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Study of Aripiprazole in Subjects With Alcoholism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00082199
Recruitment Status : Completed
First Posted : May 4, 2004
Last Update Posted : November 11, 2013
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Aripiprazole Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2004
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Assessment of abstinence from the consumption of alcohol during the study

Secondary Outcome Measures :
  1. Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00082199     History of Changes
Other Study ID Numbers: CN138-089
First Posted: May 4, 2004    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: July 2008

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs