Buprenorphine for Prisoners

Phase 3

Completed

• Conditions: Heroin Addiction
• Interventions: Drug: Buprenorphine +OTP; Drug: Counseling +CHC; Drug: Buprenorphine +CHC; Drug: Counseling +OTP

• Registration Number: NCT00574067
• Lead Sponsor: Friends Research Institute, Inc.

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.

Study Timeline

• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-14
• Study Start: 2008-09
• Primary Completion: 2013-03
• Study Completion: 2013-11
• Results First Submitted: 2015-08-11
• Results First Submitted QC: 2016-03-11
• Results First Posted: 2016-04-11
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine+OTP	Buprenorphine +OTP	Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.
Counseling + CHC	Counseling +CHC	Counseling only in prisons and Buprenorphine upon release at a community health center (CHC)
Buprenorphine+CHC	Buprenorphine +CHC	Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.
Counseling + OTP	Counseling +OTP	Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Criminal Activity	1 year	Days of crime during the past 30 days
Employment Status	1 year	Number of days employed during the past year
HIV Risk Behavior Needle Sharing	1 year	Number of times shared a needle during the past year
Number of Days of Cocaine Use	1 year	Number of days used cocaine during the past 30 days.
HIV Risk Behavior	1 year	Number of times had sex without using a condom during the past year

Trial Locations

Locations (2)

Maryland Correctional Institution for Women; 🇺🇸 Jessup, Maryland, United States

Metropolitan Transition Center; 🇺🇸 Baltimore, Maryland, United States