CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 213 enrolled
Drug / intervention
Buprenorphine +OTP +3 moredrug
Likely dose
Buprenorphine +OTP 32 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00574067
NCT00574067Phase 3Completed

Buprenorphine for Prisoners

Friends Research Institute, Inc.·interventional·Posted Dec 14, 2007·Updated Aug 29, 2018

In Brief

A Phase 3 clinical trial evaluating Buprenorphine +OTP, Buprenorphine +CHC, and 2 other interventions for Heroin Addiction. Completed, enrolled 213 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2007
Enrollment StartSep 1, 2008
Primary CompletionMar 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.6 years ago

Interventions

Buprenorphine +OTPdrug

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 +CHCdrug

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 +OTPdrug

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 +CHCdrug

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.