Buprenorphine for Prisoners

• ClinicalTrials.gov Identifier: NCT00574067
• Recruitment Status: Completed
• First Posted: December 14, 2007
• Results First Posted: April 11, 2016
• Last Update Posted: August 29, 2018
• Sponsor: Friends Research Institute, Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Friends Research Institute, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heroin Addiction	Drug: Buprenorphine +OTP; Drug: Buprenorphine +CHC; Drug: Counseling +OTP; Drug: Counseling +CHC	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 213 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Buprenorphine for Prisoners
• Study Start Date: September 2008
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: November 2013

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: Suboxone

Outcome Measures

Primary Outcome Measures :

1. Number of Days of Heroin Use [ Time Frame: 1 year ]
   mean days used heroin during the past 30 days
2. 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)

Secondary Outcome Measures :

1. Number of Days of Cocaine Use [ Time Frame: 1 year ]
   Number of days used cocaine during the past 30 days.
2. Criminal Activity [ Time Frame: 1 year ]
   Days of crime during the past 30 days
3. Employment Status [ Time Frame: 1 year ]
   Number of days employed during the past year
4. HIV Risk Behavior Needle Sharing [ Time Frame: 1 year ]
   Number of times shared a needle during the past year
5. HIV Risk Behavior [ Time Frame: 1 year ]
   Number of times had sex without using a condom during the past year

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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 -

Contacts and Locations

Locations

United States, Maryland

Metropolitan Transition Center

Baltimore, Maryland, United States, 21201

Maryland Correctional Institution for Women

Jessup, Maryland, United States, 20794

Sponsors and Collaborators

Friends Research Institute, Inc.

National Institute on Drug Abuse (NIDA)

More Information

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT00574067
• Other Study ID Numbers: 1R01DA021579-01A1 ( U.S. NIH Grant/Contract ); R01DA021579 ( U.S. NIH Grant/Contract ); 1R01DA021579-01A1 ( U.S. NIH Grant/Contract )
• First Posted: December 14, 2007
• Results First Posted: April 11, 2016
• Last Update Posted: August 29, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

Heroin Dependence; Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists