Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence - Tabular View

Tracking Information

First Received Date ^ICMJE

March 17, 2006

Last Updated Date

September 4, 2009

Start Date ^ICMJE

April 2005

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Smoking abstinence (measured at Week 7) [ Time Frame: week 10, week 15 and week 27 after scheduled quit day ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Smoking abstinence (measured at Week 7)

Change History

Complete list of historical versions of study NCT00304707 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

Official Title ^ICMJE

Bupropion Treatment for Smokers in Recovery

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Smoking Cessation
Alcohol-Related Disorders

Intervention ^ICMJE

Drug: Bupropion
Drug: placebo

Study Arms / Comparison Groups

Experimental: participants in this arm receive bupropion
Placebo Comparator: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

236

Estimated Completion Date

February 2010

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: David Kalman, PhD

781-687-3019

david.kalman@va.gov

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00304707

Responsible Party

David Kalman, Boston University

Study ID Numbers ^ICMJE

R01 DA017370, R01 DA017370, DPMCDA

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David Kalman, PhD

Boston University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP