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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Contacts and 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 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Study ID Numbers: | CN138-089 |
| Study First Received: | April 30, 2004 |
| Last Updated: | July 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00082199 |
| Health Authority: | United States: Food and Drug Administration |
|
Mental Disorders Alcoholism Substance-Related Disorders Disorders of Environmental Origin |
Alcohol-Related Disorders Aripiprazole Ethanol |
|
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |
