Conditions: Opioid Dependence HIV
Keywords: opiates HIV
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 44
Healthy volunteers: yes

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.

Arms:
arm 1: Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months arm 2: Placebo sublingual medication provided to individuals randomized to control up to 3 months

Interventions: intervention 1: Placebo intervention 2: Buprenorphine
Intervention descriptions: intervention 1: Placebo to match buprenorphine administered for 3 months intervention 2: Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.

Protocol document: