Relapse Prevention to Reduce HIV Among Women Prisoners

HIV Clinical Trial

Official title:

Relapse Prevention to Reduce HIV Among Women Prisoners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763958
• Other study ID #: R21DA019838
• Secondary ID: 5R21DA019838-037
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2008
• Last updated: May 1, 2012
• Start date: May 2008
• Est. completion date: September 2010

Study information

• Verified date: May 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Opioid Dependence

Intervention

Drug:
• Placebo
Placebo to match buprenorphine administered for 3 months
• Buprenorphine
Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.	Number of participants with positive opiate urine samples at 12 weeks of treatment.	12 weeks	No
Primary	Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.	Number of participants with positive opiate urine sample at the 24 week follow-up.	24 weeks	No
Secondary	Number of Participants Who Enroll in the Study.	To determine the number of participants who enroll in the study during the time of recruitment.	up to 24 months	No