NCT00574067

Buprenorphine for Prisoners

Completed Phase 3 Results posted Last updated 31 July 2018

What this trial tests

Phase 3 trial testing Buprenorphine +OTP in Heroin Addiction in 213 participants. Completed in 1 November 2013.

Timeline

1 September 2008

Primary endpoint
1 March 2013

1 November 2013

Quick facts

Lead sponsor	Friends Research Institute, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	213
Start date	1 September 2008
Primary completion	1 March 2013
Estimated completion	1 November 2013
Sites	2 locations across United States

Drugs / interventions tested

• Buprenorphine +OTP — full drug profile →
• Buprenorphine +CHC — full drug profile →
• Counseling +OTP — full drug profile →
• Counseling +CHC — full drug profile →

Conditions studied

• Heroin Addiction — all drugs for Heroin Addiction →

Sponsor

Friends Research Institute, Inc.

Who can join

Adults 18 to 60, any sex, with Heroin Addiction. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized controlled trial of prison-initiated buprenorphine: prison outcomes and community treatment entry.
   Gordon MS, Kinlock TW, Schwartz RP, Fitzgerald TT, et al · · 2014 · cited 88× · PMID 24962326 · DOI 10.1016/j.drugalcdep.2014.05.011
2. A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release.
   Gordon MS, Kinlock TW, Schwartz RP, O'Grady KE, et al · · 2017 · cited 48× · PMID 28107680 · DOI 10.1016/j.drugalcdep.2016.11.037
3. Developing and Implementing a New Prison-Based Buprenorphine Treatment Program.
   Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT. · · 2010 · cited 28× · PMID 20473351 · DOI 10.1080/10509670903534951
4. Longitudinal analysis of HIV-risk behaviors of participants in a randomized trial of prison-initiated buprenorphine.
   Blue TR, Gordon MS, Schwartz RP, Couvillion K, et al · · 2019 · cited 5× · PMID 31787108 · DOI 10.1186/s13722-019-0172-2