Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Overview

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).

Full Title of Study: “The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

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.

Interventions

  • Drug: Acamprosate
    • Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence

Arms, Groups and Cohorts

  • Experimental: Acamprosate
    • Subjects randomized to receive acamprosate
  • No Intervention: No medication
    • No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Collaborator
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael F. Weaver, MD, Principal Investigator, Virginia Commonwealth University Medical Center

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