Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Phase 2

• Conditions: Alcoholism
• Interventions: Drug: ondansetron + cognitive behavioral therapy; Drug: Placebo + cognitive behavioral therapy; Drug: topiramate + cognitive behavioral therapy; Drug: ondansetron + topiramate + cognitive behavioral therapy

• Registration Number: NCT00006205
• Lead Sponsor: Bankole Johnson

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 Description

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.

Study Timeline

• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2000-09-11
• Study First Posted: 2000-09-12
• Study Start: 2005-03
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-15
• Primary Completion: 2013-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.
• Provide a written, informed consent.
• Good physical health and must weigh within at least 40 kg and no more than 140 kg.
• Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.
• Willingness to participate in behavioral treatments for alcoholism.
• Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months.

Exclusion Criteria

Please contact site for additional information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ondansetron	ondansetron + cognitive behavioral therapy	Ondansetron + cognitive behavioral therapy
Placebo	Placebo + cognitive behavioral therapy	Placebo + cognitive behavioral therapy
Topiramate	topiramate + cognitive behavioral therapy	Topiramate + cognitive behavioral therapy
Ondansetron + Topiramate	ondansetron + topiramate + cognitive behavioral therapy	Ondansetron + Topiramate + cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption	Throughout the study	Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT

Secondary Outcome Measures

Name	Time	Method
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors	Throughout the study	Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM

Trial Locations

Locations (1)

University of Virginia Center for Addiction Research and Education; 🇺🇸 Richmond, Virginia, United States