Do Treatments for Smoking Cessation Affect Alcohol Drinking?
Completed · Phase 2 · Has a placebo group
Conditions studied: Alcohol Drinking
In brief
The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated. Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior. Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.
Key facts
- Study ID
- NCT00580645
- Run by
- Yale University
- People needed
- 60
- Starts
- 2007-04-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2018-02-07
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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