Methadone Maintenance for Prisoners

Phase 3

Completed

• Conditions: Heroin Addiction
• Interventions: Drug: Counseling + Methadone; Other: Counseling Only; Drug: Counseling + Transfer

• Registration Number: NCT00378079
• Lead Sponsor: Friends Research Institute, Inc.

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2006-09-15
• Study First Submitted QC: 2006-09-15
• Study First Posted: 2006-09-19
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2013-08-14
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-01
• Last Update Submitted: 2014-04-01
• Results First Posted: 2014-04-03
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Counseling + Methadone	-
1	Counseling Only	-
2	Counseling + Transfer	-

Primary Outcome Measures

Name	Time	Method
Treatment Retention in the Community	one year post prison release	days in community treatment
Heroin Use	results at one year post prison release	opioid urine test results-percent of participants who were opioid-positive
Criminal Activity	one year post prison release	self reported days of criminal activity
HIV-risk Behaviors	one year
Cocaine Use	one year post prison release	cocaine urine test results-percent of participants testing positive for cocaine

Secondary Outcome Measures

Name	Time	Method
Employment	one year	number of days employed, past 30 days-self report, assessed one year post-prison release

Trial Locations

Locations (1)

Metropolitan Transition Center; 🇺🇸 Baltimore, Maryland, United States