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Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Kalman, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00304707
First received: March 17, 2006
Last updated: May 4, 2017
Last verified: May 2017
  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
Intervention Model: Factorial Assignment
Masking: Participant, Care Provider, 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 David Kalman, National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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.


Enrollment: 143
Study Start Date: April 2005
Study Completion Date: February 2011
Primary Completion Date: February 2010 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304707

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

Responsible Party: David Kalman, Principal Investigatgor, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00304707     History of Changes
Other Study ID Numbers: R01DA017370 ( US NIH Grant/Contract Award Number )
Study First Received: March 17, 2006
Results First Received: April 5, 2017
Last Updated: May 4, 2017

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
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

ClinicalTrials.gov processed this record on May 25, 2017