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Randomized Controlled Trial
. 2009 Sep;104(9):1588-96.
doi: 10.1111/j.1360-0443.2009.02624.x. Epub 2009 Jun 22.

Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum

Ned L Cooney  1 , Judith L Cooney, Bridget L Perry, Michael Carbone, Emily H Cohen, Howard R Steinberg, David T Pilkey, Kevin Sevarino, Cheryl A Oncken, Mark D Litt
Affiliations
Randomized Controlled Trial

Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum

Ned L Cooney et al. Addiction. 2009 Sep.

Abstract

Aims: The primary aim was to compare the efficacy of smoking cessation treatment using a combination of active nicotine patch plus active nicotine gum versus therapy consisting of active nicotine patch plus placebo gum in a sample of alcohol-dependent tobacco smokers in an early phase of out-patient alcohol treatment. A secondary aim was to determine whether or not there were any carry-over effects of combination nicotine replacement on drinking outcomes.

Design: Small-scale randomized double-blind placebo-controlled clinical trial with 1-year smoking and drinking outcome assessment.

Setting: Two out-patient substance abuse clinics provided a treatment platform of behavioral alcohol and smoking treatment delivered in 3 months of weekly sessions followed by three monthly booster sessions.

Participants: Participants were 96 men and women with a diagnosis of alcohol abuse or dependence and smoking 15 or more cigarettes per day.

Intervention: All participants received open-label transdermal nicotine patches and were randomized to receive either 2 mg nicotine gum or placebo gum under double-blind conditions.

Findings: Analysis of 1-year follow-up data revealed that patients receiving nicotine patch plus active gum had better smoking outcomes than those receiving patch plus placebo gum on measures of time to smoking relapse and prolonged abstinence at 12 months. Alcohol outcomes were not significantly different across medication conditions.

Conclusions: Results of this study were consistent with results of larger trials of smokers without alcohol problems, showing that combination therapy (nicotine patch plus gum) is more effective than monotherapy (nicotine patch) for smoking cessation.

Trial registration: ClinicalTrials.gov NCT00064844.

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Conflict of interest statement

Conflict of interest statement: Judith Cooney and Kevin Sevarino have worked as promotional speakers for Pfizer, Inc.

Figures

Figure 1
Figure 1
Study profile.
Figure 2
Figure 2
Percent prolonged CO-verified smoking abstinence by gum condition across follow-ups.
Figure 3
Figure 3
Estimated survival functions for time to smoking relapse by gum condition.
See this image and copyright information in PMC

References

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