Varenicline Treatment of Alcohol Dependent Smokers

Conditions

Alcohol Abuse | Alcohol Dependence | Smoking

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

The purpose of this study is to determine whether Varenicline is effective in the treatment of alcohol dependence in smokers. Participants will be compensated a total of $525 cash over a 1 year period of time.


Participation Guidelines

Age:
18 Years - 70 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • must be seeking treatment for alcohol drinking
  • met DSM-IV TR Criteria for Alcohol Dependence
  • smoke at least 5 cigarettes a day for the 6 months or more and have a CO of greater than 10ppm.
  • report heavy drinking on at least 2 days on average per week (i.e.: more than 4 drinks on an occasion for women and 5 or more drinks for men) for the past 90 days and no more than 7 consecutive days of abstinence at study intake

Exclusion Criteria:

  • exhibit current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation
  • have a history of cancer (except treated basal cell or squamous cell carcinoma of the skin)
  • have a history of clinically signficant allergic reactions
  • have a Body Mass Index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45 kg
  • are a female of childbearing potential who is pregnant, nursing, or not practicing effective contraception (oral, injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide)
Sponsor:
National Institute on Alcohol Abuse and Alcoholism
Dates:
07/06/2011
Last Updated:
Study HIC#:
1106008598