Relapse Prevention to Reduce HIV Among Women Prisoners

May 1, 2012 updated by: Karen Cropsey, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DA019838 (U.S. NIH Grant/Contract)
  • 5R21DA019838-03 (U.S. NIH Grant/Contract)
  • 7R21DA019838-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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