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Completed

NCT Number: NCT00574067

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.

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Key information

Conditions

Heroin Addiction Chemically-Induced Disorders Heroin Dependence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Metropolitan Transition Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Buprenorphine +OTP

Drug

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

Buprenorphine +CHC

Drug

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

Counseling +OTP

Drug

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

Counseling +CHC

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 14, 2007
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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