Sentanyl II: A Multi-State Analysis of Fentanyl/Analogs, Naloxone, and Clinical Features of Non-Fatal Opioid Overdose

Sentanyl II：芬太尼/类似物、纳洛酮的多状态分析以及非致命阿片类药物过量的临床特征

• 批准号: 10525268
• 负责人: KAVITA M BABU
• 金额: $ 73.74万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10525268
• 关键词: Accident and Emergency department; Admission activity; Adult; Affect; Agitation; Alcohols; Area; Baltimore; Benzodiazepines; Blood; Blood Tests; Blood specimen; Caring; Clinical; Clinical Management; Cocaine; Communities; Data; Data Collection; Documentation; Dose; Drug usage; Education; Emergency Care; Emergency Department patient; Ethanol; Evaluation; Exposure to; Fentanyl; Florida; Forensic Sciences; Guidelines; Heroin; Hospital Personnel; Hospitals; Illicit Drugs; Incidence; Inpatients; Intramuscular; Intravenous; Intubation; Knowledge; Length of Stay; Locales; Maryland; Massachusetts; Measures; Medical; Medical center; Methamphetamine; Naloxone; Observational Study; Opioid; Overdose; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Pilot Projects; Prevalence; Protocols documentation; Recording of previous events; Recurrence; Regimen; Research; Respiratory Failure; Resuscitation; Sample Size; Sampling; Sedation procedure; Site; Stimulant; Surveys; Test Result; Testing; United States; Universities; Urine; West Virginia; analog; base; carfentanil; clinical care; clinical practice; drug testing; evidence base; evidence based guidelines; expectation; experience; hypnotic; improved; instrument; mortality; opioid overdose; pilot test; recruit; respiratory; response; sedative; study population; substance use

Abstract The replacement of heroin by fentanyl and its analogs (a.k.a. fentanyls) in the illicit drug supply has disrupted the medical care of non-fatal opioid overdose patients in the pre-hospital, emergency department (ED) and inpatient settings. Concerns that traditional naloxone dosing may be less effective for fentanyls have compelled pre-hospital personnel and ED clinicians to use higher naloxone dosing regimens that are without evidence-based support. In addition, use of fentanyls with other substances in the community is now common (intentionally or unintentionally, as adulterants or concomitant use), and may affect patient naloxone dosing needs and clinical care courses, such as need for medications for agitation and inpatient admission. An in- depth understanding of how fentanyls and concomitant polysubstance exposures affect naloxone dosing needs and clinical care courses would enable the creation of evidence-based guidelines to optimize clinical care. In this UG3/UH3 project, Sentanyl II, we will conduct a multi-state, multi-site, observational study of 905 non-fatal opioid overdose adult ED patients. Sentanyl II is based on our research from Sentanyl/R21DA046734 during which we developed and pilot tested the components (e.g., study protocol, data collection instruments, surveys, discovery testing) that will be employed in this project, and gained the experience to successfully complete this larger scale study. In the UG3 phase on Sentanyl II, we first will adapt and expand the R21 study protocol to obtain more comprehensive information on the treatment received and clinical care course of adult non-fatal opioid overdose patients. We will also incorporate blood sampling for discovery testing along with surveys of participants about their drug use and overdose history into the Sentanyl II protocol. Next, we will conduct a pilot study of Sentanyl II at two University of Massachusetts (UMass) Medical Center EDs. We will revise the study protocol as needed based on our experience and observations in the UG3 phase. In the UH3 phase, we will continue Sentanyl II in the two UMass EDs and expand the project to seven more EDs at three additional study sites with high incidence of non-fatal and fatal opioid overdoses in their locales: University of Florida/Jacksonville, University of Maryland/Baltimore, and West Virginia University. The products of Sentanyl II will be: (1) estimates of the prevalence of fentanyls and other opioids, alcohol, and other illicit and pharmaceutical substances contributing to non-fatal overdoses; and an understanding of how: (2) naloxone administration to the clinically desired response is affected by fentanyls and other opioids, alcohol, and other illicit and pharmaceutical substances, as well as self-reported opioid overdose and drug use history; (3) clinical course is affected by fentanyls and other opioids, alcohol, and other illicit and pharmaceutical substances, as well as self-reported opioid overdose and drug use history. Knowledge obtained from Sentanyl II can assist in the re-evaluation of current clinical practice and aid in the creation of evidence- based guidelines for emergency care.

抽象的 非法药物供应中的海洛因被芬太尼及其类似物（又名芬太尼）替代 扰乱了院前、急诊室非致命阿片类药物过量患者的医疗护理 (ED) 和住院环境。人们担心传统的纳洛酮剂量可能对芬太尼效果较差 迫使院前急救人员和急诊室临床医生使用更高的纳洛酮剂量方案，而这些方案没有 基于证据的支持。此外，芬太尼与其他物质在社区中的使用现在很常见 （有意或无意，作为掺杂物或同时使用），并可能影响患者纳洛酮的剂量 需求和临床护理课程，例如需要药物治疗躁动和住院。一个在- 深入了解芬太尼和伴随的多物质暴露如何影响纳洛酮剂量需求 临床护理课程将有助于创建基于证据的指南，以优化临床护理。 在这个 UG3/UH3 项目 Sentanyl II 中，我们将对 905 非致命性阿片类药物过量成年 ED 患者。 Sentanyl II 基于我们对 Sentanyl/R21DA046734 的研究 在此期间，我们开发并试点测试了组件（例如，研究方案、数据收集仪器、 调查、发现测试）将在该项目中使用，并获得了成功的经验 完成这项更大规模的研究。在Sentanyl II的UG3阶段，我们首先将调整和扩展R21研究 协议以获得有关成人接受的治疗和临床护理过程的更全面的信息 非致命阿片类药物过量患者。我们还将纳入血液采样以进行发现测试 对参与者进行 Sentanyl II 方案的药物使用和过量用药史调查。接下来，我们将 在马萨诸塞大学 (UMass) 医学中心的两个急诊室进行 Sentanyl II 的试点研究。我们将 根据我们在 UG3 阶段的经验和观察，根据需要修改研究方案。在UH3中 阶段，我们将在两个麻省大学 ED 中继续 Sentanyl II，并将该项目扩展到三个 ED 中的另外 7 个 ED。 当地非致命和致命阿片类药物过量发生率高的其他研究地点： 大学 佛罗里达大学/杰克逊维尔分校、马里兰大学/巴尔的摩分校和西弗吉尼亚大学。 Sentanyl II 的产品将是：(1) 对芬太尼和其他阿片类药物、酒精、 以及其他导致非致命性过量服用的非法药物和药物；以及对 如何：(2) 纳洛酮给药达到临床所需反应会受到芬太尼和其他阿片类药物的影响， 酒精和其他非法药物和药物，以及自我报告的阿片类药物过量和药物使用 历史; (3) 临床病程受芬太尼和其他阿片类药物、酒精和其他违禁药物的影响 药物物质，以及自我报告的阿片类药物过量和药物使用史。获得的知识 Sentanyl II 可以协助重新评估当前的临床实践并帮助创建证据- 为基础的紧急护理指南。