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| Sponsor: | Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00580645 |
Purpose
The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking.
Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior and a cue reactivity session assessing their reactivity to alcohol-related cues. Subjects are maintained on study medication for 4 weeks after the laboratory session.
The study is subdivided into three studies based on subject population.
Study 1A enrolls heavy drinking smokers (tested under nicotine deprivation). Study 1B enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Study 1C enrolls smokers (not tested under nicotine deprivation) and nonsmokers who meet criteria for alcohol use disorders.
In Study 1A, volunteers are administered either varenicline (Chantix), bupropion (Zyban), or placebo. In Studies 1B and 1C, volunteers are administered either varenicline (Chantix) or placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Drinking |
Drug: varenicline Drug: bupropion Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment |
| Official Title: | Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking? |
| Estimated Enrollment: | 308 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
varenicline: Experimental
Studies 1A and 1B: varenicline 2mg/day Study 1C: varenicline 1mg/day or 2mg/day |
Drug: varenicline
Studies 1A and 1B: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered twice daily during laboratory session (day 8) and for 4 weeks after laboratory session. Study 1C: 2mg/day (see above) or 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. |
|
Bupropion: Experimental
Study 1A only: Bupropion 300mg/day
|
Drug: bupropion
Study 1A only: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8) and for 4 weeks after laboratory session.
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Placebo: Placebo Comparator
Placebo Controlled
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Drug: placebo
placebo
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Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Erika Balchunas | 203-737-2783 |
| United States, Connecticut | |
| Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Principal Investigator: Sherry A McKee, PhD | |
| Principal Investigator: | Sherry A McKee, PhD | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( Sherry McKee, PhD ) |
| Study ID Numbers: | HIC0702002391, R01AA015596-01 |
| Study First Received: | December 25, 2007 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00580645 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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alcohol smoking cessation varenicline bupropion smoking cessation medications |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Drinking Behavior Psychotropic Drugs Alcohol Drinking Pharmacologic Actions |
Smoking Habits Therapeutic Uses Bupropion Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |