Methadone Maintenance for Prisoners

Study Overview
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Brief Summary
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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
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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.

Official Title
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Methadone Maintenance for Prisoners

Conditions
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Heroin Addiction

Intervention / Treatment
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* Other: Counseling Only
* Drug: Counseling + Transfer
* Drug: Counseling + Methadone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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