Relapse Prevention to Reduce HIV Among Women Prisoners
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|ClinicalTrials.gov Identifier: NCT00763958|
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : June 4, 2012
Last Update Posted : June 4, 2012
University of Alabama at Birmingham
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham
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.
|Condition or disease||Intervention/treatment||Phase|
|Opioid Dependence HIV||Drug: Placebo Drug: Buprenorphine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Relapse Prevention to Reduce HIV Among Women Prisoners|
|Study Start Date :||May 2008|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2010|
Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months
Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
Placebo Comparator: Placebo
Placebo sublingual medication provided to individuals randomized to control up to 3 months
Placebo to match buprenorphine administered for 3 months
Primary Outcome Measures :
- 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.
- 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 Outcome Measures :
- 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.
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