Buprenorphine for Prisoners

Study Overview
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Brief Summary
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This five-year study examines the effectiveness of buprenorphine treatment provided to previously-addicted inmates(N=320; 160 males, 160 females) initiated in prison and continued in the community. The study also examines the extent to which the setting of post-release buprenorphine is provided.It is expected that participants receiving in-prison buprenorphine will have superior outcomes compared to participants who did not receive in-prison buprenorphine.

Detailed Description
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Participants will be randomly assigned, within gender, to one of four treatment conditions: 1) buprenorphine and counseling in prison, with referral for continued treatment at an OTP upon release; 2) buprenorphine and counseling in prison, with referral for continued treatment at a CHC upon release; 3) counseling only in prison, with referral for buprenorphine and counseling at a OTP upon release; and 4) counseling only in prison, with referral for buprenorphine and counseling at a CHC upon release. Participants will be assessed at study entry and at 1, 3, 6, and 12 months following their release from prison. Outcome measures include: treatment entry and retention in the community, heroin use, cocaine use, HIV infection, HIV-risk behaviors, criminal activity, and employment.

Official Title
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Buprenorphine for Prisoners

Conditions
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Heroin Addiction

Intervention / Treatment
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* Drug: Buprenorphine +OTP
* Drug: Buprenorphine +CHC
* Drug: Counseling +OTP
* Drug: Counseling +CHC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pre-release prison inmate with 3-6 months remaining until planned release history of heroin dependence(meeting DSM-IV criteria of heroin dependence at the time of incarceration and manifesting physical dependence during the year preceding incarceration suitability for buprenorphine treatment as determined by medical evaluation willingness to participate in the study having a Baltimore address and planning to live in Baltimore after release from prison - Exclusion Criteria: evidence of kidney failure evidence of liver failure history of psychosis having a pending parole hearing unadjudicated charges that could result in additional prison time or transfer to another facility -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine+OTP<br>Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release. | Drug: Buprenorphine +OTP<br>* Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment (OTP) program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays<br>* Other names: Suboxone;|
| Experimental: Buprenorphine+CHC<br>Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release. | Drug: Buprenorphine +CHC<br>* Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center (CHC). Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.<br>* Other names: Suboxone;|
| Active Comparator: Counseling + OTP<br>Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP) | Drug: Counseling +OTP<br>* Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.<br>* Other names: Suboxone;|
| Active Comparator: Counseling + CHC<br>Counseling only in prisons and Buprenorphine upon release at a community health center (CHC) | Drug: Counseling +CHC<br>* Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.<br>* Other names: Suboxone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days of Heroin Use | mean days used heroin during the past 30 days | 1 year | 
| Drug Abuse Treatment Entry and Retention in the Community | entered community treatment within 10 days of release from prison (yes vs. no) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days of Cocaine Use | Number of days used cocaine during the past 30 days. | 1 year | 
| Criminal Activity | Days of crime during the past 30 days | 1 year | 
| Employment Status | Number of days employed during the past year | 1 year | 
| HIV Risk Behavior Needle Sharing | Number of times shared a needle during the past year | 1 year | 
| HIV Risk Behavior | Number of times had sex without using a condom during the past year | 1 year |