experience, but with reduced health risks. Actually, there aren't antismoking treatments for people who smoke only electronic cigarette (single users) or electronic cigarette and classic cigarette (dual users). There isn't any specific information on the efficacy and safety of new pharmacological support for electronic cigarette users. We propose that smoking cessation with varenicline plus counselling delivered to electronic cigarette users could be associated with similar smoking abstinence rates compared to the results obtained in the general population. Herein, we describe the methodology of a double-blind, placebo-controlled, randomized clinical trial, of 24 weeks duration, that examines the efficacy of varenicline (1 mg BID - for 12 weeks) plus counselling compared to matched placebo (1 mg BID - for 12 weeks) plus counselling.
Introduction
Electronic cigarettes (EC) mainly with nicotine content are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy and safety as an aid for smoking cessation are lacking.
Methods and analysis
Design: randomised, placebo and reference treatment-controlled, multicentre, double-blind, double-dummy, parallel-group trial. Participants: smokers smoking at least 10 cigarettes/day in the past year and motivated to quit, aged 18–70 years. Interventions : (A) EC without nicotine (ECwoN) plus placebo tablets of varenicline administered by oral route: placebo condition , (B) EC with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition. Voltage regulated EC will be used with liquid containing 12 mg/mL of nicotine for ad libitum use. Flavour : blond tobacco. (C) Reference : ECwoN plus 0.5 mg varenicline tablets: varenicline condition. Varenicline administered according to the marketing authorisationauthorisation. Treatment duration : 1 week+3 months. Primary outcome: continuous smoking abstinence rate (CAR) (abstinence from conventional/combustible cigarettes) during the last 4 weeks (weeks 9–12) of the treatment period defined as self-report of no smoking during the previous 2 weeks and expired air carbon monoxide ≤8 at visit 4 at week 10 after target quit date (TQD), that is, 11 weeks after treatment initiation AND at visit 5, week 12 after TQD, that is, 13 weeks after treatment initiation. Secondary outcomes : safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms with respect of baseline.
Ethics and dissemination
The ethics committee approval was obtained on 17 April 2018. All data collected about the study participants will be anonymised. Investigators will communicate trial results to participants, health authorities, healthcare professionals, the public and other relevant groups without any publication restrictions.
Trial registration number
NCT03630614 ; Pre-results.
Background:
Weight gain frequently occurs after smoking cessation (SC); the risk of new-onset diabetes mellitus increases for several years after SC. However, no large-scale, randomized controlled trials have examined the effects of nutritional guidance on post-SC cardiovascular risk. The current trial will enroll individuals who successfully quit smoking with the help of a SC clinic and who gain weight, to determine the effects of nutritional guidance on cardiovascular, glucose, and lipid metabolism biomarkers.
Methods/design:
This is a multicenter, prospective, parallel-group, randomized controlled trial. Some 250 individuals who successfully quit smoking with the help of a SC clinic and who gain weight (an increase of ≥ 1.25% Body Mass Index (BMI) between the first and the fifth visit to the SC clinic) will be enrolled within 1 month of the final (fifth) visit to the SC clinic. These participants will be randomly assigned to an intervention group (125 individuals receiving nutritional guidance) or a control group (125 individuals not receiving nutritional guidance). A registered dietitian will provide nutritional guidance once every 3 months for a total of three sessions. The primary endpoint for this trial will be the level of adiponectin, a predictor of cardiovascular risk that reflects weight and smoking status. Secondary endpoints will be levels of cardiovascular, glucose, and lipid metabolism biomarkers, BMI, abdominal circumference, and the percentage of individuals who quit smoking for a prolonged period.
Discussion:
This trial will determine the benefits of nutritional guidance with respect to post-SC weight gain. The findings should provide useful information for devising a quality protocol for SC education to prevent cardiovascular disease.
Trial registration:
The study is registered at the University Hospital Medical Information Network Clinical Trials Registry ( UMIN000030282 ). Registered on 6 December 2017.
Background
Nicotine preloading means using nicotine replacement therapy prior to a quit date while smoking normally. The aim is to reduce the drive to smoke, thereby reducing cravings for smoking after quit day, which are the main cause of early relapse. A prior systematic review showed inconclusive and heterogeneous evidence that preloading was effective and little evidence of the mechanism of action, with no cost-effectiveness data.
Objectives
To assess (1) the effectiveness, safety and tolerability of nicotine preloading in a routine NHS setting relative to usual care, (2) the mechanisms of the action of preloading and (3) the cost-effectiveness of preloading.
Design
Open-label randomised controlled trial with examination of mediation and a cost-effectiveness analysis.
Setting
NHS smoking cessation clinics.
Participants
People seeking help to stop smoking.
Interventions
Nicotine preloading comprised wearing a 21 mg/24 hour nicotine patch for 4 weeks prior to quit date. In addition, minimal behavioural support was provided to explain the intervention rationale and to support adherence. In the comparator group, participants received equivalent behavioural support. Randomisation was stratified by centre and concealed from investigators.
Main outcome measures
The primary outcome was 6-month prolonged abstinence assessed using the Russell Standard. The secondary outcomes were 4-week and 12-month abstinence. Adverse events (AEs) were assessed from baseline to 1 week after quit day. In a planned analysis, we adjusted for the use of varenicline (Champix ® ; Pfizer Inc., New York, NY, USA) as post-cessation medication. Cost-effectiveness analysis took a health-service perspective. The within-trial analysis assessed health-service costs during the 13 months of trial enrolment relative to the previous 6 months comparing trial arms. The base case was based on multiple imputation for missing cost data. We modelled long-term health outcomes of smoking-related diseases using the European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) model.
Results
In total, 1792 people were eligible and were enrolled in the study, with 893 randomised to the control group and 899 randomised to the intervention group. In the intervention group, 49 (5.5%) people discontinued preloading prematurely and most others used it daily. The primary outcome, biochemically validated 6-month abstinence, was achieved by 157 (17.5%) people in the intervention group and 129 (14.4%) people in the control group, a difference of 3.02 percentage points [95% confidence interval (CI) –0.37 to 6.41 percentage points; odds ratio (OR) 1.25, 95% CI 0.97 to 1.62; p = 0.081]. Adjusted for use of post-quit day varenicline, the OR was 1.34 (95% CI 1.03 to 1.73; p = 0.028). Secondary abstinence outcomes were similar. The OR for the occurrence of serious AEs was 1.12 (95% CI 0.42 to 3.03). Moderate-severity nausea occurred in an additional 4% of the preloading group compared with the control group. There was evidence that reduced urges to smoke and reduced smoke inhalation mediated the effect of preloading on abstinence. The incremental cost-effectiveness ratio at the 6-month follow-up for preloading relative to control was £710 (95% CI –£13,674 to £23,205), but preloading was dominant at 12 months and in the long term, with an 80% probability that it is cost saving.
Limitations
The open-label design could partially account for the mediation results. Outcome assessment could not be blinded but was biochemically verified.
Conclusions
Use of nicotine-patch preloading for 4 weeks prior to attempting to stop smoking can increase the proportion of people who stop successfully, but its benefit is undermined because it reduces the use of varenicline after preloading. If this latter effect could be overcome, then nicotine preloading appears to improve health and reduce health-service costs in the long term. Future work should determine how to ensure that people using nicotine preloading opt to use varenicline as cessation medication.
Trial registration
Current Controlled Trials ISRCTN33031001.
Funding
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 41. See the NIHR Journals Library website for further project information.
We evaluated the impact of intensive smoking cessation activities as an adjunct to anti-tuberculosis treatment on patient-related treatment outcomes. In this open-label, randomised controlled trial, self-reporting smokers with pulmonary tuberculosis who initiated standard anti-tuberculosis treatment were randomised to either nicotine replacement therapy and behaviour change counselling (n = 400) or counselling alone (n = 400) provided at baseline and two follow-up visits. The primary outcomes were change in TBscore at 24-weeks and culture conversion at 8-weeks. Biochemical smoking quit rates defined as serum cotinine levels <10 ng/mL and/or exhaled carbon monoxide levels <6 ppm (47·8% vs 32·4%, p-value =< 0·001) and self-reported quit rates (69.3% vs 38·7%, p-value =< 0·001) were significantly higher in the intervention arm at 24-weeks. Though the TBscores at 24 weeks (95% CI) were lower in the intervention arm [2·07 (1·98, 2·17) versus 2.12 (2·02, 2·21)], the difference was not clinically meaningful. Patients in the control arm required treatment extension more often than intervention arm (6·4% vs 2·6%, p-value = 0·02). Combining nicotine replacement therapy with behaviour change counselling resulted in significantly higher quit rates and lower cotinine levels, however, impact on patient-related (TBscore) or microbiological outcomes (culture conversion) were not seen.
Background:
Smoking cessation often results in weight gain which discourages many smokers from quitting and can increase health risks. Treatments to reduce cessation-related weight gain have been tested in highly controlled trials of in-person treatment, but have never been tested in a real-world setting, which has inhibited dissemination.
Methods:
The Best Quit Study (BQS) is a replication and "real world" translation using telephone delivery of a prior in-person efficacy trial.
Design:
randomized control trial in a quitline setting. Eligible smokers (n = 2540) were randomized to the standard 5-call quitline intervention or quitline plus simultaneous or sequential weight management. Regression analyses tested effectiveness of treatments on self-reported smoking abstinence and weight change at 6 and 12 months.
Results:
Study enrollees were from 10 commercial employer groups and three state quitlines. Participants were between ages 18-72, 65.8% female, 68.2% white; 23.0% Medicaid-insured, and 76.3% overweight/obese. The follow-up response rate was lower in the simultaneous group than the control group at 6 months (p = 0.01). While a completers analysis of 30-day point prevalence abstinence detected no differences among groups at 6 or 12 months, multiply imputed abstinence showed quit rate differences at 6 months for:simultaneous (40.3%) vs. sequential (48.3%), p = 0.034 and simultaneous vs. control (44.9%), p = 0.043. At 12 months, multiply imputed abstinence, was significantly lower for the simultaneous group (40.7%) vs. control (46.0%), p < 0.05 and vs. sequential (46.3%), p < 0.05. Weight gain at 6 and 12 months was minimal and not different among treatment groups. The sequential group completed fewer total calls (3.75) vs. control (4.16) and vs. simultaneous group (3.83), p = 0.01, and fewer weight calls (0.94) than simultaneous (2.33), p < 0.0001. The number of calls completed predicted 30-day abstinence, p < 0.001, but not weight outcomes.
Discussion:
This study offers a model for evaluating population-level public health interventions conducted in partnership with tobacco quitlines.
Conclusions:
Simultaneous (vs. sequential) delivery of phone/web weight management with cessation treatment in the quitline setting may adversely affect quit rate. Neither a simultaneous nor sequential approach to addressing weight produced any benefit on suppressing weight gain. This study highlights the need and the challenges of testing intensive interventions in real-world settings.
Trial registration:
ClinicalTrials.gov Identifier: NCT01867983 . Registered: May 30, 2013.
Background and aims
Tuberculosis (TB) patients who quit smoking have much better disease outcomes than those who continue to smoke. Behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit, in general populations. However, there is no evidence for the effectiveness of this strategy in TB patients who smoke. We will assess the safety, effectiveness and cost‐effectiveness of cytisine – a low‐cost plant‐derived nicotine substitute – for smoking cessation in TB patients compared with placebo, over and above brief behavioural support.
Design
Two‐arm, parallel, double‐blind, placebo‐controlled, multi‐centre (30 sites in Bangladesh and Pakistan), individually randomised trial.
Setting
TB treatment centres integrated into public health care systems in Bangladesh and Pakistan.
Participants
Newly diagnosed (in the last four weeks) adult pulmonary TB patients who are daily smokers (with or without dual smokeless tobacco use) and are interested in quitting (n= 2,388).
Measurements
The primary outcome measure is biochemically verified continuous abstinence from smoking at six months post‐randomization, assessed using Russell Standard criteria. The secondary outcome measures include continuous abstinence at 12 months, lapses and relapses; clinical TB outcomes; nicotine dependency and withdrawal; and adverse events.
Comments
This is the first smoking cessation trial of cytisine in low‐ and middle‐income countries evaluating both cessation and tuberculosis (TB) outcomes. If found effective, cytisine could become the most affordable cessation intervention to help TB patients who smoke.
Objective: The rates of obesity and cigarette smoking are much higher in patients with schizophrenia compared to the general population. This study was to examine whether naltrexone and bupropion combination treatment can help weight loss and smoking cessation in patients with schizophrenia.
Methods: Obese male schizophrenia patients with current cigarette smoking were randomized to receive adjunctive naltrexone (25 mg/day) and bupropion (300 mg/day) combination or placebo for 24 weeks. Twenty-two patients were enrolled in the study, and 21 patients completed the study (11 in the treatment group, and 10 in the placebo group). Body weight, body mass index (BMI), fasting lipids, smoking urge, expired carbon monoxide (CO) level and cigarettes smoked per week were measured at baseline and week 24.
Results: There was no significant difference between two groups in changes in weight, BMI, fasting lipids, or cigarette smoking measures (p's > 0.05)
Conclusion: Naltrexone and bupropion combination treatment didn't show weight loss or smoking cessation effect in patients with schizophrenia in this pilot study.Implications for future studies were discussed.
ClinicalTrials.gov identifier: NCT02736474.
Background
The cost-effectiveness of varenicline has been demonstrated in the US health care setting using the Benefits of Smoking Cessation on Outcomes (BENESCO) model to simulate the lifetime direct costs and consequences of a hypothetical cohort of US adult smokers who make a single attempt to quit. The aim of this study was to undertake an updated cost-effectiveness analysis, using current epidemiology inputs and recently published smoking cessation data from the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES), the largest clinical trial of smoking cessation pharmacotherapies conducted to date.
Methods
BENESCO is a Markov model simulating the effect of a single attempt to quit smoking on four smoking-related diseases: coronary heart disease, stroke, chronic obstructive lung disease, and lung cancer. Inputs were updated to include efficacy from EAGLES and newer data for the epidemiology of smoking in the US, the epidemiology and direct treatment costs of the four morbidities, and the costs of the interventions. Analyses compared varenicline, bupropion, nicotine replacement therapy (NRT) patch, and placebo with regard to the incidence of smoking-related morbidity, the incidence of smoking-related mortality, and cost-effectiveness at a time horizon from 2 years to lifetime.
Results
The study cohort comprised of 18,394,068 US adult smokers who made a single quit attempt during the first year of the model. For varenicline, there were an estimated 319,730 fewer smoking-related morbidities at the lifetime compared with placebo. Similarly, smoking-related mortality decreased by 198,240 subjects when varenicline was compared with placebo. For the same time horizon, varenicline was more effective and less costly, ie, dominant, compared with all comparators in the cost-effectiveness analysis.
Conclusion
Based on the BENESCO model, smoking cessation with varenicline results in reduced incidence of smoking-related morbidity and mortality compared with other smoking cessation interventions and remains a cost-effective strategy in the US population.
Aims:
This study aimed to investigate the association between smoking cessation, post-cessation body mass index (BMI) change and risk of myocardial infarction (MI) and stroke in men.
Methods and results:
A prospective cohort study using the National Health Insurance Service (NHIS) data set collected from 2002 to 2013 was implemented. Based on the first (2002-03) and second (2004-05) NHIS health check-up periods, 108 242 men aged over 40 years without previous diagnoses of MI or stroke were grouped into sustained smokers, quitters with BMI gain, quitters without BMI change, quitters with BMI loss, and non-smokers. Body mass index change was defined as the difference of more than 1.0 kg/m2 between the two health check-up periods. The participants were followed-up from 1 January 2006 to 31 December 2013. Hazard ratios (HRs) and 95% confidence intervals (HR, 95% CI) were computed using Cox proportional hazard models adjusted for sociodemographic, health status, and family health history. Compared to the sustained smokers, the risk of MI and stroke was significantly reduced in both quitters with BMI gain (HR 0.33; 95% CI 0.16-0.70 for MI and HR 0.75; 95% CI 0.57-1.00 for stroke) and without BMI change (HR 0.55; 95% CI 0.37-0.83 for MI and HR 0.75; 95% CI 0.62-0.92 for stroke), but no significant association was found in quitters with BMI loss (HR 0.91; 95% CI 0.43-1.91 for MI and HR 0.86; 95% CI 0.57-1.31 for stroke), respectively. Non-smokers had lower risk of MI (HR 0.37; 95% CI 0.32-0.43) and stroke (HR 0.68; 95% CI 0.64-0.73) compared to the sustained smokers.
Conclusion:
Post-cessation BMI change did not significantly modify the protective association of smoking cessation with MI and stroke.
Background
Rheumatoid arthritis (RA) is a chronic, inflammatory rheumatic disease with the potential to induce significant disability. Patients with RA are at increased risk of cardiovascular diseases (CVD). Smokers with RA tend to experience more pain and fatigue, higher disease activity, more erosive joint destruction and a lower health-related quality of life (HR-QoL) than non-smokers. It remains to be determined whether these effects can be reduced by smoking cessation.
This randomised controlled trial (RCT) in patients with RA aims to examine the effect of intensive smoking cessation intervention (motivational counselling combined with tailored nicotine replacement therapy) versus standard care on smoking cessation, and consequently on disease activity. Secondary objectives are to explore the effect on flare, risk factors for CVD, lung function, physical function, HR-QoL, pain and fatigue in patients with RA.
Methods
This will be a multicentre, open label, two arm, parallel group, RCT, including 150 daily smokers with RA, being in remission or having low-moderate disease activity (DAS28 ≤ 5.1). The intervention group (n = 75) will receive five counselling sessions with a trained smoking cessation counsellor based on the principles of motivational counselling. Furthermore, intervention patients will be offered nicotine replacement therapy tailored to individual needs. Participants randomised to the control group will receive standard care. The co-primary outcome is a hierarchical endpoint, which will be evaluated at 3 months follow-up and will include (1) self-reported smoking cessation biochemically validated by exhaled carbon monoxide and (2) achievement of EULAR clinical response (an improvement in DAS28 of > 0.6). Follow-up visits will be performed at 3, 6 and 12 months post-intervention.
Discussion
This trial will reveal whether intensive smoking cessation counselling helps smokers with RA to achieve continuous smoking cessation and whether, as a concomitant benefit, it will reduce their RA disease activity. The trial aims to generate high quality evidence for the feasibility of a health promotion intervention for smokers with RA.
Trial registration
ClinicalTrials.gov, identifier: NCT02901886. Registered on 10 September 2016. Recruitment status updated on 10th October 2016.
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-017-2309-5) contains supplementary material, which is available to authorized users.
[Purpose] This study aimed to analyze the effects of complex training on carbon monoxide, cardiorespiratory function, and body mass among lege students with the highest smoking rate among all age group. [Subjects and Methods] A total of 40 lege students voluntarily participated in this study. All subjects smoked and were randomly divided into two groups: the experimental group (N=20) and the control group (N=20). The experimental group underwent complex training (30 min of training five times a week for 12 weeks) while the control group did not participate in such training. The complex training consisted of two parts: aerobic exercise (walking and running) and resistance exercise (weight training). [Results] Two-way ANOVA with repeated measures revealed significant interactions among CO, VO2max, HRmax, VEmax, body fat, and skeletal muscle mass, indicating that the changes were significantly different among groups. [Conclusion] A 12 week of complex physical exercise program would be an effective way to support a stop-smoking campaign as it quickly eliminates CO from the body and improves cardiorespiratory function and body condition.
Background: Current guidelines recommend smoking cessation and weight management for secondary prevention in post-myocardial infarction (MI) patients. However, little is known about the effects of smoking cessation on weight change post-MI.
Methods: We examined this question using data from a randomized, double-blind, placebo-controlled trial investigating the effect of bupropion on smoking cessation in patients immediately following a MI. Weight change was compared between 3 groups: patients who reported complete abstinence, those who reported intermittent smoking, and those who reported persistent smoking during the 12-month follow-up. Analyses were restricted to patients who attended all follow-up visits (N=179). Weight was collected by research nurses at follow-up. Abstinence was defined by self-report in the previous 7 days and a carbon monoxide level ≤10 ppm.
Results: During follow-up, 92 patients were abstinent, 49 were intermittently smoking, and 38 were consistently smoking. At baseline, 68.7% of patients were male, and the mean age was 53.9 years (SD 10.0). The mean weight and BMI at baseline were 78.4 kg (SD 17.7) and 27.3 kg/m ² (SD 5.0), respectively. Mean body weight increased in all 3 groups during follow-up ( Figure ). However, patients who remained abstinent were more likely to gain weight than those who smoked persistently (difference 3.3 kg, 95% CI 0.9, 5.6). No difference in weight change was present between persistent and intermittent smokers. Both intermittent and persistent smokers reduced their daily cigarette consumption between baseline and 12-month follow-up (mean difference −15.5, 95% CI −19.1, −11.9 and −15.8, 95% CI, −19.9, −11.7, respectively).
Conclusions: Patients who remain abstinent are more likely to gain weight 12 months post-MI. Given the importance of weight management in this population, strategies to ensure long-term weight control among patients who quit smoking are needed.
Background:
Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol formed by heating an e-liquid. People who smoke report using ECs to stop or reduce smoking, but some organisations, advocacy groups and policymakers have discouraged this, citing lack of evidence of efficacy and safety. People who smoke, healthcare providers and regulators want to know if ECs can help people quit and if they are safe to use for this purpose. This review is an update of a review first published in 2014.
Objectives:
To evaluate the effect and safety of using electronic cigarettes (ECs) to help people who smoke achieve long-term smoking abstinence.
Search methods:
We searched the Cochrane Tobacco Addiction Group's Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO for relevant records to January 2020, together with reference-checking and contact with study authors.
Selection criteria:
We included randomized controlled trials (RCTs) and randomized cross-over trials in which people who smoke were randomized to an EC or control condition. We also included uncontrolled intervention studies in which all participants received an EC intervention. To be included, studies had to report abstinence from cigarettes at six months or longer and/or data on adverse events (AEs) or other markers of safety at one week or longer.
Data collection and analysis:
We followed standard Cochrane methods for screening and data extraction. Our primary outcome measures were abstinence from smoking after at least six months follow-up, AEs, and serious adverse events (SAEs). Secondary outcomes included changes in carbon monoxide, blood pressure, heart rate, blood oxygen saturation, lung function, and levels of known carcinogens/toxicants. We used a fixed-effect Mantel-Haenszel model to calculate the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes. For continuous outcomes, we calculated mean differences. Where appropriate, we pooled data from these studies in meta-analyses.
Main results:
We include 50 completed studies, representing 12,430 participants, of which 26 are RCTs. Thirty-five of the 50 included studies are new to this review update. Of the included studies, we rated four (all which contribute to our main comparisons) at low risk of bias overall, 37 at high risk overall (including the 24 non-randomized studies), and the remainder at unclear risk. There was moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine EC than in those randomized to nicotine replacement therapy (NRT) (risk ratio (RR) 1.69, 95% confidence interval (CI) 1.25 to 2.27; I2 = 0%; 3 studies, 1498 participants). In absolute terms, this might translate to an additional four successful quitters per 100 (95% CI 2 to 8). There was low-certainty evidence (limited by very serious imprecision) of no difference in the rate of adverse events (AEs) (RR 0.98, 95% CI 0.80 to 1.19; I2 = 0%; 2 studies, 485 participants). SAEs occurred rarely, with no evidence that their frequency differed between nicotine EC and NRT, but very serious imprecision led to low certainty in this finding (RR 1.37, 95% CI 0.77 to 2.41: I2 = n/a; 2 studies, 727 participants). There was moderate-certainty evidence, again limited by imprecision, that quit rates were higher in people randomized to nicotine EC than to non-nicotine EC (RR 1.71, 95% CI 1.00 to 2.92; I2 = 0%; 3 studies, 802 participants). In absolute terms, this might again lead to an additional four successful quitters per 100 (95% CI 0 to 12). These trials used EC with relatively low nicotine delivery. There was low-certainty evidence, limited by very serious imprecision, that there was no difference in the rate of AEs between these groups (RR 1.00, 95% CI 0.73 to 1.36; I2 = 0%; 2 studies, 346 participants). There was insufficient evidence to determine whether rates of SAEs differed between groups, due to very serious imprecision (RR 0.25, 95% CI 0.03 to 2.19; I2 = n/a; 4 studies, 494 participants). Compared to behavioural support only/no support, quit rates were higher for participants randomized to nicotine EC (RR 2.50, 95% CI 1.24 to 5.04; I2 = 0%; 4 studies, 2312 participants). In absolute terms this represents an increase of six per 100 (95% CI 1 to 14). However, this finding was very low-certainty, due to issues with imprecision and risk of bias. There was no evidence that the rate of SAEs varied, but some evidence that non-serious AEs were more common in people randomized to nicotine EC (AEs: RR 1.17, 95% CI 1.04 to 1.31; I2 = 28%; 3 studies, 516 participants; SAEs: RR 1.33, 95% CI 0.25 to 6.96; I2 = 17%; 5 studies, 842 participants). Data from non-randomized studies were consistent with RCT data. The most commonly reported AEs were throat/mouth irritation, headache, cough, and nausea, which tended to dissipate over time with continued use. Very few studies reported data on other outcomes or comparisons and hence evidence for these is limited, with confidence intervals often encompassing clinically significant harm and benefit.
Authors' conclusions:
There is moderate-certainty evidence that ECs with nicotine increase quit rates compared to ECs without nicotine and compared to NRT. Evidence comparing nicotine EC with usual care/no treatment also suggests benefit, but is less certain. More studies are needed to confirm the degree of effect, particularly when using modern EC products. Confidence intervals were wide for data on AEs, SAEs and other safety markers. Overall incidence of SAEs was low across all study arms. We did not detect any clear evidence of harm from nicotine EC, but longest follow-up was two years and the overall number of studies was small. The main limitation of the evidence base remains imprecision due to the small number of RCTs, often with low event rates. Further RCTs are underway. To ensure the review continues to provide up-to-date information for decision-makers, this review is now a living systematic review. We will run searches monthly from December 2020, with the review updated as relevant new evidence becomes available. Please refer to the Cochrane Database of Systematic Reviews for the review's current status.
Introduction
PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.
Methods
This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N=179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8ppm, at the end of treatment; EOT).
Results
Combining varenicline and placebo arms, greater adherence (OR=1.011, 95% CI:1.00-1.02, p=0.051) and faster nicotine metabolism (OR=3.08, 95% CI:1.01-9.37, p=0.047) were related to higher quit rates. In separate models, adherence (OR=1.009, 95% CI:1.004-1.01, p<0.001) and nicotine metabolism rate (OR=2.04, 95% CI:1.19-3.49, p=0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ²[1]=2.80, p=0.09) and adherent (35% vs. 15%; χ²[1]=6.51, p=0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR<0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ²[1]=1.17, p=0.28) but, among fast metabolizers (NMR ≥0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ²[1]=4.43, p=0.04).
Conclusions
Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.
Background:
Whilst the pharmacological profiles and mechanisms of antidepressants are varied, there are common reasons why they might help people to stop smoking tobacco. Firstly, nicotine withdrawal may produce depressive symptoms and antidepressants may relieve these. Additionally, some antidepressants may have a specific effect on neural pathways or receptors that underlie nicotine addiction.
Objectives:
To assess the evidence for the efficacy, safety and tolerability of medications with antidepressant properties in assisting long-term tobacco smoking cessation in people who smoke cigarettes.
Search methods:
We searched the Cochrane Tobacco Addiction Specialized Register, which includes reports of trials indexed in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO, clinicaltrials.gov, the ICTRP, and other reviews and meeting abstracts, in May 2019.
Selection criteria:
We included randomized controlled trials (RCTs) that recruited smokers, and compared antidepressant medications with placebo or no treatment, an alternative pharmacotherapy, or the same medication used in a different way. We excluded trials with less than six months follow-up from efficacy analyses. We included trials with any follow-up length in safety analyses.
Data collection and analysis:
We extracted data and assessed risk of bias using standard Cochrane methods. We also used GRADE to assess the certainty of the evidence. The primary outcome measure was smoking cessation after at least six months follow-up, expressed as a risk ratio (RR) and 95% confidence intervals (CIs). We used the most rigorous definition of abstinence available in each trial, and biochemically validated rates if available. Where appropriate, we performed meta-analysis using a fixed-effect model. Similarly, we presented incidence of safety and tolerance outcomes, including adverse events (AEs), serious adverse events (SAEs), psychiatric AEs, seizures, overdoses, suicide attempts, death by suicide, all-cause mortality, and trial dropout due to drug, as RRs (95% CIs).
Main results:
We included 115 studies (33 new to this update) in this review; most recruited adult participants from the community or from smoking cessation clinics. We judged 28 of the studies to be at high risk of bias; however, restricting analyses only to studies at low or unclear risk did not change clinical interpretation of the results. There was high-certainty evidence that bupropion increased long-term smoking cessation rates (RR 1.64, 95% CI 1.52 to 1.77; I2 = 15%; 45 studies, 17,866 participants). There was insufficient evidence to establish whether participants taking bupropion were more likely to report SAEs compared to those taking placebo. Results were imprecise and CIs encompassed no difference (RR 1.16, 95% CI 0.90 to 1.48; I2 = 0%; 21 studies, 10,625 participants; moderate-certainty evidence, downgraded one level due to imprecision). We found high-certainty evidence that use of bupropion resulted in more trial dropouts due to adverse events of the drug than placebo (RR 1.37, 95% CI 1.21 to 1.56; I2 = 19%; 25 studies, 12,340 participants). Participants randomized to bupropion were also more likely to report psychiatric AEs compared with those randomized to placebo (RR 1.25, 95% CI 1.15 to 1.37; I2 = 15%; 6 studies, 4439 participants). We also looked at the safety and efficacy of bupropion when combined with other non-antidepressant smoking cessation therapies. There was insufficient evidence to establish whether combination bupropion and nicotine replacement therapy (NRT) resulted in superior quit rates to NRT alone (RR 1.19, 95% CI 0.94 to 1.51; I2 = 52%; 12 studies, 3487 participants), or whether combination bupropion and varenicline resulted in superior quit rates to varenicline alone (RR 1.21, 95% CI 0.95 to 1.55; I2 = 15%; 3 studies, 1057 participants). We judged the certainty of evidence to be low and moderate, respectively; in both cases due to imprecision, and also due to inconsistency in the former. Safety data were sparse for these comparisons, making it difficult to draw clear conclusions. A meta-analysis of six studies provided evidence that bupropion resulted in inferior smoking cessation rates to varenicline (RR 0.71, 95% CI 0.64 to 0.79; I2 = 0%; 6 studies, 6286 participants), whilst there was no evidence of a difference in efficacy between bupropion and NRT (RR 0.99, 95% CI 0.91 to 1.09; I2 = 18%; 10 studies, 8230 participants). We also found some evidence that nortriptyline aided smoking cessation when compared with placebo (RR 2.03, 95% CI 1.48 to 2.78; I2 = 16%; 6 studies, 975 participants), whilst there was insufficient evidence to determine whether bupropion or nortriptyline were more effective when compared with one another (RR 1.30 (favouring bupropion), 95% CI 0.93 to 1.82; I2 = 0%; 3 studies, 417 participants). There was no evidence that any of the other antidepressants tested (including St John's Wort, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs)) had a beneficial effect on smoking cessation. Findings were sparse and inconsistent as to whether antidepressants, primarily bupropion and nortriptyline, had a particular benefit for people with current or previous depression.
Authors' conclusions:
There is high-certainty evidence that bupropion can aid long-term smoking cessation. However, bupropion also increases the number of adverse events, including psychiatric AEs, and there is high-certainty evidence that people taking bupropion are more likely to discontinue treatment compared with placebo. However, there is no clear evidence to suggest whether people taking bupropion experience more or fewer SAEs than those taking placebo (moderate certainty). Nortriptyline also appears to have a beneficial effect on smoking quit rates relative to placebo. Evidence suggests that bupropion may be as successful as NRT and nortriptyline in helping people to quit smoking, but that it is less effective than varenicline. There is insufficient evidence to determine whether the other antidepressants tested, such as SSRIs, aid smoking cessation, and when looking at safety and tolerance outcomes, in most cases, paucity of data made it difficult to draw conclusions. Due to the high-certainty evidence, further studies investigating the efficacy of bupropion versus placebo are unlikely to change our interpretation of the effect, providing no clear justification for pursuing bupropion for smoking cessation over front-line smoking cessation aids already available. However, it is important that where studies of antidepressants for smoking cessation are carried out they measure and report safety and tolerability clearly.
Introduction:
The majority of women who smoke cigarettes report that concern about weight gain is a barrier to quitting. We developed an intervention incorporating distress tolerance, appetite awareness, and mindful eating skills to target concerns about post-cessation weight gain and emotional eating (DT-W). In the current study, we conducted a pilot randomized controlled trial of DT-W vs. a smoking health education (HE) intervention.
Methods:
Participants (N = 69 adult female, weight-concerned smokers) were recruited in cohorts of 4-11. Cohorts were randomized to DT-W or HE. DT-W and HE were matched on format (single individual session followed by eight group sessions), inclusion of cognitive-behavioral therapy for smoking cessation (CBT) content, and pharmacotherapy (nicotine patches). Follow-up assessments occurred at 1-, 3-, and 6-months post-treatment.
Results:
The recruitment goal was met; 61 of the 69 participants attended at least one group session. There were no significant differences between DT-W and HE in the number of group sessions attended (DT-W adjusted M = 5.09, HE adjusted M = 5.03, p = .92), ratings of treatment effectiveness or usefulness of skills, or retention at 6-month follow-up (79% in DT-W vs. 78% in HE) (ps > .05), but comprehension ratings were lower in DT-W than in HE (p = .02).
Conclusions:
Overall, these results suggest that the study procedures and interventions were feasible and acceptable, but changes to the DT-W intervention content to improve comprehension should be considered prior to conducting a fully-powered trial.
Our main objective was to demonstrate that, in smoker patients hospitalised for Chronic Obstructive Pulmonary Disease (COPD) exacerbation, early initiation of varenicline during 12 weeks, combined with an intensive counselling, is associated with a higher continuous abstainers rate (CAR) at one year as compared to intensive counselling alone. In this multicenter, prospective, double-blind, randomised study, 81 smoking COPD patients hospitalised for an acute exacerbation for at least 24 h were allocated to receive either varenicline (n = 42) or placebo (n = 39) for 12 weeks, in association with an intensive counselling in the 2 groups, and followed up for 40 weeks. The primary outcome was CAR at week 52. Secondary outcomes included CAR at week 12 and 26, partial abstinence rate (PAR) at week 12, 26 and 52, nicotinic substitute consumption and adverse events. At week 52, CAR was not different in placebo and varenicline groups (25.6%). At week 12, CAR was significantly higher in the varenicline group (50%) as compared to placebo group (27%) (p = 0.041). Nicotine consumption was significantly higher at week 52 in the placebo group (55.3%) as compared to the varenicline group (24.4%) (p = 0.005). There was no significant difference in PAR at week 12, 26 and 52; the frequency of adverse events was similar between the two groups. Among active smoker COPD patients with exacerbation, 12-week varenicline associated with intensive counselling for smoking cessation increased the rate of continuous abstainers as compared to placebo. However, benefit was not maintained after varenicline discontinuation.
Clinical Trials Registration: URL: http://www.controlled-trials.com. Unique identifier: NCT01694732
Background:
Taking regular exercise, whether cardiovascular-type exercise or resistance exercise, may help people to give up smoking, particularly by reducing cigarette withdrawal symptoms and cravings, and by helping to manage weight gain.
Objectives:
To determine the effectiveness of exercise-based interventions alone, or combined with a smoking cessation programme, for achieving long-term smoking cessation, compared with a smoking cessation intervention alone or other non-exercise intervention.
Search methods:
We searched the Cochrane Tobacco Addiction Group Specialised Register for studies, using the term 'exercise' or 'physical activity' in the title, abstract or keywords. The date of the most recent search was May 2019.
Selection criteria:
We included randomised controlled trials that compared an exercise programme alone, or an exercise programme as an adjunct to a cessation programme, with a cessation programme alone or another non-exercise control group. Trials were required to recruit smokers wishing to quit or recent quitters, to assess abstinence as an outcome and have follow-up of at least six months.
Data collection and analysis:
We followed standard Cochrane methods. Smoking cessation was measured after at least six months, using the most rigorous definition available, on an intention-to-treat basis. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for smoking cessation for each study, where possible. We grouped eligible studies according to the type of comparison, as either smoking cessation or relapse prevention. We carried out meta-analyses where appropriate, using Mantel-Haenszel random-effects models.
Main results:
We identified 24 eligible trials with a total of 7279 adult participants randomised. Two studies focused on relapse prevention among smokers who had recently stopped smoking, and the remaining 22 studies were concerned with smoking cessation for smokers who wished to quit. Eleven studies were with women only and one with men only. Most studies recruited fairly inactive people. Most of the trials employed supervised, group-based cardiovascular-type exercise supplemented by a home-based exercise programme and combined with a multi-session cognitive behavioural smoking cessation programme. The comparator in most cases was a multi-session cognitive behavioural smoking cessation programme alone. Overall, we judged two studies to be at low risk of bias, 11 at high risk of bias, and 11 at unclear risk of bias. Among the 21 studies analysed, we found low-certainty evidence, limited by potential publication bias and by imprecision, comparing the effect of exercise plus smoking cessation support with smoking cessation support alone on smoking cessation outcomes (RR 1.08, 95% CI 0.96 to 1.22; I2 = 0%; 6607 participants). We excluded one study from this analysis as smoking abstinence rates for the study groups were not reported. There was no evidence of subgroup differences according to the type of exercise promoted; the subgroups considered were: cardiovascular-type exercise alone (17 studies), resistance training alone (one study), combined cardiovascular-type and resistance exercise (one study) and type of exercise not specified (two studies). The results were not significantly altered when we excluded trials with high risk of bias, or those with special populations, or those where smoking cessation intervention support was not matched between the intervention and control arms. Among the two relapse prevention studies, we found very low-certainty evidence, limited by risk of bias and imprecision, that adding exercise to relapse prevention did not improve long-term abstinence compared with relapse prevention alone (RR 0.98, 95% CI 0.65 to 1.47; I2 = 0%; 453 participants).
Authors' conclusions:
There is no evidence that adding exercise to smoking cessation support improves abstinence compared with support alone, but the evidence is insufficient to assess whether there is a modest benefit. Estimates of treatment effect were of low or very low certainty, because of concerns about bias in the trials, imprecision and publication bias. Consequently, future trials may change these conclusions.
Introduction:
The co-use of cannabis and alcohol among tobacco-using youth is common. Alcohol co-use is associated with worse tobacco cessation outcomes, but results are mixed regarding the impact of cannabis on tobacco outcomes and if co-use leads to increased use of non-treated substances. This secondary analysis from a youth smoking cessation trial aimed to (1) evaluate the impact of cannabis or alcohol co-use on smoking cessation, (2) examine changes in co-use during the trial, and (3) explore secondary effects of varenicline on co-use.
Methods:
The parent study was a 12-week, randomized clinical trial of varenicline for smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White). Daily cigarette, cannabis, and alcohol use data were collected via daily diaries during treatment and Timeline Follow-back for 14 weeks post-treatment.
Results:
Baseline cannabis co-users (68%) had double the odds of continued cigarette smoking throughout the trial compared with noncannabis users, which was pronounced in males and frequent cannabis users. Continued smoking during treatment was associated with higher probability of concurrent cannabis use. Baseline alcohol co-users (80%) did not have worse smoking outcomes compared with nonalcohol users, but continued smoking was associated with higher probability of concurrent drinking. Varenicline did not affect co-use.
Conclusions:
Inconsistent with prior literature, results showed that alcohol co-users did not differ in smoking cessation, whereas cannabis co-users had poorer cessation outcomes. Youth tobacco treatment would benefit from added focus on substance co-use, particularly cannabis, but may need to be tailored appropriately to promote cessation.
Implications:
Among youth cigarette smokers enrolled in a pharmacotherapy evaluation clinical trial, alcohol and/or cannabis co-use was prevalent. The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation. Reductions in smoking were accompanied by concurrent reductions in alcohol or cannabis use. Substance co-use does not appear to affect all youth smokers in the same manner and treatment strategies may need to be tailored appropriately for those with lower odds of smoking cessation.
Importance
Cigarette smoking is the leading cause of preventable morbidity and mortality in the United States and worldwide, and most tobacco users begin smoking in adolescence. Although advances have yielded efficacious pharmacotherapies to complement smoking cessation counseling in adults, far less progress has been made in addressing tobacco use in adolescence.
Objective
To evaluate the efficacy and safety of varenicline tartrate for smoking cessation in adolescents and young adults.
Design, Setting, and Participants
This 2-group randomized, placebo-controlled, double-blind intention-to-treat clinical trial enrolled a volunteer sample of treatment-seeking adolescent and young adult cigarette smokers (n = 157) aged 14 to 21 years at an outpatient clinical site in Charleston, South Carolina, from August 15, 2012, to October 20, 2017. Follow-up was completed on January 25, 2018. Data were analyzed from March 19, 2018, to August 11, 2018, with further revisions completed April 10, 2019.
Interventions
Participants were randomized in a 1:1 ratio to a 12-week course of varenicline (n = 77) or placebo (n = 80). All participants received weekly smoking cessation counseling.
Main Outcomes and Measures
The preselected primary efficacy outcome was urine cotinine level–confirmed 7-day abstinence at the end of treatment. Secondary efficacy outcomes included weekly abstinence throughout active treatment, abstinence at posttreatment follow-up visits, and time to first 7-day abstinence. The primary safety outcome was the frequency of treatment-emergent adverse events.
Results
A total of 157 participants were enrolled (94 male [59.9%]; mean [SD] age, 19.1 [1.5] years). The varenicline and placebo groups did not differ in the primary outcome of cotinine-confirmed self-reported 7-day abstinence at the end of treatment (varenicline group, 4 of 45 [8.9%]; placebo group, 4 of 45 [8.9%]; risk ratio [RR], 0.97; 95% CI, 0.29-2.99; P = .96). However, among secondary outcomes, the varenicline group achieved self-reported earlier abstinence of at least 7 days (hazard ratio, 1.91; 95% CI, 1.12-3.27) and demonstrated higher rates of self-reported weekly abstinence during the full course of treatment (RR, 1.81; 95% CI, 1.09-2.99; P = .02) and at posttreatment follow-up (RR, 1.82; 95% CI, 1.01-3.28; P = .02). Study medication was generally well tolerated, and treatment-emergent adverse events did not differ between groups (any adverse events, 55 [71.4%] in the varenicline group vs 60 [75.0%] in the placebo group; RR, 0.95; 95% CI, 0.79-1.15; P = .61).
Conclusions and Relevance
When added to weekly cessation counseling for adolescent cigarette smokers, varenicline, compared with placebo, was well tolerated but did not improve end-of-treatment abstinence. However, varenicline may hasten abstinence and yield improvements in posttreatment abstinence outcomes.
Trial Registration
ClinicalTrials.gov identifier: NCT01509547
Introduction:
This study explored the efficacy of combination lorcaserin and nicotine patch for smoking cessation treatment and prevention of postsmoking cessation weight gain.
Methods:
We conducted a trial in which 61 adult daily smokers were asked to quit smoking using a combination of lorcaserin and nicotine patch. During the first 2 weeks of treatment prior to the quit day, participants were randomized to receive either lorcaserin (10 mg twice daily) plus nicotine patch (21 mg) or placebo plus nicotine patch (21 mg). Following this 2-week period, participants received both medications for 12 weeks. Outcomes included 4-week continuous smoking abstinence at the end of treatment (weeks 7-10 postquit attempt), weight change, ad libitum smoking, withdrawal symptoms, and ratings of cigarette reward.
Results:
Biochemically confirmed continuous smoking abstinence from 7 to 10 weeks postquit attempt was 31.1% (90% confidence interval, 21.4%-40.8%). Participants who quit smoking showed no weight gain; in fact, mean weight change was minus 0.16 kg (SD = 3.27) over the study period. There was an unexpected but strong association (p = .006) between a decrease in sensory enjoyment of smoking and successful quit outcome on this regimen. During the prequit randomization period, lorcaserin versus placebo reduced the impact of smoking to relieve craving for cigarettes as well as the sensory enjoyment of smoking (p = .005). Adherence and tolerability to lorcaserin and nicotine patch was good.
Conclusions:
The combination of lorcaserin and nicotine patch was well tolerated, associated with a relatively high smoking abstinence rate, and effectively prevented weight gain associated with quitting smoking.
Implications:
This report provides an important contribution to the literature because it details evidence of a medication combination-lorcaserin and nicotine-that is effective for smoking cessation and for ameliorating weight gain associated with smoking cessation. For many smokers, postcessation weight gain is a major obstacle to quitting, and this medication combination provides a suitable treatment option for these smokers.
Clinical trial registration:
NCT02906644.
Background:
Postmenopausal smokers have difficulty quitting smoking and experience considerable weight gain with smoking cessation. We examined whether adjunctive smoking treatment with exercise, compared to a relaxation control condition, could improve cigarette abstinence, decrease cigarettes smoked per day (CPD) and ameliorate changes in body mass index (BMI) in postmenopausal smokers.
Methods:
Women (N=301) signed informed consent and were randomized to treatment at two sites (Universities of Connecticut and Minnesota). We randomized groups of participants to a comprehensive group treatment program that included 12 weeks of varenicline and either a moderate exercise or relaxation component for 6 months. Participants were followed for a year after medication treatment.
Results:
Overall, 17.3% of patients reported carbon monoxide-verified continuous abstinence for the 9-12-week period, and 11.6% reported prolonged abstinence at one year, with no significant differences between treatment conditions. CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment. The Exercise group reported smoking fewer CPD over time, and that advantage widened over time. In terms of BMI, significant effects for time in weeks, and for the interaction of Week X Treatment condition, reflected gradually increasing BMI in these women over time, but with the increase in BMI slower in the Exercise condition.
Conclusions:
Exercise, compared to relaxation, was associated with a reduced BMI and CPD in postmenopausal women, but did not increase end of treatment or prolonged abstinence. Further research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.
Implications:
This study adds to the literature on the effectiveness of a moderate exercise intervention compared to a relaxation control condition as an adjunctive treatment for smoking cessation in postmenopausal women. Our exercise program did not increase end of treatment or prolonged abstinence rates in postmenopausal women; however, there was a beneficial effect on smoking reduction and reduced body mass index. Additional research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.
Background:
Combination nicotine replacement therapy shows additive cessation benefits. We aimed to find out the effectiveness of combining nicotine patches with an e-cigarette (with and without nicotine) on six-month smoking abstinence.
Methods:
We did a pragmatic, three-arm, parallel-group trial in New Zealand in adult smokers who were e-cigarette naive and motivated to quit smoking. Participants were recruited from the general population using national media advertising. Participants were randomly assigned (1:4:4), with the use of stratified block randomisation, to receive 14 weeks (2 weeks before the agreed quit date) of 21 mg, 24h nicotine patches, patches plus an 18 mg/L nicotine e-cigarette, or patches plus a nicotine-free e-cigarette. We advised participants to use one patch daily, with e-cigarette use as and when necessary or desired. Participants and researchers were masked to e-liquid nicotine content. We offered 6 weeks of telephone-delivered behavioural support. The primary outcome was exhaled carbon monoxide (CO)-verified continuous smoking abstinence 6 months after the agreed quit date. Primary analysis was by intention to treat, with sensitivity analysis by per protocol, treatment adherence, varying CO cutoffs, and complete case analysis. This paper presents the main analyses and is registered with ClinicalTrials.gov, NCT02521662.
Findings:
Between March 17, 2016 and Nov 30, 2017, 1124 people were assigned to nicotine patches (patches only group, n=125), patches plus a nicotine e-cigarette (patches plus nicotine e-cigarette group, n=500), or patches plus a nicotine-free e-cigarette (patches plus nicotine-free e-cigarette group, n=499). 62 (50%) of 125 participants in the patches only group withdrew or were lost to follow-up by 6 months compared with 161 (32%) of 500 in the patches plus nicotine e-cigarette group and 162 (33%) of 499 in the patches plus nicotine-free e-cigarette group. 35 (7%) participants in the patches plus nicotine e-cigarette group had CO-verified continuous abstinence at 6 months compared with 20 (4%) in the patches plus nicotine-free e-cigarette group (risk difference [RD] 2·99 [95% CI 0·17-5·81]), and three (2%) people in the patches only group (RD 4·60 [1·11-8·09]). 18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group. In the patches plus nicotine e-cigarette group, two life-threatening serious adverse events were reported (two separate heart attacks in the one participant). In the patches plus nicotine-free e-cigarette group, one death occurred (accidental drug overdose) and one life-threatening serious adverse event (heart attack). No significant between-group differences were noted for serious adverse events, and none were treatment-related.
Interpretation:
Combining reduced-harm nicotine products, such as nicotine patches with a nicotine e-cigarette, can lead to a modest improvement in smoking cessation over and above that obtained from using patches plus a nicotine-free e-cigarette (or patches alone), with no indication of any serious harm in the short-term. Future e-cigarette trials should focus on their use alone or in combination with usual smoking cessation support, given issues with differential loss to follow-up and withdrawal if a usual care group is used as a comparator.
Funding:
Health Research Council of New Zealand.
Background:
Smoking cessation may help the current smokers to reduce cancer risk. However, weight gain following smoking cessation may attenuate the protective association of cessation with cancer.
Patients and methods:
Our study included 1,278,794 men who were aged 20-39 years and underwent two consecutive health examinations by the National Health Insurance Service, without previous diagnosis of cancer. Participants were categorized into continual smokers, quitters with different degree of body weight change, and never smokers based on the biennial national health screening program (2002-2003 and 2004-2005) and were followed from January 1, 2006 to December 31, 2015. Cox proportional hazard models and restricted cubic spline model was used to evaluate the association of post-cessation weight change and cancer risk after adjustment for potential confounders.
Results:
During the 10 years of follow-up, the analyses included 1,278,794 men with 21,494 cancer incidences. Compared to continual smokers, quitters without weight gain of 2.0 kg had significantly lower risk of obesity-related cancer (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.79-0.97), smoking-related cancer (HR, 0.90; 95% CI, 0.83 to 0.98), and gastrointestinal cancer (HR, 89; 95% CI, 0.80 to 0.98). Weight gain among quitters attenuated the risk reduction of cancer compared to continual smoking. Among quitters, weight gain up to 5.0 kg with smoking cessation showed protective association with cancer risk among quitters without weight gain.
Conclusion:
Excessive weight gain with smoking cessation among quitters was not associated with reduced risk of several cancer types. This association should be taken into account when recommending smoking cessation to prevent cancer.
Background:
Nicotine replacement therapy (NRT) aims to replace nicotine from cigarettes to ease the transition from cigarette smoking to abstinence. It works by reducing the intensity of craving and withdrawal symptoms. Although there is clear evidence that NRT used after smoking cessation is effective, it is unclear whether higher doses, longer durations of treatment, or using NRT before cessation add to its effectiveness.
Objectives:
To determine the effectiveness and safety of different forms, deliveries, doses, durations and schedules of NRT, for achieving long-term smoking cessation, compared to one another.
Search methods:
We searched the Cochrane Tobacco Addiction Group trials register, and trial registries for papers mentioning NRT in the title, abstract or keywords. Date of most recent search: April 2018.
Selection criteria:
Randomized trials in people motivated to quit, comparing one type of NRT use with another. We excluded trials that did not assess cessation as an outcome, with follow-up less than six months, and with additional intervention components not matched between arms. Trials comparing NRT to control, and trials comparing NRT to other pharmacotherapies, are covered elsewhere.
Data collection and analysis:
We followed standard Cochrane methods. Smoking abstinence was measured after at least six months, using the most rigorous definition available. We extracted data on cardiac adverse events (AEs), serious adverse events (SAEs), and study withdrawals due to treatment. We calculated the risk ratio (RR) and the 95% confidence interval (CI) for each outcome for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate, using a Mantel-Haenszel fixed-effect model.
Main results:
We identified 63 trials with 41,509 participants. Most recruited adults either from the community or from healthcare clinics. People enrolled in the studies typically smoked at least 15 cigarettes a day. We judged 24 of the 63 studies to be at high risk of bias, but restricting the analysis only to those studies at low or unclear risk of bias did not significantly alter results, apart from in the case of the preloading comparison. There is high-certainty evidence that combination NRT (fast-acting form + patch) results in higher long-term quit rates than single form (RR 1.25, 95% CI 1.15 to 1.36, 14 studies, 11,356 participants; I2 = 4%). Moderate-certainty evidence, limited by imprecision, indicates that 42/44 mg are as effective as 21/22 mg (24-hour) patches (RR 1.09, 95% CI 0.93 to 1.29, 5 studies, 1655 participants; I2 = 38%), and that 21 mg are more effective than 14 mg (24-hour) patches (RR 1.48, 95% CI 1.06 to 2.08, 1 study, 537 participants). Moderate-certainty evidence (again limited by imprecision) also suggests a benefit of 25 mg over 15 mg (16-hour) patches, but the lower limit of the CI encompassed no difference (RR 1.19, 95% CI 1.00 to 1.41, 3 studies, 3446 participants; I2 = 0%). Five studies comparing 4 mg gum to 2 mg gum found a benefit of the higher dose (RR 1.43, 95% CI 1.12 to 1.83, 5 studies, 856 participants; I2 = 63%); however, results of a subgroup analysis suggest that only smokers who are highly dependent may benefit. Nine studies tested the effect of using NRT prior to quit day (preloading) in comparison to using it from quit day onward; there was moderate-certainty evidence, limited by risk of bias, of a favourable effect of preloading on abstinence (RR 1.25, 95% CI 1.08 to 1.44, 9 studies, 4395 participants; I2 = 0%). High-certainty evidence from eight studies suggests that using either a form of fast-acting NRT or a nicotine patch results in similar long-term quit rates (RR 0.90, 95% CI 0.77 to 1.05, 8 studies, 3319 participants; I2 = 0%). We found no evidence of an effect of duration of nicotine patch use (low-certainty evidence); 16-hour versus 24-hour daily patch use; duration of combination NRT use (low- and very low-certainty evidence); tapering of patch dose versus abrupt patch cessation; fast-acting NRT type (very low-certainty evidence); duration of nicotine gum use; ad lib versus fixed dosing of fast-acting NRT; free versus purchased NRT; length of provision of free NRT; ceasing versus continuing patch use on lapse; and participant- versus clinician-selected NRT. However, in most cases these findings are based on very low- or low-certainty evidence, and are the findings from single studies.AEs, SAEs and withdrawals due to treatment were all measured variably and infrequently across studies, resulting in low- or very low-certainty evidence for all comparisons. Most comparisons found no evidence of an effect on cardiac AEs, SAEs or withdrawals. Rates of these were low overall. Significantly more withdrawals due to treatment were reported in participants using nasal spray in comparison to patch in one trial (RR 3.47, 95% CI 1.15 to 10.46, 922 participants; very low certainty) and in participants using 42/44 mg patches in comparison to 21/22 mg patches across two trials (RR 4.99, 95% CI 1.60 to 15.50, 2 studies, 544 participants; I2 = 0%; low certainty).
Authors' conclusions:
There is high-certainty evidence that using combination NRT versus single-form NRT, and 4 mg versus 2 mg nicotine gum, can increase the chances of successfully stopping smoking. For patch dose comparisons, evidence was of moderate certainty, due to imprecision. Twenty-one mg patches resulted in higher quit rates than 14 mg (24-hour) patches, and using 25 mg patches resulted in higher quit rates than using 15 mg (16-hour) patches, although in the latter case the CI included one. There was no clear evidence of superiority for 42/44 mg over 21/22 mg (24-hour) patches. Using a fast-acting form of NRT, such as gum or lozenge, resulted in similar quit rates to nicotine patches. There is moderate-certainty evidence that using NRT prior to quitting may improve quit rates versus using it from quit date only; however, further research is needed to ensure the robustness of this finding. Evidence for the comparative safety and tolerability of different types of NRT use is of low and very low certainty. New studies should ensure that AEs, SAEs and withdrawals due to treatment are both measured and reported.
Background
Pre-treatment factors that increase smokers’ risk of experiencing neuropsychiatric adverse events (NPSAEs) when quitting smoking are unknown.
Objective
To identify baseline smoker characteristics beyond the history of mental illness that predict which participants were more likely to experience moderate to severe NPSAEs in EAGLES.
Design
A prospective correlational cohort study in the context of a multinational, multicenter, double-blind, randomized trial.
Participants
Smokers without (N = 3984; NPC)/with (N = 4050; PC) histories of, or current clinically stable, psychiatric disorders including mood (N = 2882; 71%), anxiety (N = 782; 19%), and psychotic (N = 386; 10%) disorders.
Interventions
Bupropion, 150 mg twice daily, or varenicline, 1 mg twice daily, versus active control (nicotine patch, 21 mg/day with taper) and placebo for 12 weeks with 12-week non-treatment follow-up.
Main Measures
Primary safety outcome was the incidence of a composite measure of moderate/severe NPSAEs. Associations among baseline demographic/clinical characteristics and the primary safety endpoint were analyzed post hoc via generalized linear regression.
Key Results
The incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%). Three baseline characteristics predicted increased risk for experiencing clinically significant NPSAEs when quitting regardless of carrying a psychiatric diagnosis: current symptoms of anxiety (for every ~ 4-unit increase in HADS anxiety score, the absolute risk of occurrence of the NPSAE endpoint increased by 1% in both PC and NPC); prior history of suicidal ideation and/or behavior (PC, 4.4% increase; P = 0.001; NPC, 4.1% increase; P = 0.02), and being of White race (versus Black: PC, 2.9% ± 0.9 [SE] increase; P = 0.002; and NPC, 3.4% ± 0.8 [SE] increase; P = 0.001). Among smokers with psychiatric disorders, younger age, female sex, history of substance use disorders, and proxy measures of nicotine dependence or psychiatric illness severity also predicted greater risk. There were no significant interactions between these characteristics and treatment. Smokers with unstable psychiatric disorders or with current, active substance abuse were excluded from the study.
Conclusions
Irrespective of cessation pharmacotherapy use, smokers attempting to quit were more likely to experience moderate to severe NPSAEs if they reported current anxiety or prior suicidal ideation at baseline and were White. In smokers with a psychiatric history, female sex, younger age, and greater severity of nicotine dependence were also predictive.
Trial Registration
ClinicalTrials.gov Identifier: NCT01456936
Based on evidence that the actions of nicotine in humans are likely related to a combination of agonist and antagonist effects and that effective treatments for nicotine dependence may be developed using combinations of nicotinic receptor agonism and antagonism, there has been considerable interest in the development of nicotinic receptor partial agonists. Varenicline tartarate is the first nicotinic receptor partial agonist to be developed for use as a pharmacological aid for smoking cessation. The results of phase II and III trials are very promising, and evidence suggests that this agent is safe and efficacious in both abstinence initiation and relapse-prevention trials and that it may have superior efficacy to bupropion SR. The authors discuss the potential for this agent, which when approved will clearly add to the repertoire of available medications for the treatment of nicotine dependence.
While smoking cessation leads to significant improvements in both mortality and morbidity, post-cessation weight gain partially attenuates this benefit. Even though post-cessation weight gain is small (4.7 kg on average), it is a stated reason to delay cessation attempts and is associated with smoking relapse. Fit & Quit is a randomized, controlled efficacy trial that aims to examine the ability of a weight stability intervention and a weight loss intervention to reduce post-cessation weight gain. For this purpose, Fit & Quit will randomize participants to
three conditions: (a) Small Changes, a weight gain prevention intervention; (b) Look AHEAD Intensive Lifestyle Intervention; and (c) a lower-intensity bibliotherapy intervention. All conditions will receive a highly efficacious behavioral (i.e., rate reduction skills, motivational interviewing) and pharmacological (i.e., varenicline) smoking cessation program. A total of 400 participants will be recruited and randomized to the three interventions. Participants will be recruited in waves, with 10 waves of approximately 40 participants per wave. The primary outcomes of this study include post-cessation weight gain and cessation status at 12-month follow-up. Fit & Quit will integrate and adapt the strongest evidence-based interventions available for weight management and
smoking cessation. Fit & Quit is highly innovative in the areas of the target population, study design, and use of technology. For these reasons, we expect that Fit & Quit will make a significant public health contribution to curtailing the important cessation barrier of post-cessation weight gain.
Background
Whether weight gain after smoking cessation attenuates the health benefits of quitting is unclear.
Methods
In three cohort studies involving men and women in the United States, we identified those who had reported quitting smoking and we prospectively assessed changes in smoking status and body weight. We estimated risks of type 2 diabetes, death from cardiovascular disease, and death from any cause among those who had reported quitting smoking, according to weight changes after smoking cessation.
Results
The risk of type 2 diabetes was higher among recent quitters (2 to 6 years since smoking cessation) than among current smokers (hazard ratio, 1.22; 95% confidence interval [CI], 1.12 to 1.32). The risk peaked 5 to 7 years after quitting and then gradually decreased. The temporary increase in the risk of type 2 diabetes was directly proportional to weight gain, and the risk was not increased among quitters without weight gain (P<0.001 for interaction). In contrast, quitters did not have a temporary increase in mortality, regardless of weight change after quitting. As compared with current smokers, the hazard ratios for death from cardiovascular disease were 0.69 (95% CI, 0.54 to 0.88) among recent quitters without weight gain, 0.47 (95% CI, 0.35 to 0.63) among those with weight gain of 0.1 to 5.0 kg, 0.25 (95% CI, 0.15 to 0.42) among those with weight gain of 5.1 to 10.0 kg, 0.33 (95% CI, 0.18 to 0.60) among those with weight gain of more than 10.0 kg, and 0.50 (95% CI, 0.46 to 0.55) among longer-term quitters (>6 years since smoking cessation). Similar associations were observed for death from any cause.
Conclusions
Smoking cessation that was accompanied by substantial weight gain was associated with an increased short-term risk of type 2 diabetes but did not mitigate the benefits of quitting smoking on reducing cardiovascular and all-cause mortality. (Funded by the National Institutes of Health.)
Introduction:
Post-cessation weight gain contributes to smoking relapse, especially for women. Furthermore, excess weight in the form of android or visceral fat is associated with metabolic health problems. For this study, a secondary analysis was conducted in 2015 to determine whether quitting status, achieved through a 14 week supervised exercise-aided nicotine replacement therapy (NRT) cessation program [Getting Physical on Cigarette Trial-2009 to 2013; Prapavessis, et al., 2016], affects anthropometric and body composition parameters in female smokers (N = 413, M age = 42.39 years).
Methods:
Anthropometric (weight and BMI) and body composition (% total body fat, % android fat, lean mass and visceral fat) indices were assessed at baseline and end of treatment. Smoking status was confirmed weekly from expired breath carbon monoxide. Adherence to exercise and NRT patch was calculated from the number of exercise sessions attended and patches worn to the number of exercise sessions offered and patches supplied, respectively.
Results:
Factorial (smoking status) ANCOVAs controlling for baseline anthropometric and body composition parameters as well as adherence to exercise and NRT revealed significant differences in weight (p = .033; ɳp2 = 0.017) and BMI (p = .020; ɳp2 = 0.020) at week 14. This equated to abstainers weighing 1.26 kg more and having a 0.52 higher BMI than smokers. No significant differences were found for any of the body composition parameters at week 14 (ɳp2 range from 0.001-0.007).
Conclusions:
Abstainers gain modest weight compared to smokers. This weight gain is related to increases in lean mass and not total, android, or visceral fat.
Background:
Nicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence.
Objectives:
To determine the effectiveness and safety of nicotine replacement therapy (NRT), including gum, transdermal patch, intranasal spray and inhaled and oral preparations, for achieving long-term smoking cessation, compared to placebo or 'no NRT' interventions.
Search methods:
We searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of nicotine replacement therapy in the title, abstract or keywords. Date of most recent search is July 2017.
Selection criteria:
Randomized trials in people motivated to quit which compared NRT to placebo or to no treatment. We excluded trials that did not report cessation rates, and those with follow-up of less than six months, except for those in pregnancy (where less than six months, these were excluded from the main analysis). We recorded adverse events from included and excluded studies that compared NRT with placebo. Studies comparing different types, durations, and doses of NRT, and studies comparing NRT to other pharmacotherapies, are covered in separate reviews.
Data collection and analysis:
Screening, data extraction and 'Risk of bias' assessment followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model.
Main results:
We identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for nicotine nasal spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. A subset of six trials conducted in pregnant women found a statistically significant benefit of NRT on abstinence close to the time of delivery (RR 1.32, 95% CI 1.04 to 1.69; 2129 participants); in the four trials that followed up participants post-partum the result was no longer statistically significant (RR 1.29, 95% CI 0.90 to 1.86; 1675 participants). Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare.
Authors' conclusions:
There is high-quality evidence that all of the licensed forms of NRT (gum, transdermal patch, nasal spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non-ischaemic chest pain and palpitations.
Importance
Quitting smoking is enhanced by the use of pharmacotherapies, but concerns have been raised regarding the cardiovascular safety of such medications.
Objective
To compare the relative cardiovascular safety risk of smoking cessation treatments.
Design, Setting, and Participants
A double-blind, randomized, triple-dummy, placebo- and active-controlled trial (Evaluating Adverse Events in a Global Smoking Cessation Study [EAGLES]) and its nontreatment extension trial was conducted at 140 multinational centers. Smokers, with or without established psychiatric diagnoses, who received at least 1 dose of study medication (n = 8058), as well as a subset of those who completed 12 weeks of treatment plus 12 weeks of follow up and agreed to be followed up for an additional 28 weeks (n = 4595), were included.
Interventions
Varenicline, 1 mg twice daily; bupropion hydrochloride, 150 mg twice daily; and nicotine replacement therapy, 21-mg/d patch with tapering.
Main Outcomes and Measures
The primary end point was the time to development of a major adverse cardiovascular event (MACE: cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) during treatment; secondary end points were the occurrence of MACE and other pertinent cardiovascular events (MACE+: MACE or new-onset or worsening peripheral vascular disease requiring intervention, coronary revascularization, or hospitalization for unstable angina).
Results
Of the 8058 participants, 3553 (44.1%) were male (mean [SD] age, 46.5 [12.3] years). The incidence of cardiovascular events during treatment and follow-up was low (<0.5% for MACE; <0.8% for MACE+) and did not differ significantly by treatment. No significant treatment differences were observed in time to cardiovascular events, blood pressure, or heart rate. There was no significant difference in time to onset of MACE for either varenicline or bupropion treatment vs placebo (varenicline: hazard ratio, 0.29; 95% CI, 0.05-1.68 and bupropion: hazard ratio, 0.50; 95% CI, 0.10-2.50).
Conclusions and Relevance
No evidence that the use of smoking cessation pharmacotherapies increased the risk of serious cardiovascular adverse events during or after treatment was observed. The findings of EAGLES and its extension trial provide further evidence that smoking cessation medications do not increase the risk of serious cardiovascular events in the general population of smokers.
Trial Registration
clinicaltrials.gov Identifier: NCT01574703
Background:
Patients who continue to smoke after acute coronary syndrome are at increased risk of reinfarction and death. We previously found use of varenicline to increase abstinence 24 weeks after acute coronary syndrome; here we report results through 52 weeks.
Methods:
The EVITA trial was a multicentre, double-blind, randomized, placebo-controlled trial of varenicline for smoking cessation in patients admitted to hospital with acute coronary syndrome. Participants were randomly assigned (1:1) to receive varenicline or placebo for 12 weeks, in conjunction with low-intensity counselling. Smoking abstinence was assessed via 7-day recall, with biochemical validation using exhaled carbon monoxide. Participants lost to follow-up or withdrawn were assumed to have returned to smoking.
Results:
Among the 302 participants, abstinence declined over the course of the trial, with 34.4% abstinent 52 weeks after acute coronary syndrome. Compared with placebo, point estimates suggest use of varenicline increased point-prevalence abstinence (39.9% v. 29.1%, difference 10.7%, 95% confidence interval [CI] 0.01% to 21.44%; number needed to treat 10), continuous abstinence (31.1% v. 21.2%, difference 9.9%, 95% CI -0.01% to 19.8%) and reduction in daily cigarette smoking by 50% or greater (57.8% v. 49.7%, difference 8.1%, 95% CI -3.1% to 19.4%). Varenicline and placebo groups had similar occurrence of serious adverse events (24.5% v. 21.9%, risk difference 2.7%, 95% CI -7.3% to 12.6%) and major adverse cardiovascular events (8.6% v. 9.3%, risk difference -0.7%, 95% CI -7.8% to 6.5%).
Interpretation:
Varenicline was efficacious for smoking cessation in this high-risk patient population. However, 60% of patients who received treatment with varenicline still returned to smoking.Trial registration:ClinicalTrials.gov, no. NCT00794573.
Background:
Tobacco smoking is common in people living with HIV, but high-quality evidence on interventions for smoking cessation is not available in this population. We aimed to assess the efficacy and safety of varenicline with counselling to aid smoking cessation in people living with HIV.
Methods:
The ANRS 144 Inter-ACTIV randomised, parallel, double-blind, multicentre, placebo-controlled phase 3 trial was done at 30 clinical hospital sites in France. People living with HIV who had smoked at least ten cigarettes per day for 1 year or longer, were motivated to stop smoking, were not dependent on another psychoactive substance, and had no history of depression or suicide attempt were eligible. Using a computer-generated randomisation sequence, we allocated (1:1) the patients to receive either varenicline titrated to two 0·5 mg doses twice daily or placebo twice daily for 12 weeks, plus face-to-face counselling. Patients and investigators were masked to treatment group allocation. Patients who were not abstinent at week 24 were offered open-label varenicline for 12 additional weeks. The primary outcome was the proportion of smokers continuously abstinent from week 9 to week 48. Smoking status was confirmed by carbon monoxide in exhaled air. Primary analyses were done in both the intention-to-treat (ITT) population and modified ITT (mITT) population, which comprised all patients who took at least one tablet of their assigned study treatment. The safety analyses were done in the mITT population. The trial is registered at ClinicalTrials.gov, number NCT00918307. The trial status is complete.
Findings:
From Oct 26, 2009, to Dec 20, 2012, of 303 patients assessed for eligibility, 248 patients were randomly assigned to the varenicline group (n=123) or the placebo group (n=125). After randomisation, one participant initially assigned to the placebo group was excluded from the ITT analysis for a regulatory reason (no French health-care coverage). 102 patients in the varenicline group and 111 patients in the placebo group received at least one dose of their assigned treatment and were included in the mITT analysis. In the ITT analysis, varenicline was associated with a higher proportion of patients achieving continuous abstinence over the study period (week 9-48): 18 (15%, 95% CI 8-21) of 123 in the varenicline group versus eight (6%, 2-11) of 124 in the placebo group, adjusted odds ratio (OR) 2·5 (95% CI 1·0-6·1; p=0·041). In the mITT analysis, varenicline was also associated with higher continuous abstinence: 18 (18%, 95% CI 10-25) of 102 versus eight (7%, 2-12) of 111 in the placebo group (adjusted OR 2·7, 95% CI 1·1-6·5; p=0·029). The incidence of depression was 2·4 per 100 person-years (95% CI 0·6-9·5; two [2%] of 102) in the varenicline group and 12·4 per 100 person-years (95% CI 6·9-22·5; 11 [10%] of 111) in the placebo group. 14 (7%) of 213 participants had 18 cardiovascular events: six (6%) of 102 people in the varenicline group and eight (7%) of 111 people in the placebo group.
Interpretation:
Varenicline is safe and efficacious for smoking cessation in people living with HIV and should be recommended as the standard of care.
Funding:
The French National Institute for Health and Medical Research (INSERM)-French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Pfizer.
Objective:
To evaluate whether a behavioral weight management program combined with a smoking cessation program delivered via interactive technology could prevent postcessation weight gain.
Methods:
Three hundred and thirty young adult smokers, age 18 to 35 years, were randomized to a smoking cessation program alone (comparison group), which included behavioral counseling and nicotine replacement, or to a behavioral weight management program adapted from the Look AHEAD trial plus the same smoking cessation program (intervention group).
Results:
The Treating Adult Smokers at Risk for Weight Gain with Interactive Technology study randomized 164 participants to the comparison group and 166 participants to the intervention group. On average, the participants gained 0.91 kg after 24 months in the trial (comparison group + 1.45 kg and intervention group + 0.32; P = 0.157). The only variable systematically affecting weight change over time was smoking abstinence, in which those who were abstinent, on average, gained 0.14 kg more per month compared with those who continued to smoke (P < 0.001). In exploratory analyses, the intervention participants who were abstinent at 6 months had numerically smaller weight gains compared with abstinent participants in the comparison group, but these differences were not statistically significant.
Conclusions:
Providing an intensive weight gain prevention program combined with a smoking cessation program via interactive technology was not associated with greater long-term weight gain prevention.
Background: Varenicline remains the most effective medication for smoking cessation; however, discontinuation as a result of adverse events negatively impacts medication adherence, and the likelihood of a quit attempt being successful. Post-treatment cravings and withdrawal symptoms may also occur, increasing the likelihood of treatment failure, due to lapse and relapse after achieving initial abstinence. This protocol details a trial investigating changes in the effectiveness and tolerability of varenicline, when an extended step-up and step-down regimen are used.
Methods: A phase four, randomised, double-blinded, placebo-controlled single-centre study with a treatment period of 16 weeks, and follow-up period of 12 weeks will be conducted. Up to 201 participants will be enrolled and allocated in a 1:1:1 ratio to a placebo-matching control group, step-up, or step-down intervention group, all receiving behavioural counselling and quitting advice. Participants will be contacted weekly during treatment and fortnightly during follow-up. Eligible participants are smokers over 18 years old, willing to quit smoking, are able to attend clinic visits, and have no uncontrolled or serious medical issues. Primary outcome measures are comparisons of biochemically confirmed continuous abstinence rates, 7-day point prevalence abstinence rates, and the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. Secondary outcome measures are participant adherence to the study medication throughout treatment, and comparisons of changes in smoking satisfaction and reward. Effects of each regimen on smoking cessation will be assessed by logistic regression, with survival analyses used for a more precise estimate of when cessation occurs. Primary endpoints will then be compared using a general linear model. Australian New Zealand Clinical Trials Registry: ACTRN12616000802404p
Introduction:
Smoking cessation-related weight gain can have significant negative health and career consequences for military personnel. Alcohol reduction combined with smoking cessation may decrease weight gain and relapse.
Method:
A randomized clinical trial of military beneficiaries compared a standard smoking cessation (i.e., brief informational) intervention (N=159), with a brief motivational smoking cessation intervention that emphasized reduced drinking to lessen caloric intake and minimize weight gain (N=158).
Results:
Participants who received the motivational intervention were significantly more likely to quit smoking at the 3-month follow-up (p=0.02), but the differences were not maintained at 6 (p=0.18) or 12months (p=0.16). Neither weight change nor alcohol reduction distinguished the 2 groups. Smoking cessation rates at 12months (motivational group=32.91%, informational group=25.79%) were comparable to previous studies, but successful cessation was not mediated by reduced drinking.
Conclusions:
Alcohol reduction combined with smoking cessation did not result in decreased weight gain or improved outcomes.