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Study of Aripiprazole in Subjects With Alcoholism

NCT ID: NCT00082199

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

Tablets, Oral, 2-30mg, Once daily, 12 weeks.

A2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, Once daily, 12 weeks.

Interventions

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Aripiprazole

Tablets, Oral, 2-30mg, Once daily, 12 weeks.

Intervention Type DRUG

Placebo

Tablets, Oral, Once daily, 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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Inclusion Criteria

* Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Farmington, Connecticut, United States

Site Status

Local Institution

New Haven, Connecticut, United States

Site Status

Local Institution

Indianapolis, Indiana, United States

Site Status

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Boston, Massachusetts, United States

Site Status

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New York, New York, United States

Site Status

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Rochester, New York, United States

Site Status

Local Institution

Chapel Hill, North Carolina, United States

Site Status

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Philadelphia, Pennsylvania, United States

Site Status

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Providence, Rhode Island, United States

Site Status

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Charleston, South Carolina, United States

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Dallas, Texas, United States

Site Status

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Houston, Texas, United States

Site Status

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Charlottesville, Virginia, United States

Site Status

Local Institution

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Anton RF, Kranzler H, Breder C, Marcus RN, Carson WH, Han J. A randomized, multicenter, double-blind, placebo-controlled study of the efficacy and safety of aripiprazole for the treatment of alcohol dependence. J Clin Psychopharmacol. 2008 Feb;28(1):5-12. doi: 10.1097/jcp.0b013e3181602fd4.

Reference Type DERIVED
PMID: 18204334 (View on PubMed)

Other Identifiers

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CN138-089

Identifier Type: -

Identifier Source: org_study_id