Study of Aripiprazole in Subjects With Alcoholism
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
1 other identifier
interventional
400
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2004
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 30, 2004
CompletedFirst Posted
Study publicly available on registry
May 4, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedNovember 11, 2013
July 1, 2008
1.3 years
April 30, 2004
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of abstinence from the consumption of alcohol during the study
Secondary Outcomes (1)
Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence
Study Arms (2)
A1
ACTIVE COMPARATORA2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Local Institution
Farmington, Connecticut, United States
Local Institution
New Haven, Connecticut, United States
Local Institution
Indianapolis, Indiana, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
New York, New York, United States
Local Institution
Rochester, New York, United States
Local Institution
Chapel Hill, North Carolina, United States
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Providence, Rhode Island, United States
Local Institution
Charleston, South Carolina, United States
Local Institution
Dallas, Texas, United States
Local Institution
Houston, Texas, United States
Local Institution
Charlottesville, Virginia, United States
Local Institution
Milwaukee, Wisconsin, United States
Related Publications (1)
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.
PMID: 18204334DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 30, 2004
First Posted
May 4, 2004
Study Start
April 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
November 11, 2013
Record last verified: 2008-07