Buprenorphine for Prisoners

Heroin Addiction Clinical Trial

Official title:

Buprenorphine for Prisoners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574067
• Other study ID #: 1R01DA021579-01A1
• Secondary ID: R01DA0215791R01D
• Status: Completed
• Phase: Phase 3
• Start date: September 2008
• Est. completion date: November 2013

Study information

• Verified date: July 2018
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: November 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Heroin Addiction
• Heroin Dependence

Intervention

Drug:
• Buprenorphine +OTP
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 +CHC
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 +OTP
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 +CHC
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.

Locations

Country	Name	City	State
United States	Metropolitan Transition Center	Baltimore	Maryland
United States	Maryland Correctional Institution for Women	Jessup	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days of Heroin Use	mean days used heroin during the past 30 days	1 year
Primary	Drug Abuse Treatment Entry and Retention in the Community	entered community treatment within 10 days of release from prison (yes vs. no)	1 year
Secondary	Number of Days of Cocaine Use	Number of days used cocaine during the past 30 days.	1 year
Secondary	Criminal Activity	Days of crime during the past 30 days	1 year
Secondary	Employment Status	Number of days employed during the past year	1 year
Secondary	HIV Risk Behavior Needle Sharing	Number of times shared a needle during the past year	1 year
Secondary	HIV Risk Behavior	Number of times had sex without using a condom during the past year	1 year