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Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00249379
Recruitment Status : Terminated (Not enough sugjects enrolled before funding ran out)
First Posted : November 7, 2005
Results First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Acamprosate Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants
Study Start Date : June 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Campral
No Intervention: No medication
No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling


Outcome Measures
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Primary Outcome Measures :
  1. Drinking and Other Drug Use [ Time Frame: 12 weeks ]
    Number of participants using alcohol and other drugs during 12 weeks

  2. Level of Acceptance [ Time Frame: 12 weeks ]
    Number of participants taking study medication during 12 weeks


Secondary Outcome Measures :
  1. Retention in Drug Court [ Time Frame: 12 weeks ]
    Number of participants remaining in drug treatment court program during 12 weeks

  2. Recidivism Rates [ Time Frame: 12 weeks ]
    Number of participants returning to jail during 12 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249379


Locations
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United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Michael F. Weaver, MD Virginia Commonwealth University Medical Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00249379    
Other Study ID Numbers: NIAAAWEA-K23-00222-B
K23AA000222 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2005    Key Record Dates
Results First Posted: May 11, 2016
Last Update Posted: May 11, 2016
Last Verified: April 2016
Keywords provided by Virginia Commonwealth University:
Alcohol dependence
Acamprosate(drug)
Drug Court
 Probation
Parole
Criminal justice
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Acamprosate
Alcohol Deterrents