Quitting by Gradual Smoking Reduction Using Nicotine Gum A Randomized Controlled Trial

Pinney Associates, Inc., and the University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
American journal of preventive medicine (Impact Factor: 4.53). 03/2009; 36(2):96-104.e1. DOI: 10.1016/j.amepre.2008.09.039
Source: PubMed


Many smokers express a desire to quit smoking by gradually reducing the number of cigarettes they smoke until they stop completely. This study tested the efficacy of nicotine gum in facilitating cessation through gradual reduction.
This was a multi-center, placebo-controlled, double-blind RCT of 2- and 4-mg nicotine gum versus placebo.
3297 smokers who were interested in quitting gradually.
Subjects were instructed to gradually reduce their smoking while increasing their gum use over the course of up to 8 weeks. Once they had achieved initial abstinence (no smoking for 24 hours), gum was to be used in accordance with the current FDA-approved directions for cessation. The study was conducted under over-the-counter conditions, with no counseling provided. Continuous abstinence was assessed after 28 days and 6 months. Secondary measures of smoking reduction were also assessed. Analyses were conducted in 1999-2000 and 2007-2008.
Smokers on active gum were significantly more likely to achieve initial cessation (2 mg: OR=1.42; 4 mg: OR=1.90); 28-day continuous abstinence (2 mg: OR=2.01; 4 mg: OR=4.66); and continuous abstinence at 6 months (2 mg: OR=1.80; 4 mg: OR=5.96). During the reduction phase, active gum aided smoking reduction, and participants who reduced their smoking were more likely to achieve abstinence.
These findings demonstrate that smokers who wish to quit smoking by gradual reduction can increase their success by using nicotine gum to facilitate reduction and cessation.

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    • "While traditional cessation strategies (e.g., motivational interviewing, stage-matched intervention) might not help some smokers to achieve cessation, reduction is appealing because making progression towards the goal of complete cessation reflects visible behavioral change (Carpenter et al., 2004). Experimental studies have found that smoking reduction intervention combining medication and counseling is effective for smokers without intention to quit (Asfar et al., 2011; Batra et al., 2005; Bolliger et al., 2000; Carpenter et al., 2004; Chan et al., 2011; Rennard et al., 2006; Shiffman et al., 2009; Wennike et al., 2003), but it is not clear whether the increase in quitting is due to NRT availability, reduction itself , or both (Asfar et al., 2011). Although a few studies have found the dose–response effect between reduction quantity and later abstinence (Broms et al., 2008; Falba et al., 2004; Farkas, 1999; Hughes et al., 2004), these studies arbitrarily categorized reduction quantity and assumed a few thresholds of reduction for cessation. "
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    ABSTRACT: Objective: We examined how quantity and trajectory of smoking reduction influence later abstinence in smokers without intention to quit and being prescribed free nicotine replacement therapy (NRT). Method: We conducted an a posteriori analysis from a data archive of adult smokers in a randomized controlled trial of smoking reduction using counseling and free NRT (n= 928). Reduction was analyzed as the absolute and percentage decrease in self-reported daily cigarette consumption at three follow-ups (1. week, 1 and 3. months) compared with the baseline. Logistic regression model and multiple imputation were used to examine the association between early reduction and abstinence at 6. months. Results: Reducing 10% of cigarette consumption at the three follow-ups was associated with 16% (95% CI 5-28%), 23% (95%CI 11-36%) and 27% (95% CI 13-42%) increase in abstinence, respectively. Greater reduction predicted abstinence when the percentage reduction was more than one-third (above 31.4%). Progressive increase in the percentage reduction predicted more abstinence (OR = 1.90, 95%CI 1.01-3.58). Conclusions: Greater percentage reduction by at least one-third and progressive reduction predicted abstinence in those who reduced smoking. Such new evidence can guide the improvement of clinical service for tobacco dependency treatment and support further studies on smoking reduction and cessation.
    Full-text · Article · Dec 2015
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    • "A recent secondary analysis of the large scale RCT of 5 smoking cessation pharmacotherapies (Piper et al., 2009), demonstrated that greater suppression of smoking craving was the mechanism by which combination therapy resulted in significantly higher quit rates than monotherapy (Bolt, Piper, Theobald, & Baker, 2012). It has also been suggested, though not proven, that the addition of acute NRT to nicotine patch treatment may afford smokers a tool for reacting to acute episodes of craving that may arise even on patch treatment, and which are associated with smoking lapses (Ferguson & Shiffman, 2009). Further, the benefits of combination NRT are unlikely to simply reflect a higher nicotine dose, since high-dose patches have modest incremental efficacy (Stead et al., 2012), while adding acute NRT medicines to patch results in significant gains in efficacy with only modest increases in nicotine dose. "
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    ABSTRACT: Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions, optimizing existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe, and as effective as starting NRT on quit date, and specifically prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for: combined use of faster-acting NRT medications with nicotine patch; nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt; and prolonged NRT for up to 6 months without healthcare provider consultation.
    Full-text · Article · Jun 2014 · Nicotine & Tobacco Research
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    • "Smokers with insomnia may benefit from flexible quit dates and more intensive smoking pharmacotherapy treatment . Clinical trials of NRT and varenicline show that gradual smoking cessation while on medication (i.e., allowing for smoking reduction and flexibility to delay quitting until later in treatment) is just as effective as abrupt cessation through a scheduled quit date (Hughes, Solomon, Livingston, Callas, & Peters, 2010; Rennard et al., 2012; Shiffman, Ferguson, & Strahs, 2009). Many smokers, particularly those who smoke heavily, also prefer flexible reduction to abrupt cessation (Hughes, Callas, & Peters, 2007; Shiffman et al., 2007). "
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    ABSTRACT: Introduction: Sleep disturbance is common among cigarette smokers and predicts smoking cessation failure. Aims: The purpose of this study was to conduct a pilot test of whether provision of a sleep intervention might bolster smoking cessation outcomes among this vulnerable group. Methods: Smokers with insomnia (N = 19) seeking smoking cessation treatment were randomly assigned to receive 8 sessions over 10 weeks of either: (1) cognitive-behavioural therapy for insomnia + smoking cessation counselling (CBT-I+SC; n = 9) or (2) smoking cessation counselling alone (SC; n = 10). Counselling commenced 4 weeks prior to a scheduled quit date, and nicotine patch therapy was also provided for 6 weeks starting on the quit date. Results: There was no significant effect of counselling condition on smoking cessation outcomes. Most participants had difficulty initiating and maintaining smoking abstinence in that 7-day point prevalence abstinence rates at end of treatment (CBT-I+SC: 1/7, 14%; SC: 2/10, 20%) and follow-up (CBT-I+SC: 1/7, 14%; SC: 0/10, 0%) were low for both conditions. CBT-I+SC participants reported improvements in sleep efficiency, quality, duration and insomnia symptoms. Sleep changes were not associated with the likelihood of achieving smoking abstinence. Conclusions: This randomised pilot study suggests that behavioural interventions may improve sleep among smokers with insomnia, but a larger sample is needed to replicate this finding and evaluate whether these changes facilitate smoking cessation.
    Full-text · Article · Jun 2014 · The Journal of Smoking Cessation
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