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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00304707 |
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 |
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Smoking Cessation Alcohol-Related Disorders |
Drug: Bupropion Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Bupropion Treatment for Smokers in Recovery |
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 |
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2: Experimental
participants in this arm receive bupropion
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Drug: Bupropion
300 mg QD
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1: Placebo Comparator
placebo
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Drug: placebo
placebo
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Kalman, PhD | 781-687-3019 | david.kalman@va.gov |
United States, Massachusetts | |
ENRM Veterans Hospital | Recruiting |
Bedford, Massachusetts, United States, 01730 | |
Contact: David Kalman, PhD 781-687-3019 david.kalman@va.gov | |
Contact: Margaret Campbell, BA 781-687-2000 ext 5022 Margaret.Campbell2@va.gov |
Principal Investigator: | David Kalman, PhD | Boston University |
Responsible Party: | Boston University ( David Kalman ) |
Study ID Numbers: | R01 DA017370, R01 DA017370 |
Study First Received: | March 17, 2006 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00304707 History of Changes |
Health Authority: | United States: Federal Government |
Dopamine Uptake Inhibitors Neurotransmitter Agents Psychotropic Drugs Disorders of Environmental Origin Smoking Dopamine Mental Disorders Alcoholism |
Bupropion Substance-Related Disorders Alcohol-Related Disorders Dopamine Agents Antidepressive Agents, Second-Generation Antidepressive Agents Ethanol |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Pharmacologic Actions Mental Disorders |
Therapeutic Uses Bupropion Substance-Related Disorders Alcohol-Related Disorders Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |