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
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opiates, HIV
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.
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
NCT ID
NCT00763958
First Posted
September 29, 2008
Last Updated
May 1, 2012
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute on Drug Abuse (NIDA)
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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