Relapse Prevention to Reduce HIV Among Women Prisoners

Study Overview
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Brief Summary
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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
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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.

Official Title
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Relapse Prevention to Reduce HIV Among Women Prisoners

Conditions
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Opioid Dependence, HIV

Intervention / Treatment
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* Drug: Placebo
* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine<br>Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months | Drug: Buprenorphine<br>* Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.<br>|
| Placebo Comparator: Placebo<br>Placebo sublingual medication provided to individuals randomized to control up to 3 months | Drug: Placebo<br>* Placebo to match buprenorphine administered for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Enroll in the Study. | To determine the number of participants who enroll in the study during the time of recruitment. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opiates, HIV