Clinical Trial: Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Combining Medications Treatment for Alcoholism

Brief Summary: The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

Detailed Summary: This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.
Sponsor: Bankole Johnson

Current Primary Outcome: Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption [ Time Frame: Throughout the study ]

Original Primary Outcome:

Current Secondary Outcome: Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors [ Time Frame: Throughout the study ]

Original Secondary Outcome:

Information By: University of Virginia

Dates:
Date Received: September 11, 2000
Date Started: March 2005
Date Completion: December 2013
Last Updated: March 14, 2013
Last Verified: March 2013