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Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking? - NCT00580645-06519(Clinical Trial 196850)



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City:  New Haven
State:  
CT
Zip Code: 06519
Conditions: Alcohol Drinking
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.
Study summary:
Criteria: Inclusion Criteria: - 21 years old or older - Able to read and write in English - Smokers, non-daily smokers, and non-smokers - Heavy Drinkers and/or meet criteria for alcohol use disorders Exclusion Criteria: - Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol - Significant hepatocellular injury - Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines - Women who are pregnant or nursing - Suicidal, homicidal, or evidence of severe mental illness - Prescription of any psychotropic drug in the 30 days prior to study enrollment - Blood donation within the past 8 weeks - Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months - Specific exclusions for administration of bupropion not specified above including: having taken monoamine inhibitors in the past six weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology - Known allergy to varenicline or taking H2blockers - Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study - Subjects likely to exhibit clinically significant alcohol withdrawal during the study
Study is available at: Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory
New Haven, CT 06519
United States

Primary Contact:
Sabrina Coppola
Phone: 203-737-2783
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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