search
Back to results

Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

Primary Purpose

Smoking Cessation, Alcohol-Related Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bupropion
placebo
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ENRM Veterans Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2

1

Arm Description

participants in this arm receive bupropion

placebo

Outcomes

Primary Outcome Measures

Smoking Abstinence
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.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2006
Last Updated
May 4, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00304707
Brief Title
Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence
Official Title
Bupropion Treatment for Smokers in Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Alcohol-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
participants in this arm receive bupropion
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Description
300 mg QD
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Smoking Abstinence
Description
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.
Time Frame
week 7, week 11 and week 24 after scheduled quit day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kalman, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ENRM Veterans Hospital
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

We'll reach out to this number within 24 hrs