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Study of Aripiprazole in Subjects With Alcoholism

This study has been completed.

Sponsors and Collaborators: Bristol-Myers Squibb
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

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:

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




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