Skip to main content
OpenTrials
Completed

NCT Number: NCT00580645

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Health Behavior Smoking Cessation

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

2mg/day or 1mg/day with 1-week medication lead-in period.

Other names: Chantix

Placebo

Drug

placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Dec 27, 2007
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.