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Clinical Trials/NCT00574067
NCT00574067
Completed
Phase 3

Buprenorphine for Prisoners

Friends Research Institute, Inc.2 sites in 1 country213 target enrollmentSeptember 2008

Overview

Phase
Phase 3
Intervention
Buprenorphine +OTP
Conditions
Heroin Addiction
Sponsor
Friends Research Institute, Inc.
Enrollment
213
Locations
2
Primary Endpoint
Number of Days of Heroin Use
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
November 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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 -

Arms & Interventions

Buprenorphine+OTP

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

Intervention: Buprenorphine +OTP

Buprenorphine+CHC

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

Intervention: Buprenorphine +CHC

Counseling + OTP

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

Intervention: Counseling +OTP

Counseling + CHC

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

Intervention: Counseling +CHC

Outcomes

Primary Outcomes

Number of Days of Heroin Use

Time Frame: 1 year

mean days used heroin during the past 30 days

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 Outcomes

  • Criminal Activity(1 year)
  • Employment Status(1 year)
  • HIV Risk Behavior Needle Sharing(1 year)
  • Number of Days of Cocaine Use(1 year)
  • HIV Risk Behavior(1 year)

Study Sites (2)

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