Back to resultsStudy of Aripiprazole in Subjects With Alcoholism
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism
Eligibility Criteria
Inclusion Criteria: Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A1
A2
Arm Description
Outcomes
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
Full Information
NCT ID
NCT00082199
First Posted
April 30, 2004
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00082199
Brief Title
Study of Aripiprazole in Subjects With Alcoholism
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, Oral, 2-30mg, Once daily, 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, Once daily, 12 weeks.
Primary Outcome Measure Information:
Title
Assessment of abstinence from the consumption of alcohol during the study
Secondary Outcome Measure Information:
Title
Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Rochester
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18204334
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Aripiprazole in Subjects With Alcoholism
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