Relapse Prevention to Reduce HIV Among Women Prisoners
Overview
- Phase
- Phase 4
- Intervention
- Buprenorphine
- Conditions
- Opioid Dependence
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 44
- Primary Endpoint
- Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Karen Cropsey
Associate Professor
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •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.
Arms & Interventions
Buprenorphine
Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months
Intervention: Buprenorphine
Placebo
Placebo sublingual medication provided to individuals randomized to control up to 3 months
Intervention: Placebo
Outcomes
Primary Outcomes
Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
Time Frame: 12 weeks
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.
Time Frame: 24 weeks
Number of participants with positive opiate urine sample at the 24 week follow-up.
Secondary Outcomes
- Number of Participants Who Enroll in the Study.(up to 24 months)