NCT00249379

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

May 11, 2016

Completed
Last Updated

May 11, 2016

Status Verified

April 1, 2016

Enrollment Period

3.2 years

First QC Date

November 4, 2005

Results QC Date

January 3, 2012

Last Update Submit

April 29, 2016

Conditions

Alcohol Dependence

Keywords

Alcohol dependenceAcamprosate(drug)Drug CourtProbationParoleCriminal justice

Outcome Measures

Primary Outcomes (2)

  • Drinking and Other Drug Use

    Number of participants using alcohol and other drugs during 12 weeks

    12 weeks

  • Level of Acceptance

    Number of participants taking study medication during 12 weeks

    12 weeks

Secondary Outcomes (2)

  • Retention in Drug Court

    12 weeks

  • Recidivism Rates

    12 weeks

Study Arms (2)

Acamprosate

EXPERIMENTAL

Subjects randomized to receive acamprosate

Drug: Acamprosate

No medication

NO INTERVENTION

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

Interventions

AcamprosateDRUG

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

Also known as: Campral
Acamprosate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Limitations and Caveats

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

Results Point of Contact

Title
Michael Weaver, MD
Organization
Virginia Commonwealth University
mweaver@mcvh-vcu.edu
804-828-1283

Study Officials

  • Michael F. Weaver, MD

    Virginia Commonwealth University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 7, 2005

Study Start

June 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 11, 2016

Results First Posted

May 11, 2016

Record last verified: 2016-04

Locations

US(1)