Buprenorphine for Prisoners

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 Overview

• Status: Completed
• Conditions: Heroin Addiction
• Intervention / Treatment: Drug: Buprenorphine +OTP; Drug: Buprenorphine +CHC; Drug: Counseling +OTP; Drug: Counseling +CHC

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 Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Metropolitan Transition Center
    • Jessup, Maryland, United States, 20794
      • Maryland Correctional Institution for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Buprenorphine+OTP; Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.	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; Other Names: Suboxone
EXPERIMENTAL: Buprenorphine+CHC; Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.	Drug: 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.; Other Names: Suboxone
ACTIVE_COMPARATOR: Counseling + OTP; Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)	Drug: 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.; Other Names: Suboxone
ACTIVE_COMPARATOR: Counseling + CHC; Counseling only in prisons and Buprenorphine upon release at a community health center (CHC)	Drug: 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.; Other Names: Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days of Heroin Use	mean days used heroin during the past 30 days	1 year
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: December 12, 2007
• First Submitted That Met QC Criteria: December 12, 2007
• First Posted (ESTIMATE): December 14, 2007

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Heroin Dependence; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Buprenorphine, Naloxone Drug Combination
• Other Study ID Numbers: 1R01DA021579-01A1 (NIH); R01DA021579 (NIH)