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Relapse Prevention to Reduce HIV Among Women Prisoners

Primary Purpose

Opioid Dependence, HIV

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
Buprenorphine
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence focused on measuring opiates, HIV

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • female,
  • history of opioid dependence,
  • released back to the community from a controlled environment,
  • criminal justice involvement.

Exclusion Criteria:

  • under age 19,
  • medical contraindications,
  • major psychiatric problems.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Buprenorphine

    Placebo

    Arm Description

    Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months

    Placebo sublingual medication provided to individuals randomized to control up to 3 months

    Outcomes

    Primary Outcome Measures

    Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
    Number of participants with positive opiate urine samples at 12 weeks of treatment.
    Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.
    Number of participants with positive opiate urine sample at the 24 week follow-up.

    Secondary Outcome Measures

    Number of Participants Who Enroll in the Study.
    To determine the number of participants who enroll in the study during the time of recruitment.

    Full Information

    First Posted
    September 29, 2008
    Last Updated
    May 1, 2012
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00763958
    Brief Title
    Relapse Prevention to Reduce HIV Among Women Prisoners
    Official Title
    Relapse Prevention to Reduce HIV Among Women Prisoners
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.
    Detailed Description
    This study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially, 9 women were enrolled and received buprenorphine medication. After the first 9 participants, women were randomized to either buprenorphine or placebo. Women received the buprenorphine medication for 12 weeks in the community and at the end of the 12 weeks were transitioned either to another buprenorphine provider, methadone provider, or tapered off buprenorphine based on the participant's preferences. One additional follow-up at 3 months after treatment was conducted. The primary outcome was opioid positive urines at all time points.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Dependence, HIV
    Keywords
    opiates, HIV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Buprenorphine
    Arm Type
    Experimental
    Arm Description
    Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo sublingual medication provided to individuals randomized to control up to 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to match buprenorphine administered for 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Buprenorphine
    Intervention Description
    Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
    Primary Outcome Measure Information:
    Title
    Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
    Description
    Number of participants with positive opiate urine samples at 12 weeks of treatment.
    Time Frame
    12 weeks
    Title
    Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.
    Description
    Number of participants with positive opiate urine sample at the 24 week follow-up.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Participants Who Enroll in the Study.
    Description
    To determine the number of participants who enroll in the study during the time of recruitment.
    Time Frame
    up to 24 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: female, history of opioid dependence, released back to the community from a controlled environment, criminal justice involvement. Exclusion Criteria: under age 19, medical contraindications, major psychiatric problems.

    12. IPD Sharing Statement

    Learn more about this trial

    Relapse Prevention to Reduce HIV Among Women Prisoners

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