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Clinical Trials/NCT00378079
NCT00378079
Completed
Phase 3

Methadone Maintenance for Prisoners

Friends Research Institute, Inc.1 site in 1 country211 target enrollmentSeptember 2003

Overview

Phase
Phase 3
Intervention
Counseling + Methadone
Conditions
Heroin Addiction
Sponsor
Friends Research Institute, Inc.
Enrollment
211
Locations
1
Primary Endpoint
Treatment Retention in the Community
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This five-year study examines the benefits of methadone maintenance treatment initiated in prison and continued in the community to male offenders who were previously, but not currently, heroin-dependent. It is anticipated that such prisoners will have more favorable outcomes in the year following release with regard to drug abuse, crime, and HIV risk behavior than either prisoners who receive counseling only or begin initiation of methadone maintenance in the community

Detailed Description

Most prisoners with histories of pre-incarceration heroin addiction do not receive treatment while incarcerated or upon release. Effective treatment for such prisoners is urgently needed because rapid relapse typically follows release. Relapse is associated with increased risk for HIV, overdose death, criminal activity, and reincarceration. Other than three studies of methadone maintenance with short-term jail inmates, the only study of longer-term inmates who were previously, but not currently, heroin-dependent was the investigator's pilot study with pre-release inmates. Based on that pilot study, which found that initiating maintenance treatment is feasible and facilitates post-release treatment entry, the present study provides a more rigorous examination of this unique treatment approach.

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
January 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Heroin dependence in the year prior to current incarceration
  • 3-6 months left to serve in prison-male pre-release inmate suitability for methadone maintenance as determined by medical evaluation
  • Willingness to enroll in methadone maintenance
  • Having a Baltimore address

Exclusion Criteria

  • Pending parole hearing
  • Pending charges
  • Kidney failure
  • Liver failure

Arms & Interventions

3

Intervention: Counseling + Methadone

1

Intervention: Counseling Only

2

Intervention: Counseling + Transfer

Outcomes

Primary Outcomes

Treatment Retention in the Community

Time Frame: one year post prison release

days in community treatment

Heroin Use

Time Frame: results at one year post prison release

opioid urine test results-percent of participants who were opioid-positive

Criminal Activity

Time Frame: one year post prison release

self reported days of criminal activity

Cocaine Use

Time Frame: one year post prison release

cocaine urine test results-percent of participants testing positive for cocaine

HIV-risk Behaviors

Time Frame: one year

Secondary Outcomes

  • Employment(one year)

Study Sites (1)

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