Do Treatments for Smoking Cessation Affect Alcohol Drinking?
NCT ID: NCT00580645
Last Updated: 2018-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2007-04-30
2016-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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varenicline
varenicline 1mg/day or 2mg/day
varenicline
2mg/day or 1mg/day with 1-week medication lead-in period.
Placebo
Placebo Controlled
placebo
placebo
Interventions
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varenicline
2mg/day or 1mg/day with 1-week medication lead-in period.
placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Yale University
OTHER
Responsible Party
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Sherry McKee
Associate Professor of Psychiatry
Principal Investigators
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Sherry A McKee, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory
New Haven, Connecticut, United States
Countries
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References
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Roberts W, McKee SA. Effects of varenicline on cognitive performance in heavy drinkers: Dose-response effects and associations with drinking outcomes. Exp Clin Psychopharmacol. 2018 Feb;26(1):49-57. doi: 10.1037/pha0000161.
Other Identifiers
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HIC0702002391
Identifier Type: -
Identifier Source: org_study_id
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