Relapse Prevention to Reduce HIV Among Women Prisoners

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: HIV; Opioid Dependence

Treatments: Drug: Placebo; Drug: Buprenorphine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00763958

5R21DA019838-03 (U.S. NIH Grant/Contract)

R21DA019838

7R21DA019838-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 19 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Buprenorphine

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo