Buprenorphine for Prisoners

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00574067
First received: December 12, 2007
Last updated: March 11, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Heroin Addiction
Drug: Buprenorphine +OTP
Drug: Buprenorphine +CHC
Drug: Counseling +OTP
Drug: Counseling +CHC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Buprenorphine for Prisoners

Resource links provided by NLM:


Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Number of Days of Heroin Use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    mean days used heroin during the past 30 days

  • Drug Abuse Treatment Entry and Retention in the Community [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    entered community treatment within 10 days of release from prison (yes vs. no)


Secondary Outcome Measures:
  • Number of Days of Cocaine Use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of days used cocaine during the past 30 days.

  • Criminal Activity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Days of crime during the past 30 days

  • Employment Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of days employed during the past year

  • HIV Risk Behavior Needle Sharing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of times shared a needle during the past year

  • HIV Risk Behavior [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of times had sex without using a condom during the past year


Enrollment: 213
Study Start Date: September 2008
Study Completion Date: November 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574067

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:
Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00574067     History of Changes
Other Study ID Numbers: 1RO1DA021579-01A1  R01DA021579 
Study First Received: December 12, 2007
Results First Received: August 11, 2015
Last Updated: March 11, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Heroin Dependence
Opioid-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

ClinicalTrials.gov processed this record on July 24, 2016