Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Acamprosate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol dependence, Acamprosate(drug), Drug Court, Probation, Parole, Criminal justice