Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Phase 4

Terminated

• Conditions: Alcohol Dependence
• Interventions: Drug: Acamprosate

• Registration Number: NCT00249379
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).

Detailed Description

Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole.

Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-11-04
• Study First Submitted QC: 2005-11-04
• Study First Posted: 2005-11-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2012-01-03
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-29
• Last Update Submitted: 2016-04-29
• Results First Posted: 2016-05-11
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• History of alcohol dependence in the year before entering criminal justice supervision
• Currently under criminal justice supervision (drug court, probation, or parole) in central Virginia

Exclusion Criteria

• Pregnant or nursing a baby
• Known sensitivity to acamprosate
• Elevated serum creatinine level or other evidence of kidney problems
• Symptoms of severe depression or suicidal ideation
• Non-English speaking such that they cannot provide informed consent
• Cognitive impairment such that they cannot provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acamprosate	Acamprosate	Subjects randomized to receive acamprosate

Primary Outcome Measures

Name	Time	Method
Drinking and Other Drug Use	12 weeks	Number of participants using alcohol and other drugs during 12 weeks
Level of Acceptance	12 weeks	Number of participants taking study medication during 12 weeks

Secondary Outcome Measures

Name	Time	Method
Retention in Drug Court	12 weeks	Number of participants remaining in drug treatment court program during 12 weeks
Recidivism Rates	12 weeks	Number of participants returning to jail during 12 weeks

Trial Locations

Locations (1)

Virginia Commonwealth University Medical Center; 🇺🇸 Richmond, Virginia, United States