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: 4.28). 03/2009; 36(2):96-104.e1. DOI: 10.1016/j.amepre.2008.09.039
Source: PubMed

ABSTRACT 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: 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).
    01/2015; 2:196-201. DOI:10.1016/j.pmedr.2015.02.014
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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.
    Nicotine & Tobacco Research 06/2014; 16(7). DOI:10.1093/ntr/ntu087 · 2.81 Impact Factor
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    • "***p<0.001 this particular analysis; the OR observed for the prediction of abstinence was comparable to earlier reduction studies (Shiffman et al. 2009); however, the wide confidence interval indicates a large variance in the current sample. "
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    ABSTRACT: Patches are traditionally started on the day a quit attempt begins. Recently, a number of studies have established that the patch's effectiveness is improved by starting the treatment before quitting [pre-quit patch (PQP) use]. In an exploratory study, we investigate a proposed mechanism through which PQP use might promote abstinence: that PQP reduces satisfaction with smoking (either directly or via craving), which in turn leads to reduction and that smoking reduction promotes abstinence. Fifty-seven interested quitters used handheld computers to monitor their smoking satisfaction, withdrawal and smoking in real time for 17 days, leading up to a quit attempt. All participants received 21 mg/24 h patches for 2 weeks before and for up to 10 weeks after quitting. Carbon dioxide (CO)-verified 28-day abstinence was assessed. During PQP treatment, participants reported significant reductions in both the satisfaction gained from smoking (p < 0.001) and their daily cigarette consumption (p < 0.001). Craving did not decrease; however, there was an interaction between time and nicotine dependence; craving decreased only among low dependent participants. Multilevel structural equation modelling revealed a direct effect of satisfaction on smoking rate. Craving did not mediate this relationship. Smoking reduction during the PQP treatment phase was not significantly associated with abstinence. The real-time data collection protocol utilised allowed for a fine-grained examination of smoking during PQP treatment. The results suggest that the reduction in daily cigarette smoking typically observed during PQP treatment is due to reductions in satisfaction with smoking. Unlike previous studies, however, smoking reduction was not significantly related to later abstinence, even though the odds ratio was comparably. Potential clinical implications of these findings are discussed.
    Psychopharmacology 01/2014; 231(13). DOI:10.1007/s00213-013-3430-0 · 3.99 Impact Factor
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