Study of Aripiprazole in Subjects With Alcoholism

Alcoholism Clinical Trial

Official title:

A Randomized, Multicenter, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Aripiprazole in the Maintenance of Abstinence From Alcohol in Subjects With Alcoholism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082199
• Other study ID #: CN138-089
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2004
• Last updated: November 7, 2013
• Start date: April 2004
• Est. completion date: August 2005

Study information

• Verified date: July 2008
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Aripiprazole
Tablets, Oral, 2-30mg, Once daily, 12 weeks.
• Placebo
Tablets, Oral, Once daily, 12 weeks.

Locations

Country	Name	City	State
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Chapel Hill	North Carolina
United States	Local Institution	Charleston	South Carolina
United States	Local Institution	Charlottesville	Virginia
United States	Local Institution	Dallas	Texas
United States	Local Institution	Farmington	Connecticut
United States	Local Institution	Houston	Texas
United States	Local Institution	Indianapolis	Indiana
United States	Local Institution	Milwaukee	Wisconsin
United States	Local Institution	New Haven	Connecticut
United States	Local Institution	New York	New York
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Providence	Rhode Island
United States	Local Institution	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of abstinence from the consumption of alcohol during the study
Secondary	Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm