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Methadone Maintenance for Prisoners (MMP)

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ClinicalTrials.gov Identifier: NCT00378079
Recruitment Status : Completed
First Posted : September 19, 2006
Results First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Heroin Addiction Other: Counseling Only Drug: Counseling + Transfer Drug: Counseling + Methadone Phase 3

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  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methadone Maintenance for Prisoners
Study Start Date : September 2003
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Treatment Retention in the Community [ Time Frame: one year post prison release ]
    days in community treatment

  2. Heroin Use [ Time Frame: results at one year post prison release ]
    opioid urine test results-percent of participants who were opioid-positive

  3. Cocaine Use [ Time Frame: one year post prison release ]
    cocaine urine test results-percent of participants testing positive for cocaine

  4. HIV-risk Behaviors [ Time Frame: one year ]
  5. Criminal Activity [ Time Frame: one year post prison release ]
    self reported days of criminal activity


Secondary Outcome Measures :
  1. Employment [ Time Frame: one year ]
    number of days employed, past 30 days-self report, assessed one year post-prison release



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378079


Locations
United States, Maryland
Metropolitan Transition Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Timothy W Kinlock, Ph.D. Friends Research Institute, Inc.

Publications of Results:
Other Publications:
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.

Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00378079     History of Changes
Other Study ID Numbers: 1R01DA016237-03 ( U.S. NIH Grant/Contract )
R01DA016237 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2006    Key Record Dates
Results First Posted: April 3, 2014
Last Update Posted: April 3, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents