Study of Aripiprazole in Subjects With Alcoholism

This study has been completed.

First Received on April 30, 2004. Last Updated on April 7, 2011 History of Changes

Sponsor:	Bristol-Myers Squibb
Collaborator:	Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00082199

Purpose

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.

Condition	Intervention	Phase
Alcoholism	Drug: Aripiprazole Drug: Placebo	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Assessment of abstinence from the consumption of alcohol during the study

Secondary Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	April 2004
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A1	Drug: Aripiprazole Tablets, Oral, 2-30mg, Once daily, 12 weeks. Other Name: Abilify
Placebo Comparator: A2	Drug: Placebo Tablets, Oral, Once daily, 12 weeks.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082199

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Anton RF, Kranzler H, Breder C, Marcus RN, Carson WH, Han J. A randomized, multicenter, double-blind, placebo-controlled study of the efficacy and safety of aripiprazole for the treatment of alcohol dependence. J Clin Psychopharmacol. 2008 Feb;28(1):5-12.

ClinicalTrials.gov Identifier:	NCT00082199 History of Changes
Other Study ID Numbers:	CN138-089
Study First Received:	April 30, 2004
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012