A comparison of Sublingual and Extended-Release Buprenorphine for Individuals Leaving Jail

摘要 拟议的研究包括在母研究中增加一个准对照组，其中120 在监狱中接受舌下丁丙诺啡（SL-B）的被监禁男女将被要求 通过继续在社区接受丁丙诺啡治疗并完成以下活动来参与- 在释放后12个月内进行评估（治疗发生在第1-7个月，12个月随访， 仅上）。将该准对照组与随机分配至BRIXADI组的受试者进行比较 （缓释丁丙诺啡，XR-B）。倾向分数将用于 允许通过倾向得分加权广义线性混合模型进行因果建模。 将使用HEAL JCOIN通用指标促进数据协调和交叉研究 分析。我们计划与惩教管理人员进行半结构化访谈， 惩教人员和监狱卫生服务提供者（N=25），以了解有关 促进SL-B的实施。我们计划利用目前参与我们的监狱， 治愈JCOIN R 01已经提供SL-B和Bill-116的初始队列的一部分。的 研究有三个具体目标：目标1。确定XR-B与SL-B相比的有效性 在（a）药物治疗依从性（丁丙诺啡治疗天数）方面，B）非法阿片类药物 尿检结果;（c）自我报告的非法类阿片使用;（d）过量事件（非致命性和致命性）;（e） 生活质量（一）身体健康; ii.（f）艾滋病毒危险行为（i.性行为; ii. 使用或共用针头）;及（g）犯罪活动（i.犯罪日; ii.再次逮捕; iii.再次入狱）。 目标2.探讨监狱实施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）释放或转送到 （4）每日丁丙诺啡给药的人员配备（监管和医疗）需求; 以及（5）验证来自社区的个体的剂量的过程 被捕后的维修计划。目标3.（a）计算矫正费用 实施和维持SL-B或XR-B计划的卫生系统（XR-B成本正在 在母试验中计算，但需要对新研究中心进行估计）;以及（B）确定 XR-B与SL-B相比的相对价值，包括随后的社区治疗费用， 从国家决策者和社会的角度来看。这项研究意义重大，因为 大多数OUD患者在监狱中没有接受丁丙诺啡治疗， 大大增加了他们复吸吸毒、吸毒过量死亡和再次入狱的可能性。 最后，重要的是要了解不同的治疗方式（每月延长- 释放注射与每日口服剂量）及其现实世界的实施影响 药物治疗依从性和阿片类药物相关危害。

Abstract The proposed study consists of adding a quasi-control arm to the parent study wherein 120 incarcerated men and women receiving sublingual buprenorphine (SL-B) in jail will be asked to participate by continuing their buprenorphine treatment in the community and completing follow- up assessments over 12 months post-release (treatment occurs months 1-7, 12-month follow- up only). This quasi-control arm will be compared to participants randomized to BRIXADI (extended-release buprenorphine, XR-B) in the parent study. Propensity scores will be used to permit causal modeling by way of propensity score weighted generalized linear mixed models. HEAL JCOIN common measures will be utilized to facilitate data harmonization and cross-study analyses. We plan to conduct semi-structured interviews with correctional administrators, correctional officers; and jail health providers (N=25) to understand issues regarding barriers to facilitating SL-B implementation. We plan to use the jails that are currently participating in our HEAL JCOIN R01 that are already providing SL-B and part of the initial cohort of Bill-116. The study has three specific aims: Aim 1. To determine the effectiveness of XR-B compared to SL-B in terms of (a) pharmacotherapy adherence (days in buprenorphine treatment), b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. Explore barriers and facilitators to 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 buprenorphine dosing; and (5) the process of verifying the dosage of an individual coming from a community maintenance program after being arrested. Aim 3. To (a) calculate the cost to the correctional health system of implementing and sustaining an SL-B or XR-B program (XR-B costs are being calculated in parent trial but will need to be estimated for new sites); and (b) determine the relative value of XR-B compared to SL-B, including the subsequent community treatment costs, from a state-policymaker and societal perspective. The study will be highly significant because most individuals with OUD do not receive buprenorphine treatment while in jail, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Finally, it is important to understand how differing treatment modalities (monthly extended- release injections vs. daily oral doses) and their real-world implementations affect pharmacotherapy adherence and opioid related harms.