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Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status and phase

Terminated
Phase 4

Conditions

Alcohol Dependence

Treatments

Drug: Acamprosate

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00249379
K23AA000222 (U.S. NIH Grant/Contract)
NIAAAWEA-K23-00222-B

Details and patient eligibility

About

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 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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