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OpenTrials
Completed

NCT Number: NCT00082199

Study of Aripiprazole 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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution, Farmington, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Aripiprazole

Drug

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

Other names: Abilify

Placebo

Drug

Tablets, Oral, Once daily, 12 weeks.

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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka America Pharmaceutical

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
May 4, 2004
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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