Study of Aripiprazole in Subjects With Alcoholism
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00082199
First received: April 30, 2004
Last updated: April 7, 2011
Last verified: July 2008
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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:
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 | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
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: | 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 May 16, 2013