Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00249379
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 26
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 0.7

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence	Drug: Acamprosate	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of Acamprosate for Preventing Alcohol Relapse Among Alcohol Dependent Drug Treatment Court Participants
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Drinking and Other Drug Use [12 weeks]

   Number of participants using alcohol and other drugs during 12 weeks

2. Level of Acceptance [12 weeks]

   Number of participants taking study medication during 12 weeks

Secondary Outcome Measures

1. Retention in Drug Court [12 weeks]

   Number of participants remaining in drug treatment court program during 12 weeks

2. Recidivism Rates [12 weeks]

   Number of participants returning to jail during 12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University Medical Center	Richmond	Virginia	United States	23219

Sponsors and Collaborators

• Virginia Commonwealth University
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Michael F. Weaver, MD, Virginia Commonwealth University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT00249379
• Other Study ID Numbers: NIAAAWEA-K23-00222-B; K23AA000222
• First Posted: Nov 7, 2005
• Last Update Posted: May 11, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Virginia Commonwealth University: Alcohol dependence; Acamprosate(drug); Drug Court; Probation; Parole; Criminal justice
• Additional relevant MeSH terms: Alcoholism; Acamprosate

Study Results

Participant Flow

Arm/Group Title	Acamprosate	Control
Arm/Group Description	Criminal justice supervisees given acamprosate 333 mg, 2 tablets orally 3 times daily for alcohol dependence for a 12-week period	No specific intervention, received standard Drug Court counseling, monitored for outcomes
Period Title: Overall Study
STARTED	14	12
COMPLETED	6	4
NOT COMPLETED	8	8

Baseline Characteristics

Arm/Group Title	Acamprosate	Control	Total
Arm/Group Description	Criminal justice supervisees given acamprosate for alcohol dependence	No specific intervention, monitored for outcomes	Total of all reporting groups
Overall Participants	14	12	26
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	12 100%	26 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.9 (3)	37.9 (3)	37.9 (3)
Sex: Female, Male (Count of Participants)
Female	4 28.6%	3 25%	7 26.9%
Male	10 71.4%	9 75%	19 73.1%
Region of Enrollment (participants) [Number]
United States	14 100%	12 100%	26 100%

Outcome Measures

1. Primary Outcome

Title	Drinking and Other Drug Use
Description	Number of participants using alcohol and other drugs during 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study.

Arm/Group Title	Acamprosate	Control
Arm/Group Description	participants taking study medication
Measure Participants	13	0
Number [participants]	6 42.9%

2. Primary Outcome

Title	Level of Acceptance
Description	Number of participants taking study medication during 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study.

Arm/Group Title	Acamprosate	Control
Arm/Group Description	participants taking study medication
Measure Participants	13	0
Number [participants]	13 92.9%

3. Secondary Outcome

Title	Retention in Drug Court
Description	Number of participants remaining in drug treatment court program during 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study.

Arm/Group Title	Acamprosate	Control
Arm/Group Description	participants taking study medication
Measure Participants	13	0
Number [participants]	13 92.9%

4. Secondary Outcome

Title	Recidivism Rates
Description	Number of participants returning to jail during 12 weeks
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study.

Arm/Group Title	Acamprosate	Control
Arm/Group Description	participants taking study medication
Measure Participants	13	0
Number [participants]	5 35.7%

Adverse Events

Arm/Group Title	Acamprosate		Control
Arm/Group Description	Criminal justice supervisees given acamprosate for alcohol dependence		No specific intervention, monitored for outcomes
All Cause Mortality
	Acamprosate		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Acamprosate		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Acamprosate		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/12 (0%)

Limitations/Caveats

Small numbers of subjects, significant number withdrew or were lost to follow-up

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.