Relapse Prevention to Reduce HIV Among Women Prisoners

NCT ID: NCT00763958

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-09-30

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.

Conditions

Opioid Dependence; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Buprenorphine

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

Group Type: EXPERIMENTAL

Buprenorphine

Intervention Type: DRUG

Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match buprenorphine administered for 3 months

Interventions

Placebo

Placebo to match buprenorphine administered for 3 months

Intervention Type: DRUG

Buprenorphine

Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Karen Cropsey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

5R21DA019838-03

Identifier Type: NIH

Identifier Source: secondary_id

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7R21DA019838-02

Identifier Type: NIH

Identifier Source: secondary_id

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R21DA019838

Identifier Type: NIH

Identifier Source: org_study_id

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