Methadone Maintenance for Prisoners (MMP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00378079
First received: September 15, 2006
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Heroin Addiction
Other: Counseling Only
Drug: Counseling + Transfer
Drug: Counseling + Methadone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Methadone Maintenance for Prisoners

Resource links provided by NLM:


Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Treatment Retention in the Community [ Time Frame: one year post prison release ] [ Designated as safety issue: No ]
    days in community treatment

  • Heroin Use [ Time Frame: results at one year post prison release ] [ Designated as safety issue: No ]
    opioid urine test results-percent of participants who were opioid-positive

  • Cocaine Use [ Time Frame: one year post prison release ] [ Designated as safety issue: No ]
    cocaine urine test results-percent of participants testing positive for cocaine

  • HIV-risk Behaviors [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Criminal Activity [ Time Frame: one year post prison release ] [ Designated as safety issue: No ]
    self reported days of criminal activity


Secondary Outcome Measures:
  • Employment [ Time Frame: one year ] [ Designated as safety issue: No ]
    number of days employed, past 30 days-self report, assessed one year post-prison release


Enrollment: 211
Study Start Date: September 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 2 Drug: Counseling + Transfer
Counseling only in prison, with opportunity to enter methadone maintenance upon release

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378079

Locations
United States, Maryland
Metropolitan Transition Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Friends Research Institute, Inc.
Investigators
Principal Investigator: Timothy W Kinlock, Ph.D. Friends Research Institute, Inc.
  More Information

Publications:
Gordon MS, Kinlock TW, Schwartz RP, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-reelase. Addiction 103:1333-1342,2008
Wilson, M.E., Kinlock, T.W., Gordon, M.S., O'Grady, K.E., & Schwartz, R.P. (2012). HIV-risk behaviors among male prisoners participating in a randomized clinical trial of methadone maintenance treatment. American Journal on Addictions, 21,476-487.
Kinlock TW, Schwartz RP, Gordon MS. The significance of interagency collaboration in developing opioid agonist programs for inmates. Corrections Compendium 30(3)6-9,28-30,2005.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00378079     History of Changes
Other Study ID Numbers: 1 RO1 DA 16237-03, R01DA016237
Study First Received: September 15, 2006
Results First Received: August 14, 2013
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heroin Dependence
Behavior, Addictive
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014