Clinical trial NCT00304707: Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence
Official title: Bupropion Treatment for Smokers in Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Alcohol-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2006-03-20
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry
* Abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry
* Meets criteria for alcohol dependence or abuse in the 12 months prior to study entry

Exclusion Criteria:

* History of seizures, head trauma and/or severe hepatic cirrhosis
* Current use of medications known to affect smoking behavior and/or cessation
* Use of tricyclic antidepressant medication and monoamine oxidase inhibitors
* Major depressive disorder within the month prior to study entry
* Eating disorder within the year prior to study entry
* History of bipolar or psychotic disorder
* Pregnant or breastfeeding
* Unstable serious medical disorder
* History of migraines
* Currently using smokeless tobacco, pipes, or cigars

Primary outcomes:
measure: Smoking Abstinence
timeFrame: week 7, week 11 and week 24 after scheduled quit day
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: ENRM Veterans Hospital
state: Massachusetts
Study officials:
affiliation: Boston University
name: David Kalman, PhD
role: PRINCIPAL_INVESTIGATOR
References: