Methadone Maintenance for Prisoners (MMP)

April 1, 2014 updated by: Friends Research Institute, Inc.
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Metropolitan Transition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: Counseling + Transfer
Counseling only in prison, with opportunity to enter methadone maintenance upon release
Experimental: 3
Drug: Counseling + Methadone
Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
Active Comparator: 1
Other: Counseling Only
Counseling only in prison, with passive referral to drug abuse treatment upon release

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Employment
Time Frame: one year
number of days employed, past 30 days-self report, assessed one year post-prison release
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friends Research Institute, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Timothy W Kinlock, Ph.D., Friends Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 15, 2006

First Submitted That Met QC Criteria

September 15, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

April 3, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DA016237-03 (U.S. NIH Grant/Contract)
  • R01DA016237 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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