Clinical trials have shown transdermal nicotine therapy to be an effective adjunct in helping non-alcoholic smokers to stop smoking. Limited information suggests that recovering alcoholic smokers are more nicotine dependent than their nonalcoholic counterparts. However, post-hoc analyses of nicotine patch studies show that recovering alcoholics can achieve initial abstinence from smoking but have a high relapse rate to smoking. Bupropion appears to be an effective adjunct for smoking cessation and this medication lends itself to long-term use as a pharmacologic agent for relapse prevention. The overall goal of this work is to ultimately reduce mortality from tobacco-related diseases in recovering alcoholics. The theoretical framework on which this proposal is based is that achieving initial abstinence from and preventing relapse to smoking using pharmacologic adjuncts will improve the long-term abstinence rates, thus reducing the risk of tobacco related mortality. We chose to focus this proposal on pharmacologic relapse prevention using bupropion since this is the least understood and studied area. The hypothesis to be tested is that following initial smoking cessation with nicotine patch therapy relapse to smoking can be reduced using bupropion as a pharmacologic agent. Our specific aims are: 1) Determine if long-term use of bupropion will reduce the rate of relapse to smoking compared to placebo in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. 2) Determine the week 8 smoking cessation rate in recovering alcoholics provided a nicotine patch dose projected to achieve 100% replacement. We propose to test this hypothesis and accomplish these aims by providing 292 recovering alcoholic smokers with a nicotine patch dose expected to achieve 100% replacement. Those abstinent from smoking during the entire 8th week of nicotine patch therapy will enter a 44 week randomized, double-blind, placebo controlled trial of bupropion for pharmacologic relapse prevention with long-term follow-up to 76 weeks.
|Effective start/end date||8/1/97 → 7/31/02|
- National Institutes of Health: $291,619.00
- National Institutes of Health: $248,976.00
- National Institutes of Health: $263,850.00
- National Institutes of Health
Tobacco Use Cessation Products