Study of Aripiprazole in Subjects With Alcoholism

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States
        • Local Institution
      • New Haven, Connecticut, United States
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
      • Rochester, New York, United States
        • Local Institution
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • Rhode Island
      • Providence, Rhode Island, United States
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
    • Virginia
      • Charlottesville, Virginia, United States
        • Local Institution
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A1
Drug: Aripiprazole
Tablets, Oral, 2-30mg, Once daily, 12 weeks.
Other Names:
  • Abilify
Placebo Comparator: A2
Drug: Placebo
Tablets, Oral, Once daily, 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of abstinence from the consumption of alcohol during the study

Secondary Outcome Measures

Outcome Measure
Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

April 30, 2004

First Submitted That Met QC Criteria

May 3, 2004

First Posted (Estimate)

May 4, 2004

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

July 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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