NCT00082199CompletedPhase 4
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
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country400 target enrollmentStarted: April 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Assessment of abstinence from the consumption of alcohol during the study
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.
Exclusion Criteria
- Not provided
Arms & Interventions
A1
Active Comparator
Intervention: Aripiprazole (Drug)
A2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Assessment of abstinence from the consumption of alcohol during the study
Secondary Outcomes
- Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence
Investigators
Study Sites (1)
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