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

摘要 尽管之前的研究已经证明了启动药物治疗阿片类药物使用障碍的有效性 （MOUD）在监禁期间，全国范围内很少采用这种做法。缓释 丁丙诺啡 (XR-B) 是一种很有前途的治疗监狱中 OUD 的干预措施。个人 随着 OUD 重新进入社区，阿片类药物复发导致用药过量和死亡的风险升高 使用其他与阿片类药物相关的危害。该提案建立在当前研究人员进行的经验基础上 使用 XR-B 和舌下含服丁丙诺啡纳洛酮 (SL-B) 对监狱和监狱中的个人进行临床试验。 这项拟议的研究是在一座大型城市监狱中进行的 XR-B 与 SL-B 的随机对照试验。开放标签 设计将随机分配 240 名即将出狱的中度至重度 OUD 成年人 在监狱中接受 XR-B (n = 120) 或 SL-B (n = 120) 治疗，随后在释放后接受 6 个月的丁丙诺啡治疗 治疗、7 个月的安全性访视以及 12 个月的最终长期随访。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： 主要结果。 (a) 非法使用阿片类药物（即尿液 毒理学；二.使用时间线追踪自我报告阿片类药物使用天数；和 iii.阿片类药物复发的时间）。 次要成果。 (b) 丁丙诺啡治疗的保留（i. 接受丁丙诺啡的天数，ii. 接受丁丙诺啡的时间） 治疗退出）； (c) 其他非法物质使用（i. 尿液毒理学；ii. 自我报告的非法物质使用天数 使用Timeline Followback； (d) 用药过量事件（非致命和致命）； (e) 生活质量（i. 身体健康；ii. 心理健康）； (f) 艾滋病毒危险行为（i. 性危险行为；ii. 使用或共用针头）； (g) 犯罪活动 （i. 犯罪日；ii. 再次逮捕；iii. 技术违规；iv. 再次监禁）。目标 2. 计算国家的成本 和/或实施 XR-B 和 SL-B 的监狱/城市卫生系统，并确定相对值，包括 与社区干预相关的成本，来自县和州政策制定者以及社会 观点。目标 3. 探索 XR-B/SL-B 在监狱中实施的障碍和促进因素：(1) 剂量诱导； (2) 转移和减少转移的程序； (3) 释放或转移到另一个人后继续护理 设施； (4) 每日剂量与 XR-B 丁丙诺啡剂量的人员配置（监管和医疗）需求；和（5） 患者对 XR-B 与 SL-B 的偏好。拟议的研究将具有创新性，因为它将是第一个 美国开展的大规模随机对照试验，评估 XR-B 与 SL-B 的个人有效性和成本效益 正在监狱里重新进入社区的人。了解如何扩大监狱中对丁丙诺啡的接受程度， 对于扩大监狱治疗机会具有深远影响。

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.