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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00082199

Enrollment

400

Registered

2004-05-04

Start date

2004-04-30

Completion date

2005-08-31

Last updated

2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

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.

Interventions

DRUGAripiprazole

Tablets, Oral, 2-30mg, Once daily, 12 weeks.

DRUGPlacebo

Tablets, Oral, Once daily, 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Assessment of abstinence from the consumption of alcohol during the study	—

Secondary

Measure	Time frame
Assessment of alcohol use during the study and behavioral measures of substance abuse an dependence	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026