Relapse Prevention to Reduce HIV Among Women Prisoners

Phase 4

Completed

• Conditions: Opioid Dependence; HIV
• Interventions: Drug: Placebo; Drug: Buprenorphine

• Registration Number: NCT00763958
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-10-01
• Primary Completion: 2009-09
• Study Completion: 2010-09
• Results First Submitted: 2011-02-04
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-01
• Last Update Submitted: 2012-05-01
• Results First Posted: 2012-06-04
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo sublingual medication provided to individuals randomized to control up to 3 months
Buprenorphine	Buprenorphine	Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Enroll in the Study.	up to 24 months	To determine the number of participants who enroll in the study during the time of recruitment.