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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Placebo to match buprenorphine administered for 3 months
Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
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.
Time frame: 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.
Time frame: 24 weeks
Number of Participants Who Enroll in the Study.
To determine the number of participants who enroll in the study during the time of recruitment.
Time frame: up to 24 months
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