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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

March 17, 2006
September 4, 2009
April 2005
July 2009   (final data collection date for primary outcome measure)
Smoking abstinence (measured at Week 7) [ Time Frame: week 10, week 15 and week 27 after scheduled quit day ] [ Designated as safety issue: No ]
Smoking abstinence (measured at Week 7)
Complete list of historical versions of study NCT00304707 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence
Bupropion Treatment for Smokers in Recovery

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Smoking Cessation
  • Alcohol-Related Disorders
  • Drug: Bupropion
    300 mg QD
  • Drug: placebo
    placebo
  • Experimental: 2
    participants in this arm receive bupropion
    Intervention: Drug: Bupropion
  • Placebo Comparator: 1
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
236
February 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: David Kalman, PhD 781-687-3019 david.kalman@va.gov
United States
 
NCT00304707
R01 DA017370, R01 DA017370, DPMCDA
Not Provided
David Kalman, Boston University
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: David Kalman, PhD Boston University
National Institute on Drug Abuse (NIDA)
September 2009

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