Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

Smoking Cessation Clinical Trial

Official title:

Bupropion Treatment for Smokers in Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00304707
• Other study ID #: R01DA017370
• Secondary ID: R01DA017370DPMCD
• Status: Recruiting
• Phase: Phase 3
• First received: March 17, 2006
• Last updated: September 4, 2009
• Start date: April 2005
• Est. completion date: February 2010

Study information

• Verified date: September 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: David Kalman, PhD
• Phone: 781-687-3019
• Email: david.kalman[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Smoking Cessation

Intervention

Drug:
• Bupropion
300 mg QD
• placebo
placebo

Locations

Country	Name	City	State
United States	ENRM Veterans Hospital	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence (measured at Week 7)		week 10, week 15 and week 27 after scheduled quit day	No