Effectiveness of Bupropion for Smokers Recovering From Alcohol Dependence
Recruitment status was Recruiting
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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 |
- 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 |
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| 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: Anjali Yakkundi, BA 781-687-2000 ext 5022 anjali.yakkundi@va.gov | |
| 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:
|
Alcoholism Smoking Alcohol-Related Disorders Substance-Related Disorders Mental Disorders 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 May 19, 2013