MOUD Comparative Effectiveness Study

MOUD 比较效果研究

• 批准号: 10438884
• 负责人: Marc Larochelle
• 金额: $ 53.07万
• 依托单位: BOSTON MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10438884
• 关键词: Buprenorphine; Comparative Effectiveness Research; Data; Data Set; Data Sources; Databases; FDA approved; Formulation; Gold; Half-Life; Health Services Research; Incentives; Individual; Injectable; Intervention; Link; Massachusetts; Mediator of activation protein; Medical; Medicine; Morbidity - disease rate; Naltrexone; Observational Study; Opioid; Outcome; Outpatients; Participant; Patient Selection; Patients; Pharmaceutical Preparations; Policies; Population; Pragmatic clinical trial; Probability; Protocols documentation; Public Health; Randomized Clinical Trials; Randomized Controlled Trials; Risk; Structural Models; Suboxone; Techniques; Time; Weight; Work; active method; addiction; base; common treatment; comparative effectiveness; comparative effectiveness analysis; comparative effectiveness study; comparative effectiveness trial; compare effectiveness; contingency management; craving; data warehouse; high risk; illicit opioid; improved; improved outcome; mortality; novel; opioid mortality; opioid overdose; opioid use; opioid use disorder; opioid withdrawal; optimism; retention rate; standard of care; stem; treatment comparison; trial comparing; uptake

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.

项目摘要 阿片类药物过量死亡仍然处于危机水平;然而，有效药物的可获得性增加， 阿片类药物使用障碍（MOUD）是乐观的一个原因。不幸的是，MOUD没有得到充分利用。真实世界 数据已经确定了低MOUD保留率，与随机化中观察到的较高保留率形成对比。 对照试验（RCT）。虽然比较有效性RCT发现丁丙诺啡-纳洛酮和 缓释纳洛酮具有类似的保留和非法阿片类药物的使用，观察性研究发现， 致死性阿片类药物过量的发生率和丁丙诺啡-纳洛酮的保留改善。虽然RCT 被认为是研究因果关系的金标准，外部的普遍性是有限的，RCT 研究相对罕见的结果（如致命或非致命阿片类药物过量）的能力有限。的 马萨诸塞州公共卫生数据仓库（PHD）是一种新型的近人口级数据库， 超过20个基于州的数据集。博士学位提供了一个无与伦比的能力，研究广度 阿片类药物相关暴露和结局的深度，包括阿片类药物过量。目前的建议旨在 使用PHD模拟快速扩展的丁丙诺啡系列的目标比较有效性试验， 纳洛酮制剂。我们将研究阿片类药物脱毒后MOUD的启动， 为随后阿片类药物过量的高风险个体提供切入点。为了增进对 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：BOT RCT进行再分析， 丁丙诺啡-纳洛酮和缓释纳洛酮。使用PHD，我们将检查其他 结果，包括致命和非致命阿片类药物过量。我们将利用模拟审判框架 开发的目的是研究其他高优先级的比较有效性问题。我们将比较结果 从舌下丁丙诺啡-纳洛酮与丁丙诺啡缓释制剂开始 阿片类药物解毒后最后，虽然长期MOUD治疗是护理标准，但许多患者 我宁愿停止治疗。我们将评估3或6个月后逐渐减少舌下丁丙诺啡-纳洛酮的影响。 与继续使用相比，治疗时间为3个月。这些比较有效性分析的结果 将为政策和实践提供信息，说明不断扩大的MOUD公式的覆盖范围和使用情况。