Relapse Prevention to Reduce HIV Among Women Prisoners
3 other identifiers
interventional
44
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2008
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 29, 2008
CompletedFirst Posted
Study publicly available on registry
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
June 4, 2012
CompletedJune 4, 2012
May 1, 2012
1.3 years
September 29, 2008
February 4, 2011
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (1)
Number of Participants Who Enroll in the Study.
up to 24 months
Study Arms (2)
Buprenorphine
EXPERIMENTALActive sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months
Placebo
PLACEBO COMPARATORPlacebo sublingual medication provided to individuals randomized to control up to 3 months
Interventions
Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
Eligibility Criteria
You may qualify if:
- female,
- history of opioid dependence,
- released back to the community from a controlled environment,
- criminal justice involvement.
You may not qualify if:
- under age 19,
- medical contraindications,
- major psychiatric problems.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Slow recruitment with poor retention. Transient population that was difficult to effectively track.
Results Point of Contact
- Title
- Dr. Karen Cropsey
- Organization
- University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 29, 2008
First Posted
October 1, 2008
Study Start
May 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2010
Last Updated
June 4, 2012
Results First Posted
June 4, 2012
Record last verified: 2012-05