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Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Primary Purpose

Alcohol Dependence

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acamprosate
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol dependence, Acamprosate(drug), Drug Court, Probation, Parole, Criminal justice

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Virginia Commonwealth University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acamprosate

No medication

Arm Description

Subjects randomized to receive acamprosate

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

Outcomes

Primary Outcome Measures

Drinking and Other Drug Use
Number of participants using alcohol and other drugs during 12 weeks
Level of Acceptance
Number of participants taking study medication during 12 weeks

Secondary Outcome Measures

Retention in Drug Court
Number of participants remaining in drug treatment court program during 12 weeks
Recidivism Rates
Number of participants returning to jail during 12 weeks

Full Information

First Posted
November 4, 2005
Last Updated
April 29, 2016
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00249379
Brief Title
Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees
Official Title
The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Not enough sugjects enrolled before funding ran out
Study Start Date
June 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol dependence, Acamprosate(drug), Drug Court, Probation, Parole, Criminal justice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acamprosate
Arm Type
Experimental
Arm Description
Subjects randomized to receive acamprosate
Arm Title
No medication
Arm Type
No Intervention
Arm Description
No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling
Intervention Type
Drug
Intervention Name(s)
Acamprosate
Other Intervention Name(s)
Campral
Intervention Description
Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence
Primary Outcome Measure Information:
Title
Drinking and Other Drug Use
Description
Number of participants using alcohol and other drugs during 12 weeks
Time Frame
12 weeks
Title
Level of Acceptance
Description
Number of participants taking study medication during 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Retention in Drug Court
Description
Number of participants remaining in drug treatment court program during 12 weeks
Time Frame
12 weeks
Title
Recidivism Rates
Description
Number of participants returning to jail during 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F. Weaver, MD
Organizational Affiliation
Virginia Commonwealth University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

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