A randomized, controlled trial of bupropion sustained-release for preventing tobacco relapse in recovering alcoholics

Abstract

Introduction: Studies examining the efficacy of tobacco dependence treatment among recovering alcoholic smokers have produced mixed findings. We set out to investigate this issue further by conducting a randomized, double-blind, placebo-controlled trial of bupropion sustained-release (SR) for smoking relapse prevention among abstinent alcoholic smokers.

Methods: Participants (N = 195) met DSM-IV criteria for a history of alcohol abuse or dependence and had at least 1 year of continuous abstinence from alcohol and drugs. Open-label treatment with nicotine patch therapy was provided to all subjects for 8 weeks. The initial nicotine patch dose was determined by the subject's baseline serum cotinine concentration with an aim to achieve 100% cotinine replacement. All subjects who were confirmed abstinent from smoking throughout the final week of nicotine patch therapy (Week 8) were randomly assigned to receive bupropion SR 300 mg/day or placebo through Week 52.

Results: A total of 110 participants were randomized to the double-blind treatment. No significant difference was observed between the bupropion and placebo groups for rates of continuous smoking abstinence, 41.1% (95% CI = 28.1%-55.0%) versus 40.7% (95% CI = 27.6%-55.0%), respectively, p = 1.0, or point prevalence abstinence, 39.3% (95% CI = 26.5%-53.3%) versus 40.7% (95% CI = 27.6%-55.0%), respectively, p = 1.0, at the end of the treatment (Week 52). Relapse to alcohol occurred in 4% of subjects (n = 4) during the study.

Discussion: Treatment with bupropion SR among abstinent alcoholic smokers did not delay relapse or result in improved long-term smoking abstinence.

Figure 1.

Display of the Kaplan–Meier estimates of smoking relapse by treatment group from randomization through Week 76. The dashed line represents the bupropion SR group, the solid line the placebo. p = .965.

Figure 2.

(a) Mean weight change from randomization (Week 8) for all 110 randomized subjects. At Weeks 9, 10, 11, and 12, subjects in the placebo group (solid line) gained significantly more weight than those in the bupropion SR group (dashed line). (b) Mean weight gain for the 42 subjects who were continuously abstinent from smoking through the end of the follow-up phase (Week 76). There were no differences between the bupropion SR (dashed line) and placebo (solid line) groups at any point.