Do Treatments for Smoking Cessation Affect Alcohol Drinking?
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|ClinicalTrials.gov Identifier: NCT00580645|
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking||Drug: varenicline Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Do Treatments for Smoking Cessation Affect Alcohol Drinking?|
|Actual Study Start Date :||April 2007|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
varenicline 1mg/day or 2mg/day
2mg/day or 1mg/day with 1-week medication lead-in period.
Other Name: Chantix
Placebo Comparator: Placebo
- Number of Drinks Consumed [ Time Frame: 2 hour ad-lib drinking period, during the laboratory session (Day 8) ]number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session
- Alcohol Craving [ Time Frame: during laboratory session (Day 8) at baseline ]alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580645
|United States, Connecticut|
|Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Sherry A McKee, PhD||Yale University|