Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-08-31

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).

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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.

Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acamprosate

Subjects randomized to receive acamprosate

Group Type EXPERIMENTAL

Acamprosate

Intervention Type DRUG

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

No medication

No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acamprosate

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

Intervention Type DRUG

Other Intervention Names

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Campral

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No