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

摘要 尽管先前的研究已经证明了开始用药治疗阿片类药物使用障碍的有效性 (穆兹)在监禁期间，全国范围内很少采用这种做法。延期发行版 丁丙诺啡(XR-B)是一种很有前途的治疗顽固性尿失禁的干预药物。个人 随着ODS重新进入社区，过量服药和因阿片类药物复发而死亡的风险增加 在其他与阿片类药物相关的危害中使用。这项建议建立在当前调查人员进行 使用XR-B和舌下-丁丙诺啡-纳洛酮(SL-B)的临床试验在监狱和监狱中的个人。 这项拟议的研究是在一个大型大都市监狱中进行的XR-B和SL-B的随机对照试验。一个开放的标签 Design将随机将240名即将出狱的患有中到重度OUD的成年人分配到 XR-B(n=120)或SL-B(n=120)在监狱接受治疗，然后在释放后6个月丁丙诺啡 治疗，7个月的安全访问，并在12个月时进行最后的长期随访。这项研究有三个目标：目标1。 比较XR-B和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(一、尿液 毒理学；ii.使用Timeline Followback自我报告的阿片类药物使用天数；阿片类药物复发的时间到了)。 次要结果。(B)丁丙诺啡保留治疗(一.丁丙诺啡治疗天数和二.时间到了 (C)其他非法物质的使用(一、尿毒学；二.自我报告的非法物质天数 使用时间线回传；(D)服药过量事件(非致命和致命)；(E)生活质量(一、身体健康；二. (F)艾滋病毒危险行为(一.性危险行为；二.针头使用或共用)；和(G)犯罪活动 (一)犯罪天数；二.再次逮捕；3.(四)技术违法；重新监禁)。目标2.计算给国家带来的成本 和/或监狱/城市卫生系统实施XR-B和SL-B，并确定相对价值，包括 与社区干预相关的成本，来自县和州的政策制定者和社会 透视。目的3.探索在监狱中实施XR-B/SL-B的障碍和促进者：(1)剂量诱导；(2) 转移和减少转移的程序；(3)释放或转移到另一人后的持续护理 设施；(4)每日丁丙诺啡剂量与XR-B丁丙诺啡剂量的人员配备(监护和医疗)需求；以及(5) 患者对XR-B和SL-B的偏好拟议的研究将是创新的，因为它将是第一次 美国大规模随机对照试验评估XR-B与SL-B的个人效果和成本效益 在监狱里，他们正在重新进入社区。了解如何扩大监狱对丁丙诺啡的接受度， 对扩大监狱中的治疗机会具有深远的影响。

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.