Clinical Trial: Combined Pharmacotherapies for Alcoholism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Combined Pharmacotherapies for Alcoholism

Brief Summary: This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.

Detailed Summary: We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.
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 ]

Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT


Original Primary Outcome: EOA, compared with LOA, will be more responsive to treatment with either ondansetron or naltrexone alone. The combination of ondansetron and naltrexone will be superior to either medication alone in the treatment of EOA. [ Time Frame: Throughout the study ]

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 ]

Pill Count, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM


Original Secondary Outcome: The combination of ondansetron and naltrexone will be better tolerated than naltrexone alone. [ Time Frame: Throughout the study ]

Information By: University of Virginia

Dates:
Date Received: October 6, 2008
Date Started: September 2008
Date Completion:
Last Updated: March 14, 2013
Last Verified: March 2013