Buprenorphine for Prisoners

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-11-30

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.

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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.

Conditions

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Heroin Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Buprenorphine+OTP

Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.

Group Type EXPERIMENTAL

Buprenorphine +OTP

Intervention Type DRUG

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

Buprenorphine+CHC

Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.

Group Type EXPERIMENTAL

Buprenorphine +CHC

Intervention Type DRUG

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.

Counseling + OTP

Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)

Group Type ACTIVE_COMPARATOR

Counseling +OTP

Intervention Type DRUG

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.

Counseling + CHC

Counseling only in prisons and Buprenorphine upon release at a community health center (CHC)

Group Type ACTIVE_COMPARATOR

Counseling +CHC

Intervention Type DRUG

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.

Interventions

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Buprenorphine +OTP

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

Intervention Type DRUG

Buprenorphine +CHC

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.

Intervention Type DRUG

Counseling +OTP

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.

Intervention Type DRUG

Counseling +CHC

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.

Intervention Type DRUG

Other Intervention Names

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Suboxone Suboxone Suboxone Suboxone

Eligibility Criteria

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Inclusion Criteria

1. pre-release prison inmate with 3-6 months remaining until planned release
2. 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
3. suitability for buprenorphine treatment as determined by medical evaluation
4. willingness to participate in the study
5. having a Baltimore address and planning to live in Baltimore after release from prison -

Exclusion Criteria

1. evidence of kidney failure
2. evidence of liver failure
3. history of psychosis
4. having a pending parole hearing
5. unadjudicated charges that could result in additional prison time or transfer to another facility -

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes