Do Treatments for Smoking Cessation Affect Alcohol Drinking?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00580645
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

December 25, 2007
December 27, 2007
November 20, 2017
February 7, 2018
February 7, 2018
April 2007
November 2016   (Final data collection date for primary outcome measure)
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
Number of Drinks Consumed [ Time Frame: throughout the laboratory session ]
Complete list of historical versions of study NCT00580645 on Archive Site
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)
tobacco and alcohol craving [ Time Frame: during laboratory session ]
Not Provided
Not Provided
Do Treatments for Smoking Cessation Affect Alcohol Drinking?
Do Treatments for Smoking Cessation Affect Alcohol Drinking?

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Drinking
  • Drug: varenicline
    2mg/day or 1mg/day with 1-week medication lead-in period.
    Other Name: Chantix
  • Drug: placebo
  • Experimental: varenicline
    varenicline 1mg/day or 2mg/day
    Intervention: Drug: varenicline
  • Placebo Comparator: Placebo
    Placebo Controlled
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2016
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01AA015596-01 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Sherry McKee, Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Sherry A McKee, PhD Yale University
Yale University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP