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Study of Aripiprazole in Subjects With Alcoholism

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00082199
First received: April 30, 2004
Last updated: November 7, 2013
Last verified: July 2008
  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 4

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:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional 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
Study First Received: April 30, 2004
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014