Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00249379

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 IV

MedlinePlus related topics: Alcoholism

Drug Information available for: Acamprosate Acamprosate calcium Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Days of drinking and other drug use [ Time Frame: Study period ] [ Designated as safety issue: No ]
Level of acceptance [ Time Frame: Study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Retention in drug court [ Time Frame: Study period ] [ Designated as safety issue: No ]
Days of employment [ Time Frame: Study period ] [ Designated as safety issue: No ]
Stable housing [ Time Frame: Study period ] [ Designated as safety issue: No ]
Recidivism rates [ Time Frame: Study period ] [ Designated as safety issue: No ]

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
1: Experimental acamprosate	Drug: Acamprosate Alcohol-dependent criminal justice supervisees will receive acamprosate
2: No Intervention no intervention

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
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

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

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 ( Michael F. Weaver, MD, Study Principal Investigator )
Study ID Numbers:	NIAAAWEA-K23-00222-B, NIH Grant K23 AA00222
Study First Received:	November 4, 2005
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00249379
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Alcohol dependence
Acamprosate(drug)
Drug Court

Probation
Parole
Criminal justice

Study placed in the following topic categories:

Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin

Alcohol-Related Disorders
Acamprosate
Ethanol

Additional relevant MeSH terms:

Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents

ClinicalTrials.gov processed this record on January 14, 2009