Study of Aripiprazole in Subjects With Alcoholism - Full Text View

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

MedlinePlus related topics:

Alcoholism

Drug Information available for:

Aripiprazole Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

Arms	Assigned Interventions
A1: Active Comparator	Drug: Aripiprazole Tablets, Oral, 2-30mg, Once daily, 12 weeks.
A2: Placebo Comparator	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	Bristol-Myers Squibb

More 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

Publications indexed to this study:

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.

Study ID Numbers:	CN138-089
First Received:	April 30, 2004
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00082199
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mental Disorders

Alcoholism

Substance-Related Disorders

Disorders of Environmental Origin

Alcohol-Related Disorders

Aripiprazole

Ethanol

Additional relevant MeSH terms:

Tranquilizing Agents

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antipsychotic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00082199