Phase 4
N=44
Relapse Prevention to Reduce HIV Among Women Prisoners
Opioid Dependence · HIV
Bottom Line
View on ClinicalTrials.gov: NCT00763958 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. — 14; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Buprenorphine (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opiate Positive Urines With Missing Urines Coded as Positive at Week 12. |
14; 5 | — |
| PRIMARY Opiate Positive Urines With Missing Urines Coded as Positive at Week 24. |
4; 4 | — |
| SECONDARY Number of Participants Who Enroll in the Study. |
28; 16 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00763958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.