Skip to main content
OpenTrials
Completed

NCT Number: NCT00763958

Relapse Prevention to Reduce HIV Among Women Prisoners

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Dependence Chemically-Induced Disorders HIV Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

19 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo to match buprenorphine administered for 3 months

buprenorphine

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 1, 2008
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.