Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

April 29, 2016 updated by: Virginia Commonwealth University

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acamprosate
Subjects randomized to receive acamprosate
Drug: Acamprosate
Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence
Other Names:
  • Campral
No Intervention: No medication
No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinking and Other Drug Use
Time Frame: 12 weeks
Number of participants using alcohol and other drugs during 12 weeks
12 weeks
Level of Acceptance
Time Frame: 12 weeks
Number of participants taking study medication during 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in Drug Court
Time Frame: 12 weeks
Number of participants remaining in drug treatment court program during 12 weeks
12 weeks
Recidivism Rates
Time Frame: 12 weeks
Number of participants returning to jail during 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Michael F. Weaver, MD, Virginia Commonwealth University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAWEA-K23-00222-B
  • K23AA000222 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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