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Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release

Primary Purpose

Opiate Addiction

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
buprenorphine
methadone
Sponsored by
National Development and Research Institutes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Addiction focused on measuring addiction, jail, opiates, buprenorphine, clinical trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: opioid dependent patients who meet eligibility requirements for the KEEP program, patients serving sentences who will remain confined for at least 10 days but less than 90 days in the EMTC facility (all male) at Rikers, willingness to accept buprenorphine treatment, expected to reside in New York City after release 18-65 years of age Exclusion Criteria: receiving methadone treatment in the community at sentencing and remanded to Rikers took non-prescribed 'street methadone' within last 3 days currently receiving more than 20mg/day methadone current psychotic symptoms (e.g., schizophrenia, schizoaffective disorder) requiring referral for mental health intervention, or current treatment with antipsychotic medication) HIV infection with T lymphocytes less than 200 per mm of blood and/or presence of a serious opportunistic infection requiring treatment, or receiving the HIV medication atazanavir. unable to complete English language interview

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Buprenorphine maintenance

    Methadone maintenance

    Outcomes

    Primary Outcome Measures

    Treatment completion in jail
    Reporting to assigned treatment modality after release

    Secondary Outcome Measures

    Intention to continue treatment after release
    Re-incarceration
    Frequency of illicit opioid use after release
    Re-arrest
    Severity of re-arrest charges
    Satisfaction with opioid replacement treatment.
    Opioid withdrawal symptoms and cravings

    Full Information

    First Posted
    August 21, 2006
    Last Updated
    April 30, 2013
    Sponsor
    National Development and Research Institutes, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA), Western Michigan University, New York City Department of Health and Mental Hygiene
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00367302
    Brief Title
    Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
    Official Title
    Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Development and Research Institutes, Inc.
    Collaborators
    National Institute on Drug Abuse (NIDA), Western Michigan University, New York City Department of Health and Mental Hygiene

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release.
    Detailed Description
    Background: Heroin and other opioid abuse continues as a significant problem among the criminal justice population. In 2002, the criminal justice system was the source of referral for 36% of all substance abuse treatment admissions, the largest source of referrals. Heroin use among offenders has serious health and social consequences. Injection, still the primary route of administration among heroin users, is strongly associated with the transmission of HIV, hepatitis C and other blood-borne diseases. During 1997, 20% to 26% of all people living with HIV in the United States, and 29% to 43% of all those infected with hepatitis C, passed through a correctional facility. The relationship between heroin use and criminal activity has been extensively documented. Although methadone maintenance has been the primary treatment for chronic opioid dependence since the 1970's, correctional systems in the U.S., with very few exceptions (primarily Rikers Island in New York City), have not provided institutional access to methadone maintenance. Regrettably, negative attitudes to methadone are prevalent among criminal justice professionals, the public, treatment providers and opioid-dependent offenders themselves; there is little prospect of that changing soon. Buprenorphine maintenance is a recently approved therapy that may be more acceptable than methadone to the criminal justice system and opioid-dependent offenders. With one minor exception, buprenorphine has never been systematically administered as an opioid replacement therapy in a correctional setting in the U.S. Aims and Objectives: To determine the feasibility of providing buprenorphine maintenance to opioid-dependent offenders in a jail setting and of transitioning those patients to buprenorphine maintenance in the community after their release. To conduct a randomized clinical trial of buprenorphine maintenance (N=50) vs. methadone maintenance (N=50) initiated in the jail setting and continuing in the community. To determine the reasons that offenders fail to report for community buprenorphine or methadone treatment after release or drop out of community treatment. Study Design: Consenting eligible inmates at Rikers Island in New York City will be randomly assigned to buprenorphine or methadone maintenance in jail and will be referred to a corresponding community treatment upon their release. Subjects will be followed-up at 3 months after release from jail. Target Population: Opioid-dependent jail inmates sentenced to 10- 90 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opiate Addiction
    Keywords
    addiction, jail, opiates, buprenorphine, clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    116 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Buprenorphine maintenance
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Methadone maintenance
    Intervention Type
    Drug
    Intervention Name(s)
    buprenorphine
    Other Intervention Name(s)
    Suboxone
    Intervention Description
    maintenance
    Intervention Type
    Drug
    Intervention Name(s)
    methadone
    Intervention Description
    maintenance
    Primary Outcome Measure Information:
    Title
    Treatment completion in jail
    Time Frame
    Until release from jail
    Title
    Reporting to assigned treatment modality after release
    Time Frame
    Within 3 months after release from jail
    Secondary Outcome Measure Information:
    Title
    Intention to continue treatment after release
    Time Frame
    At release from jail
    Title
    Re-incarceration
    Time Frame
    Within 3 months after release
    Title
    Frequency of illicit opioid use after release
    Time Frame
    Within 3 months after release
    Title
    Re-arrest
    Time Frame
    Within 3 months after release
    Title
    Severity of re-arrest charges
    Time Frame
    Within 3 months after release, if re-arrested
    Title
    Satisfaction with opioid replacement treatment.
    Time Frame
    During jail and 3 months post-release
    Title
    Opioid withdrawal symptoms and cravings
    Time Frame
    During jail and post-release

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: opioid dependent patients who meet eligibility requirements for the KEEP program, patients serving sentences who will remain confined for at least 10 days but less than 90 days in the EMTC facility (all male) at Rikers, willingness to accept buprenorphine treatment, expected to reside in New York City after release 18-65 years of age Exclusion Criteria: receiving methadone treatment in the community at sentencing and remanded to Rikers took non-prescribed 'street methadone' within last 3 days currently receiving more than 20mg/day methadone current psychotic symptoms (e.g., schizophrenia, schizoaffective disorder) requiring referral for mental health intervention, or current treatment with antipsychotic medication) HIV infection with T lymphocytes less than 200 per mm of blood and/or presence of a serious opportunistic infection requiring treatment, or receiving the HIV medication atazanavir. unable to complete English language interview
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephen Magura, Ph.D.
    Organizational Affiliation
    Western Michigan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Buprenorphine Maintenance for Opioid-Addicted Persons in Jail and Post-Release

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