Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

This study has been terminated.
(Not enough sugjects enrolled before funding ran out)
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00249379
First received: November 4, 2005
Last updated: April 29, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Alcohol Dependence
Drug: Acamprosate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Drinking and Other Drug Use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants using alcohol and other drugs during 12 weeks

  • Level of Acceptance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants taking study medication during 12 weeks


Secondary Outcome Measures:
  • Retention in Drug Court [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants remaining in drug treatment court program during 12 weeks

  • Recidivism Rates [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants returning to jail during 12 weeks


Enrollment: 26
Study Start Date: June 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249379

Locations
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
Principal Investigator: Michael F. Weaver, MD Virginia Commonwealth University Medical Center
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00249379     History of Changes
Other Study ID Numbers: NIAAAWEA-K23-00222-B  K23AA000222 
Study First Received: November 4, 2005
Results First Received: January 3, 2012
Last Updated: April 29, 2016
Health Authority: United States: Federal Government

Keywords provided by Virginia Commonwealth University:
Alcohol dependence
Acamprosate(drug)
Drug Court
Probation
Parole
Criminal justice

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Acamprosate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Alcohol Deterrents

ClinicalTrials.gov processed this record on August 23, 2016