Study of Aripiprazole in Subjects With Alcoholism

Phase 4

Completed

• Conditions: Alcoholism
• Interventions: Drug: Placebo; Drug: Aripiprazole

• Registration Number: NCT00082199
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

The purpose of this clinical research study is to learn whether subjects treated with aripiprazole are able to abstain from alcohol use for a greater number of days than subjects treated with placebo. The safety of using aripiprazole will also be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-04-30
• Study First Submitted QC: 2004-05-03
• Study First Posted: 2004-05-04
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2008-07
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Placebo	-
A1	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Assessment of abstinence from the consumption of alcohol during the study

Secondary Outcome Measures

Name	Time	Method
Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Milwaukee, Wisconsin, United States