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
Aripiprazole
+ Placebo
Alcoholism+2
+ Mental Disorders
+ Substance-Related Disorders
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 21 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Subjects with a diagnosis of alcohol dependence who want to stop using alcohol will be considered for the study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
Local Institution
New Haven, United StatesLocal Institution
Indianapolis, United StatesLocal Institution
Boston, United States