A comparative effectiveness trial of sublingual versus extended-release buprenorphine with individuals leaving a carceral setting

摘要 虽然先前的研究已经证明了阿片类药物使用障碍的有效性 在监禁期间，全国很少采用这种做法。延长释放 丁丙诺啡（XR-B）是一种有希望的用于治疗宫颈环境中OUD的干预。个人 重新进入社区的OUD因阿片类药物复发而过量和死亡的风险增加 与其他阿片类药物相关的危害。这项建议是根据目前调查人员的经验， 使用XR-B和舌下丁丙诺啡-纳洛酮（SL-B）对监狱中的个人进行临床试验。 这项拟议的研究是一项在大都市监狱进行的XR-B与SL-B的随机对照试验。一项开放标签 设计将随机分配240名患有中度至重度OUD的成年人，他们即将从监狱释放， 在监狱中接受XR-B（n = 120）或SL-B（n = 120）治疗，然后在释放后接受6个月的丁丙诺啡治疗 治疗、7个月安全性访视和12个月最终长期随访。该研究有三个目标：目标1。 比较XR-B与SL-B在以下方面的有效性：主要结局。(a)非法使用阿片类药物（i.尿液 毒理学; ii.使用时间轴随访的自我报告的阿片类药物使用天数;以及iii.阿片类药物复发时间）。 次要结局。(b)丁丙诺啡治疗中的保留（i.接受丁丙诺啡的天数和ii.时间 治疗中途退出）;（c）其他非法药物使用（i.尿毒理学; ii.自我报告的非法药物使用天数 使用时间轴随访;（d）过量事件（非致命性和致命性）;（e）生活质量（即，身体健康; ii. （f）艾滋病毒危险行为（i.性风险行为; ii.使用或共用针头）;以及（g）犯罪活动 （一）犯罪日; ii.再次逮捕; iii.技术违规;四.再次入狱）。目标二。来计算州政府的成本 和/或监狱/城市卫生系统实施XR-B和SL-B，并确定相对值，包括 县和州政策制定者以及社会与社区干预相关的成本 perspective.目标3：探索监狱中实施XR-B/SL-B的障碍和促进因素：（1）剂量诱导;（2） 转送和减少转送的程序;（3）释放或转送他人后的照料连续性 设施;（4）每日与XR-B丁丙诺啡给药的人员配备（监护和医疗）需求;以及（5） 患者对XR-B的偏好与SL-B相比。拟议的研究将是创新的，因为它将是第一个 在美国开展的一项大规模随机对照试验，评估XR-B与SL-B在个体中的有效性和成本效益 重新融入社会的人了解如何在监狱中扩大丁丙诺啡的接受度， 对扩大监狱中的治疗有着深远的影响。

Abstract Although previous research has demonstrated the effectiveness of initiating medications for opioid use disorder (MOUDs) during incarceration, there has been very little adoption nationwide of this practice. Extended-release buprenorphine (XR-B) is a promising intervention for the treatment of OUDs in carceral settings. Individuals with OUDs re-entering the community are at an elevated risk for overdose and death from relapse to opioid use among other opioid-related harms. This proposal builds on the current investigators experience conducting clinical trials using both XR-B and sublingual-buprenorphine-naloxone (SL-B) with individuals in jail and prison. This proposed study is a randomized controlled trial of XR-B vs. SL-B in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n = 120) or SL-B (n = 120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and final long-term follow-up at 12-months. The study has three aims: Aim 1. Compare the effectiveness of XR-B vs. SL-B in terms of: Primary Outcome. (a) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use using Timeline Followback; and iii. time to opioid relapse). Secondary Outcomes. (b) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use using Timeline Followback; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration). Aim 2. To calculate the cost to the state and/or jail/city health system of implementing XR-B and SL-B, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective. Aim 3. Explore barriers and facilitators to XR-B/SL-B implementation in jail: (1) dose induction; (2) diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another facility; (4) staffing (both custody and medical) needs for daily versus XR-B buprenorphine dosing; and (5) patient preference for XR-B versus SL-B. The proposed study would be innovative because it would be the first large scale RCT in the US assessing effectiveness and cost effectiveness of XR-B versus SL-B with individuals in a jail who are re-entering community. Understanding how to expand acceptance of buprenorphine in jails, has far-reaching implications for expanding treatment access in jail.