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Completed

NCT Number: NCT00378079

Methadone Maintenance for Prisoners

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

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Key information

Conditions

Heroin Addiction Chemically-Induced Disorders Heroin Dependence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Metropolitan Transition Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling Only

Other

Counseling only in prison, with passive referral to drug abuse treatment upon release

Counseling + Transfer

Drug

Counseling only in prison, with opportunity to enter methadone maintenance upon release

Counseling + Methadone

Drug

Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release

Primary outcomes

  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 outcomes

  1. Employment

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: MMP

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2006
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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