MOUD Comparative Effectiveness Study

MOUD 比较效果研究

基本信息

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
项目类别：
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

项目摘要

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.

项目概要阿片类药物过量死亡人数仍处于危机水平；然而，有效药物的供应不断增加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。现实世界数据显示 MOUD 保留率较低，而随机试验中观察到的保留率较高对照试验（RCT）。虽然比较有效性随机对照试验发现丁丙诺啡-纳洛酮和缓释纳曲酮具有类似的保留和非法阿片类药物的使用，观察性研究发现较低致命的阿片类药物过量的发生率和改善丁丙诺啡-纳洛酮的保留率。虽然随机对照试验是被认为是研究因果关系的黄金标准，外部普遍性有限，并且随机对照试验研究相对罕见的结果（例如致命或非致命的阿片类药物过量）的能力有限。这马萨诸塞州公共卫生数据仓库 (PHD) 是一个新颖的接近人口水平的数据库，链接更多信息超过 20 个基于州的个人级别数据集。博士学位提供了无与伦比的研究广度的能力阿片类药物相关暴露和结果的深度，包括阿片类药物过量。目前的提案旨在使用 PHD 模拟一系列快速扩展的丁丙诺啡和目标比较有效性试验纳曲酮制剂。我们将检查阿片类药物戒毒（一种常见的治疗方法）后 MOUD 的启动情况后续阿片类药物过量使用的高风险个体的切入点。为了加深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一项 PHD 模拟试验的保留，重新分析目标 X:BOT RCT，比较舌下含服丁丙诺啡-纳洛酮和缓释纳曲酮。利用博士学位，我们将研究更多后果，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用于研究其他高度优先的比较有效性问题。我们将比较结果从舌下含服丁丙诺啡-纳洛酮与丁丙诺啡缓释制剂开始比较阿片类药物解毒后。最后，虽然长期 MOUD 治疗是护理标准，但许多患者宁愿停止治疗。我们将在 3 或 6 次后评估逐渐减少舌下含服丁丙诺啡-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为有关不断扩大的 MOUD 表述的覆盖范围和使用的政策和实践提供信息。