Clinical trial NCT00574067: Buprenorphine for Prisoners
Official title: Buprenorphine for Prisoners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heroin Addiction
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-12-14
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Number of Days of Heroin Use
timeFrame: 1 year
measure: Drug Abuse Treatment Entry and Retention in the Community
timeFrame: 1 year
Secondary outcomes:
measure: Number of Days of Cocaine Use
timeFrame: 1 year
measure: Criminal Activity
timeFrame: 1 year
measure: Employment Status
timeFrame: 1 year
measure: HIV Risk Behavior Needle Sharing
timeFrame: 1 year
measure: HIV Risk Behavior
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Metropolitan Transition Center
state: Maryland
city: Jessup
country: United States
facility: Maryland Correctional Institution for Women
state: Maryland
Study officials:
References:
citation: Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT. Developing and Implementing a New Prison-Based Buprenorphine Treatment Program. J Offender Rehabil. 2010 Feb;49(2):91-109. doi: 10.1080/10509670903534951.
citation: Gordon MS, Kinlock TW, Schwartz RP, Couvillion KA, O'Grady KE. The Severity, Frequency, and Variety of Crime in Heroin-Dependent Prisoners Enrolled in a Buprenorphine Clinical Trial. Prison J. 2013 Dec 1;93(4):390-410. doi: 10.1177/0032885513500753.
citation: Blue TR, Gordon MS, Schwartz RP, Couvillion K, Vocci FJ, Fitzgerald TT, O'Grady KE. Longitudinal analysis of HIV-risk behaviors of participants in a randomized trial of prison-initiated buprenorphine. Addict Sci Clin Pract. 2019 Dec 2;14(1):45. doi: 10.1186/s13722-019-0172-2.