NCT00574067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 11, 2016

Completed
Last Updated

August 29, 2018

Status Verified

July 1, 2018

Enrollment Period

4.5 years

First QC Date

December 12, 2007

Results QC Date

August 11, 2015

Last Update Submit

July 31, 2018

Conditions

Heroin Addiction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Number of Days of Cocaine Use

    1 year

  • Criminal Activity

    1 year

  • Employment Status

    1 year

  • HIV Risk Behavior Needle Sharing

    1 year

  • HIV Risk Behavior

    1 year

Study Arms (4)

Buprenorphine+OTP

EXPERIMENTAL

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

Drug: Buprenorphine +OTP

Buprenorphine+CHC

EXPERIMENTAL

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

Drug: Buprenorphine +CHC

Counseling + OTP

ACTIVE COMPARATOR

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

Drug: Counseling +OTP

Counseling + CHC

ACTIVE COMPARATOR

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

Drug: Counseling +CHC

Interventions

Buprenorphine +OTPDRUG

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

Also known as: Suboxone
Buprenorphine+OTP
Buprenorphine +CHCDRUG

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.

Also known as: Suboxone
Buprenorphine+CHC
Counseling +OTPDRUG

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.

Also known as: Suboxone
Counseling + OTP
Counseling +CHCDRUG

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.

Also known as: Suboxone
Counseling + CHC

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Metropolitan Transition Center

Baltimore, Maryland, 21201, United States

Location

Maryland Correctional Institution for Women

Jessup, Maryland, 20794, United States

Location

Related Publications (3)

  • 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.

    PMID: 20473351BACKGROUND

  • 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.

    PMID: 25392564BACKGROUND

  • 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.

    PMID: 31787108DERIVED

MeSH Terms

Conditions

Heroin Dependence

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Michael Gordon
Organization
Friends Research Institute
mgordon@friendsresearch.org
410-837-3977

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

September 1, 2008

Primary Completion

March 1, 2013

Study Completion

November 1, 2013

Last Updated

August 29, 2018

Results First Posted

April 11, 2016

Record last verified: 2018-07

Locations

US(2)