Ignite Creation Date:
2025-12-17 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 1:14 AM
Study NCT ID:
NCT00763958
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2008-09-29
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Relapse Prevention to Reduce HIV Among Women Prisoners
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Relapse Prevention to Reduce HIV Among Women Prisoners
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R21DA019838-03 | NIH | None | https://reporter.nih.gov/quic… | View |
| 7R21DA019838-02 | NIH | None | https://reporter.nih.gov/quic… | View |