ENRM Veterans Hospital
Bedford, Massachusetts, 01730, United States
NCT Number: NCT00304707
Smoking is often a problem for alcohol dependent individuals. Many people who seek treatment for alcohol dependence are unable to quit smoking. The purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Bedford, Massachusetts, 01730, United States
Past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. Many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate that these smokers find it very difficult to quit smoking. More effective treatment methods are needed for smokers in early alcohol recovery. Bupropion is a dopaminergic antidepressant that may be effective in treating nicotine dependent individuals. The purpose of this study is to evaluate the effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol dependence. In addition, this study will investigate the psychological mechanisms that may mediate the efficacy of bupropion in smoking cessation. We will also collect DNA from subjects in order to explore whether response to bupropion is mediated by particular genetic variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers.
Participants will be randomly assigned to receive either 300 mg of bupropion or placebo, daily for 8 weeks. In addition, all participants will receive a nicotine patch for 7 weeks. This will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks, and a 7-mg nicotine patch for 1 week. All participants will undergo seven counseling sessions. Follow-up visits will occur at Weeks 7, 12, and 24. Pre-quit variables (e.g., smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and negative effects) will be evaluated at all study visits.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
300 mg QD
placebo
Time frame: week 7, week 11 and week 24 after scheduled quit day
The number of subjects in each treatment group who were smoking abstinent (7-day point prevalence) at week 7 (end of treatment), week 11 and week 24.
National Institute on Drug Abuse (NIDA)
Nih
Bupropion Treatment for Smokers in Recovery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06663020
Behavior, Bronchial Neoplasms
Samsun, Turkey (Türkiye)
View Trial DetailsNCT04881630
Behavior, Health Behavior
Oklahoma City, Oklahoma, United States
View Trial DetailsNCT04620915
Behavior, Cancer
Eugene, Oregon, United States
View Trial DetailsNCT03950427
Behavior, Chemically-Induced Disorders
San Francisco, California, United States
View Trial Details