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: 10657719
• 负责人: KAVITA M BABU
• 金额: $ 69.23万
• 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/10657719
• 关键词: Accident and Emergency department; Acetylfentanyl; 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; carfentanil; clinical care; clinical practice; drug testing; evidence base; evidence based guidelines; expectation; experience; fentanyl use; 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.

摘要 芬太尼及其类似物（又名芬太尼）替代海洛因非法药物供应中的芬太尼）， 扰乱了院前、急诊科非致命性阿片类药物过量患者的医疗护理 (ED)和住院病人的情况。担心传统的纳洛酮给药可能对芬太尼不太有效， 迫使院前人员和艾德临床医生使用更高的纳洛酮给药方案， 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，作为掺杂物或伴随使用），并可能影响患者纳洛酮给药 需要和临床护理课程，如需要药物激动和住院。一个在- 深入了解芬太尼和伴随的多种物质暴露如何影响纳洛酮给药需求 临床护理课程将能够创建基于证据的指南，以优化临床护理。 在这个UG 3/UH 3项目Sentanyl II中，我们将对905名患者进行一项多州、多中心的观察性研究。 非致死性阿片类药物过量成人艾德患者。Sentanyl II基于我们对Sentanyl/R21 DA 046734的研究 在此期间，我们开发并试验了组件（例如，研究方案、数据收集工具 调查，发现测试），将在这个项目中使用，并获得了成功的经验， 完成这项大规模的研究。在Sentanyl II的UG 3阶段，我们首先将调整和扩展R21研究 获得关于成人接受的治疗和临床护理过程的更全面信息的方案 非致命性阿片类药物过量患者。我们还将纳入血液采样用于发现测试，沿着 调查参与者的药物使用和过量用药史，纳入Sentanyl II方案。接下来我们就 在两个马萨诸塞州大学（UMass）医学中心ED进行Sentanyl II的初步研究。我们将 根据我们在UG 3阶段的经验和观察结果，根据需要修订研究方案。在UH 3 在第一阶段，我们将继续在两个马萨诸塞大学ED Sentanyl II，并将该项目扩大到三个ED 在其所在地非致死性和致死性阿片类药物过量发生率较高的其他研究中心： 佛罗里达/杰克逊维尔、马里兰州/巴尔的摩大学和西弗吉尼亚大学。 Sentanyl II的产品将是：（1）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的非法物质和药物; 如何：（2）纳洛酮给药对临床期望的反应受芬太尼和其他阿片类药物的影响， 酒精和其他非法药物以及自我报告的阿片类药物过量和药物使用 病史;（3）临床病程受芬太尼和其他阿片类药物、酒精和其他非法药物的影响， 药物，以及自我报告的阿片类药物过量和药物使用史。所了解的情况 Sentanyl II可以帮助重新评估当前的临床实践，并帮助创建证据- 紧急护理指南。