Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00304707
Recruitment Status : Completed
First Posted : March 20, 2006
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Information provided by (Responsible Party):
David Kalman, National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Alcohol-Related Disorders Drug: Bupropion Drug: placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion Treatment for Smokers in Recovery
Study Start Date : April 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 2
participants in this arm receive bupropion
Drug: Bupropion
300 mg QD

Placebo Comparator: 1
Drug: placebo

Primary Outcome Measures :
  1. Smoking Abstinence [ 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00304707

United States, Massachusetts
ENRM Veterans Hospital
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: David Kalman, PhD Boston University

Responsible Party: David Kalman, Principal Investigatgor, National Institute on Drug Abuse (NIDA) Identifier: NCT00304707     History of Changes
Other Study ID Numbers: R01DA017370 ( U.S. NIH Grant/Contract )
R01DA017370 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2006    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors