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Nicotine & Tobacco Research Advance Access published online on May 29, 2009
Nicotine & Tobacco Research, doi:10.1093/ntr/ntp077
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© The Author 2009. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org

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

J. Taylor Hays, Richard D. Hurt, Paul A. Decker, Ivana T. Croghan, Kenneth P. Offord and Christi A. Patten

J. Taylor Hays, M.D., Department of Internal Medicine, Mayo Clinic College of Medicine, Mayo Clinic Nicotine Dependence Center, Rochester, MN
Richard D. Hurt, M.D., Department of Internal Medicine, Mayo Clinic College of Medicine, Mayo Clinic Nicotine Dependence Center, Rochester, MN
Paul A. Decker, M.S., Department of Health Sciences Research, Division of Biostatistics, Mayo Clinic College of Medicine, Rochester, MN
Ivana T. Croghan, Ph.D., Department of Internal Medicine, Mayo Clinic College of Medicine, Mayo Clinic Nicotine Dependence Center, Rochester, MN
Kenneth P. Offord, M.S., Department of Health Sciences Research, Division of Biostatistics, Mayo Clinic College of Medicine, Rochester, MN
Christi A. Patten, Ph.D., Department of Psychiatry and Psychology, Mayo Clinic College of Medicine, Rochester, MN

Corresponding Author: J. Taylor Hays, M.D., Mayo Clinic Nicotine Dependence Center, 200 1st Street Southwest, Rochester, MN 55905, USA. Telephone: 507-538-6341; Fax: 507-284-4959; E-mail: hays.taylor{at}mayo.edu


  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.

Received: July 28, 2008; Accepted: February 17, 2009
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