Buprenorphine for Prisoners

Friends Research Institute

Status and phase: Completed; Phase 3

Conditions: Heroin Addiction

Treatments: Drug: Buprenorphine +CHC; Drug: Counseling +OTP; Drug: Buprenorphine +OTP; Drug: Counseling +CHC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00574067

1R01DA021579-01A1 (U.S. NIH Grant/Contract)

R01DA021579 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 213 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 4 patient groups

Buprenorphine+OTP

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine +OTP

Buprenorphine+CHC

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine +CHC

Counseling + OTP

Active Comparator group

Description:

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

Treatment:

Drug: Counseling +OTP

Counseling + CHC

Active Comparator group

Description:

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

Treatment:

Drug: Counseling +CHC