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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?

Brief Summary:

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.


Detailed Summary:
Sponsor: Yale University

Current Primary Outcome: number of drinks consumed [ Time Frame: throughout the laboratory session ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • tobacco and alcohol craving [ Time Frame: during laboratory session ]
  • tobacco and alcohol craving [ Time Frame: during the cue reactivity session ]


Original Secondary Outcome: tobacco and alcohol craving [ Time Frame: during laboratory session ]

Information By: Yale University

Dates:
Date Received: December 25, 2007
Date Started: April 2007
Date Completion: December 2017
Last Updated: November 22, 2016
Last Verified: November 2016