Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00304707
First received: March 17, 2006
Last updated: September 4, 2009
Last verified: September 2009
  Purpose

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 Intervention Phase
Smoking Cessation
Alcohol-Related Disorders
Drug: Bupropion
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion Treatment for Smokers in Recovery

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

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

Estimated Enrollment: 236
Study Start Date: April 2005
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
participants in this arm receive bupropion
Drug: Bupropion
300 mg QD
Placebo Comparator: 1
placebo
Drug: placebo
placebo

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304707

Contacts
Contact: David Kalman, PhD 781-687-3019 david.kalman@va.gov

Locations
United States, Massachusetts
ENRM Veterans Hospital Recruiting
Bedford, Massachusetts, United States, 01730
Contact: David Kalman, PhD    781-687-3019    david.kalman@va.gov   
Contact: Anjali Yakkundi, BA    781-687-2000 ext 5022    anjali.yakkundi@va.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: David Kalman, PhD Boston University
  More Information

No publications provided

Responsible Party: David Kalman, Boston University
ClinicalTrials.gov Identifier: NCT00304707     History of Changes
Other Study ID Numbers: R01 DA017370, R01 DA017370, DPMCDA
Study First Received: March 17, 2006
Last Updated: September 4, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Smoking
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Alcoholism
Habits
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014