Relapse Prevention to Reduce HIV Among Women Prisoners
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •history of opioid dependence,
- •released back to the community from a controlled environment,
- •criminal justice involvement.
排除标准
- •under age 19,
- •medical contraindications,
- •major psychiatric problems.
研究组 & 干预措施
Buprenorphine
Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months
干预措施: Buprenorphine (Drug)
Placebo
Placebo sublingual medication provided to individuals randomized to control up to 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.
时间窗: 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.
时间窗: 24 weeks
Number of participants with positive opiate urine sample at the 24 week follow-up.
次要结局
- Number of Participants Who Enroll in the Study.(up to 24 months)
研究者
Karen Cropsey
Associate Professor
University of Alabama at Birmingham