BUPrenorphine Facilitated Access and Supportive Treatment--AIM 3
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Initiation of buprenorphine treatment
研究概览
简要总结
The goal of this study is to test whether peer mentors (i.e., individuals with past opioid addiction and prior incarceration) can facilitate entrance into buprenorphine (Suboxone) treatment for individuals with opioid use disorder who were recently released from jail or prison. In order to test whether it is helpful to have peer mentors paired with recently released individuals, the investigators will conduct an 18 month study, recruiting 72 formerly incarcerated individuals and assigning them by chance selection (like flipping a coin) to either a group that will receive peer mentorship or a group that will receive a referral to a community clinic.
详细描述
BUPrenorphine Facilitated Access and Supportive Treatment (BUP-FAST) is a peer mentorship intervention in which trained peer mentors will link formerly incarcerated individuals with opioid use disorder to addiction treatment (i.e. buprenorphine maintenance treatment) following release from incarceration. The current study is a pilot randomized control trial evaluating the effectiveness and feasibility of the peer mentorship intervention.
The investigators are conducting this study due to the high rates of relapse to opioid use following release from prison (up to 75% within 3 months) and difficulty that some formerly incarcerated individuals report in accessing effective treatments for opioid use disorder. The investigators hypothesize that having peer mentors - who themselves have experienced incarceration and have had success with buprenorphine treatment for opioid use disorder - assisting formerly incarcerated individuals in seeking treatment will result in higher rates of linkage to care in comparison to referral to a community health center for buprenorphine treatment.
In this 18-month randomized control trial of the BUP-FAST intervention, the investigators will recruit 72 formerly incarcerated individuals with opioid use disorder; half will then be randomized to receive the BUP-FAST intervention (peer mentorship); and the other half (control) will receive referral to a community health center for assessment for buprenorphine treatment. Medication will not be provided as part of this study. Participants will only receive buprenorphine treatment if they meet appropriate medical criteria after assessment at the community health center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current or prior (at the time of incarceration) opioid use disorder by DSM-V criteria
- •≥ 18 years old
- •Fluent in English or Spanish
- •Released from incarceration in the last 4 weeks
排除标准
- •Current buprenorphine or methadone maintenance treatment
研究组 & 干预措施
Referral to treatment (Control)
The control group will receive a referral to buprenorphine treatment by the research staff.
干预措施: Referral to treatment (Behavioral)
BUP-FAST Intervention
Thirty-six participants will each be paired with a trained peer mentor who will provide the BUP-FAST intervention.
干预措施: BUP_FAST (Behavioral)
结局指标
主要结局
Initiation of buprenorphine treatment
时间窗: At 180 days post enrollment
Initiation of buprenorphine treatment within 180 days of study enrollment will be confirmed by reviewing the patient's medical records. Participants will sign a release for protected health information in order to confirm buprenorphine induction and visits. Initiation of buprenorphine treatment will be defined as receiving one or more prescription for buprenorphine or buprenorphine-naloxone.
次要结局
- Criminal activity(At 45 days post enrollment)
- Opioid use (self-reported)(At 45 days post enrollment)
- Opioid use (urine drug testing)(At 45 days post enrollment)
研究者
Aaron D. Fox
Assistant Professor of Medicine
Montefiore Medical Center