MOUD Comparative Effectiveness Study

项目总结 阿片类药物过量死亡人数仍处于危机水平；然而，有效药物的增加有助于 阿片类药物使用障碍(Moud)是乐观的原因之一。不幸的是，Moud没有得到充分利用。现实世界 数据表明，Moud保留率较低，而随机调查中观察到的保留率较高 对照试验(RCT)。而比较疗效的RCT发现丁丙诺啡-纳洛酮和 缓释纳曲酮具有类似的滞留和非法阿片类药物使用，观察性研究发现较低 致命性阿片类药物过量和丁丙诺啡-纳洛酮改善滞留的比率。而RCT则是 被认为是研究因果关系的黄金标准，外部概括性是有限的，RCT 研究相对罕见的结果，如致命或非致命的阿片类药物过量的能力有限。这个 马萨诸塞州公共卫生数据仓库(PHD)是一个新的接近人口级别的数据库，它将更多的 在个人层面上有20多个基于州的数据集。博士学位提供了无与伦比的研究广度的能力 与阿片类药物相关的暴露和结果的深度，包括阿片类药物过量。目前的提案旨在 使用PHD模拟快速扩张的丁丙诺啡和丁丙诺啡的靶向比较有效性试验 纳曲酮制剂。我们将检查阿片类药物脱毒后的Moud启动，这是一种常见的治疗方法 随后阿片类药物过量的高危人群的切入点。以增进对 观察性研究和随机对照试验之间的差异我们将直接比较治疗的效果估计 通过对目标X的重新分析，在PHD的模拟试验中保留：BOT RCT，比较语下 丁丙诺啡-纳洛酮和缓释纳曲酮。使用博士学位，我们将检查其他 结果，包括致命和非致命的阿片类药物过量。我们将利用模拟试验框架 开发的目的是研究额外的高优先级比较有效性问题。我们将比较结果 丁丙诺啡-纳洛酮舌下含服缓释剂与丁丙诺啡缓释剂的比较 在阿片类药物戒毒之后。最后，虽然长期的Moud治疗是护理的标准，但许多患者 更愿意停止治疗。我们将在3或6个月后评估逐渐减少舌下含丁丙诺啡-纳洛酮的影响 治疗数月与继续使用进行比较。这些比较有效性分析的结果 将向政策和实践提供关于扩大Moud配方的覆盖面和使用的信息。

PROJECT SUMMARY Opioid overdose deaths remain at crisis levels; however, increasing availability of effective medications for opioid use disorder (MOUD) are one reason for optimism. Unfortunately, MOUD are underutilized. Real-world data have identified low MOUD retention rates in contrast with higher retention rates observed in randomized controlled trials (RCTs). While comparative effectiveness RCTs found that buprenorphine-naloxone and extended-release naltrexone have similar retention and illicit opioid use, observational studies identify lower rates of fatal opioid overdose and improved retention with buprenorphine-naloxone. While RCTs are considered the gold standard for studying causal relationships, external generalizability is limited, and RCTs have limited power to study relatively rare outcomes such as fatal or nonfatal opioid overdose. The Massachusetts Public Health Data warehouse (PHD) is a novel near population-level database linking more than 20 state-based datasets at the individual level. The PHD offers an unparalleled ability to study a breadth and depth of opioid-related exposures and outcomes, including opioid overdose. The current proposal seeks to use PHD to emulate target comparative effectiveness trials of a rapidly expanding array of buprenorphine and naltrexone formulations. We will examine MOUD initiation following opioid detoxification, a common treatment entry point for individuals at high-risk for subsequent opioid overdose. To advance understanding of the differences between observational studies and RCTs we will directly compare effect estimates of treatment retention from an emulated trial in PHD with a reanalysis of the target X:BOT RCT that compared sublingual buprenorphine-naloxone and extended-release naltrexone. Using the PHD, we will examine additional outcomes, including fatal and nonfatal opioid overdose. We will leverage the emulated trial framework developed to study additional high priority comparative effectiveness questions. We will compare outcomes from initiation of sublingual buprenorphine-naloxone versus buprenorphine extended-release formulations following opioid detoxification. Finally, while long-term MOUD treatment is the standard of care, many patients prefer to stop treatment. We will assess the impact of tapering sublingual buprenorphine-naloxone after 3 or 6 months of treatment compared with continued use. The findings of these comparative effectiveness analyses will inform policy and practice on the coverage and use of an expanding array of MOUD formulations.