Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Alcohol Dependence Clinical Trial

Official title:

The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249379
• Other study ID #: NIAAAWEA-K23-00222-B
• Secondary ID: K23AA000222NIH G
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2005
• Last updated: October 10, 2011
• Start date: June 2005
• Est. completion date: August 2008

Study information

• Verified date: October 2011
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Acamprosate
Alcohol-dependent criminal justice supervisees will receive acamprosate

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of drinking and other drug use		Study period	No
Primary	Level of acceptance		Study period	No
Secondary	Retention in drug court		Study period	No
Secondary	Days of employment		Study period	No
Secondary	Stable housing		Study period	No
Secondary	Recidivism rates		Study period	No