Study of Aripiprazole in Subjects With Alcoholism

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00082199
First received: April 30, 2004
Last updated: November 7, 2013
Last verified: July 2008

April 30, 2004
November 7, 2013
April 2004
August 2005   (final data collection date for primary outcome measure)
Assessment of abstinence from the consumption of alcohol during the study
Not Provided
Complete list of historical versions of study NCT00082199 on ClinicalTrials.gov Archive Site
Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alcoholism
  • Drug: Aripiprazole
    Tablets, Oral, 2-30mg, Once daily, 12 weeks.
    Other Name: Abilify
  • Drug: Placebo
    Tablets, Oral, Once daily, 12 weeks.
  • Active Comparator: A1
    Intervention: Drug: Aripiprazole
  • Placebo Comparator: A2
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
August 2005
August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00082199
CN138-089
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP