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Buprenorphine for Prisoners

Primary Purpose

Heroin Addiction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine +OTP
Buprenorphine +CHC
Counseling +OTP
Counseling +CHC
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heroin Addiction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • Metropolitan Transition Center
  • Maryland Correctional Institution for Women

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Buprenorphine+OTP

Buprenorphine+CHC

Counseling + OTP

Counseling + CHC

Arm Description

Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.

Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.

Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)

Counseling only in prisons and Buprenorphine upon release at a community health center (CHC)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2007
Last Updated
July 31, 2018
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00574067
Brief Title
Buprenorphine for Prisoners
Official Title
Buprenorphine for Prisoners
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Addiction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine+OTP
Arm Type
Experimental
Arm Description
Buprenorphine and counseling in prison and continued at opioid treatment program (OTP) upon release.
Arm Title
Buprenorphine+CHC
Arm Type
Experimental
Arm Description
Buprenorphine and counseling in prison and continued at a community health center (CHC) upon release.
Arm Title
Counseling + OTP
Arm Type
Active Comparator
Arm Description
Counseling only in prison and Buprenorphine upon release at a opioid treatment program (OTP)
Arm Title
Counseling + CHC
Arm Type
Active Comparator
Arm Description
Counseling only in prisons and Buprenorphine upon release at a community health center (CHC)
Intervention Type
Drug
Intervention Name(s)
Buprenorphine +OTP
Other Intervention Name(s)
Suboxone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Buprenorphine +CHC
Other Intervention Name(s)
Suboxone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Counseling +OTP
Other Intervention Name(s)
Suboxone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Counseling +CHC
Other Intervention Name(s)
Suboxone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Days of Heroin Use
Description
mean days used heroin during the past 30 days
Time Frame
1 year
Title
Drug Abuse Treatment Entry and Retention in the Community
Description
entered community treatment within 10 days of release from prison (yes vs. no)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Days of Cocaine Use
Description
Number of days used cocaine during the past 30 days.
Time Frame
1 year
Title
Criminal Activity
Description
Days of crime during the past 30 days
Time Frame
1 year
Title
Employment Status
Description
Number of days employed during the past year
Time Frame
1 year
Title
HIV Risk Behavior Needle Sharing
Description
Number of times shared a needle during the past year
Time Frame
1 year
Title
HIV Risk Behavior
Description
Number of times had sex without using a condom during the past year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pre-release prison inmate with 3-6 months remaining until planned release 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 suitability for buprenorphine treatment as determined by medical evaluation willingness to participate in the study having a Baltimore address and planning to live in Baltimore after release from prison - Exclusion Criteria: evidence of kidney failure evidence of liver failure history of psychosis having a pending parole hearing unadjudicated charges that could result in additional prison time or transfer to another facility -
Facility Information:
Facility Name
Metropolitan Transition Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Maryland Correctional Institution for Women
City
Jessup
State/Province
Maryland
ZIP/Postal Code
20794
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20473351
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. doi: 10.1080/10509670903534951.
Results Reference
background
PubMed Identifier
25392564
Citation
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.
Results Reference
background
PubMed Identifier
31787108
Citation
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.
Results Reference
derived

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Buprenorphine for Prisoners

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