Safety and Efficacy of High Dose Buprenorphine Induction in Fentanyl Positive Emergency Department Patients

高剂量丁丙诺啡诱导治疗芬太尼阳性急诊科患者的安全性和有效性

基本信息

批准号：
10525271
负责人：
Ethan Adrian Cowan
金额：
$ 67.87万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10525271
关键词：
Abstinence Accident and Emergency department American Benzodiazepines Buprenorphine Case Series Case Study Client satisfaction Clinical effectiveness Data Dose Emergency Care Emergency Department patient Emergency Medicine Enrollment Event Fentanyl Guidelines Healthcare Systems Hour Illicit Drugs Individual Lead Medicine Methadone Methods Morbidity - disease rate Opiate Addiction Opioid Outcome Outpatients Overdose Patients Persons Pharmaceutical Preparations Phase Polypharmacy Population Protocols documentation Provider Randomized Randomized Controlled Trials Reporting Resources Risk Safety Site Societies Stimulant Therapeutic Time United States Substance Abuse and Mental Health Services Administration Withdrawal addiction arm base clinical efficacy cohort college craving efficacy outcomes health care availability implementation outcomes meetings mortality opioid agonist therapy opioid mortality opioid overdose opioid use disorder overdose death patient oriented patient population patient stratification programs prospective test synthetic opioid uptake

项目摘要

Summary This UG3/UH3 is based on the need to identify optimal induction strategies for buprenorphine (BUP) in patients’ with untreated opioid use disorder (OUD). Prior BUP induction studies and guidelines including those from the Substance Abuse and Mental Health Services Administration, the American Society of Addiction Medicine and the American College of Emergency Medicine differ with regard to BUP dosing for treatment induction. Furthermore, existing guidelines were developed before the proliferation of fentanyl in the illicit drug supply. Recently, reports have raised concerns that patients with OUD using fentanyl have more difficulty with BUP induction with more worsening/precipitated withdrawal events. These concerns have led to a proliferation of BUP induction strategies that range from low–and-slow “micro-dosing” to rapid “supra-therapeutic” BUP dosing. This proposal aims to determine whether standard buprenorphine induction results in more worsening/precipitated withdrawal events in fentanyls-positive users than other opioid-dependent patients and to examine the safety, tolerability, acceptability and clinical effectiveness of a single high dose BUP induction strategy in Emergency Department (ED) patients with untreated OUD. UG3 specific aims. Aim 1a. First we will develop and manualized escalating high dose BUP induction protocols that can be delivered with high fidelity in the ED. 1b. Then we will evaluate the safety and tolerability of escalating initial BUP dose in three 10-person cohorts (16mg, 24mg, 32mg) of fentanyl positive ED patients with untreated OUD meeting criteria for ED initiated BUP. 1c. We will collect data on patient centered and operational outcomes including patient satisfaction, need for rescue BUP doses and ancillary medications. Aim 2. Perform a pilot multicenter RCT of high versus standard BUP induction at four sites with well-established ED BUP initiation programs to prove feasibility and validate patient satisfaction. 2a. Compare the optimal high dose induction strategy from Aim 1 to a “standard” ED induction strategy in 80 (20 per site) fentanyl positive ED patients meeting criteria for ED initiated BUP randomized 1:1. 2b. Assess the primary composite outcome of precipitated/worsening withdrawal in each study arm. 2c. Compare secondary patient centered and operational outcomes in each study arm. UH3 specific aims. Aim 1a. In a multicenter RCT performed at the four UG3 sites, compare high versus standard dose BUP induction randomized 1:1 on the primary composite outcome of worsening/precipitated withdrawal in 708 patients. Aim 2a. Compare high-dose BUP induction to standard BUP induction on the clinical efficacy outcome of engagement in comprehensive addiction treatment at 7-days post BUP induction. 2b. Compare patient centered and implementation outcomes between study arms.

概括此UG3/UH3是基于确定丁丙诺啡（BUP）的最佳指示策略的需求患有未经治疗的阿片类药物使用障碍（OUD）的患者。来自美国加法学会的药物滥用和精神卫生服务管理医学和美国急诊医学学院在bup剂量方面有所不同此外，在非法药物中芬太尼的繁殖之前，还制定了Exsting指南 Suppry。 bup诱导越来越恶化/沉淀的戒断事件。 bup指示策略的范围从“微量剂量”到快速“超级治疗” bup 剂量。与其他依赖阿片类药物的患者相比检查单个高剂量BUP指示的安全性，耐受性，可接受和临床有效的有效有效效率急诊科（ED）未经治疗的OUD患者的策略。 UG3特定目标。可以在ED中使用高保真的协议。芬太尼阳性ED患者的三个10人群（16mg，24mg，32mg）的初始BUP剂量上升未经治疗的OUD符合ED的标准，我们将收集有关患者的数据运作结果，包括患者满意度，需要救援bup剂量和辅助药物 2。在四个位置上执行高级与标准bup指示的飞行员多中心RCT，并建立了良好的ED bup启动计划可见和验证患者的满意度。从AIM 1到80（每个位置20）芬太尼阳性的“标准”指示策略的剂量诱导策略 ED患者符合ED的标准，启动BUP随机分配了1：1.2B。每个研究部门的沉淀/恶化戒断。每个研究部门的操作结果。 UH3特定目标。标准剂量BUP指示随机1：1在恶化/沉淀的主要复合结果上在708例AIM 2A中提取。在BUP指示后7天参与综合添加治疗的临床疗效。 2B。