Rapid outpatient low-dose initiation of buprenorphine for individuals with OUD using fentanyl

使用芬太尼对 OUD 患者进行快速门诊低剂量丁丙诺啡起始治疗

基本信息

批准号：
10738961
负责人：
KYLE Matthew KAMPMAN
金额：
$ 23.28万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-15 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10738961
关键词：
Absence of pain sensation Abstinence Adherence Affinity Aftercare Buprenorphine Case Series Case Study Chronic Clinical Clinical Trials Dose Dropout Drug Kinetics Fentanyl Goals Heroin Hospitalization Hospitals Hour Hydromorphone Illicit Drugs Individual Inpatients Licensing Maintenance Measures Methodology Monitor Morbidity - disease rate Norfentanyl North America Opioid Receptor Binding Opioid agonist Outpatients Overdose Participant Patients Pennsylvania Persons Pharmaceutical Preparations Pilot Projects Plasma Process Protocols documentation Public Health Randomized Randomized, Controlled Trials Regulation Relapse Research Retrospective cohort study Risk Safety Sampling Speed Surveys Testing Therapeutic Time Universities Urine Withdrawal Work addiction arm buprenorphine treatment design efficacy testing experience fentanyl use improved innovation interest lipophilicity mortality mu opioid receptors novel novel strategies opioid use opioid use disorder opioid withdrawal overdose risk pilot trial prevent primary care setting primary outcome public health priorities recruit safety study safety testing secondary outcome success synthetic opioid

Absence of pain sensation Abstinence Adherence Affinity Aftercare Buprenorphine Case Series Case Study Chronic Clinical Clinical Trials Dose Dropout Drug Kinetics Fentanyl Goals Heroin Hospitalization Hospitals Hour Hydromorphone Illicit Drugs Individual Inpatients Licensing Maintenance Measures Methodology Monitor Morbidity - disease rate Norfentanyl North America Opioid Receptor Binding Opioid agonist Outpatients Overdose Participant Patients Pennsylvania Persons Pharmaceutical Preparations Pilot Projects Plasma Process Protocols documentation Public Health Randomized Randomized, Controlled Trials Regulation Relapse Research Retrospective cohort study Risk Safety Sampling Speed Surveys Testing Therapeutic Time Universities Urine Withdrawal Work addiction arm buprenorphine treatment design efficacy testing experience fentanyl use improved innovation interest lipophilicity mortality mu opioid receptors novel novel strategies opioid use opioid use disorder opioid withdrawal overdose risk pilot trial prevent primary care setting primary outcome public health priorities recruit safety study safety testing secondary outcome success synthetic opioid

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项目摘要

PROJECT SUMMARY Opioid use disorder (OUD) involving fentanyl is a major public health problem. OUD treatment with buprenorphine reduces all-cause mortality and drug-related morbidity and can be started by licensed prescribers in any outpatient or inpatient setting. For individuals using fentanyl, the process of starting buprenorphine is increasingly complicated by precipitated withdrawal. Withdrawal during initiation of buprenorphine deters some individuals from starting treatment and has been associated with treatment drop- out and relapse among those who do start. The goal of this project is to test the preliminary efficacy, safety, feasibility, and acceptability of a novel approach to initiating buprenorphine treatment for OUD that can be used in outpatient setting without requiring or precipitating opioid withdrawal. We will recruit 60 subjects with untreated OUD and recent fentanyl use through the University of Pennsylvania's Center for the Studies of Addiction. Subjects will be randomized to one of two arms: standard initiation, in which subjects will start buprenorphine after >8 hours of abstinence once they develop moderate opioid withdrawal with Clinical Opiate Withdrawal Scale (COWS) at least 11; or a novel low-dose (“micro-dose”) approach, which is started with COWS<4 and where buprenorphine doses are escalated over 10 hours, without ongoing use of full-agonist opioids. We will compare success rates with each approach, with “success” defined as reaching a total-daily dose of 8 mg buprenorphine without an increase of >6 in COWS from baseline and without early termination for any reason. Findings from this study will be used to support an R01 application to test this novel approach to initiating buprenorphine in real-world, outpatient settings with a larger sample of individuals with untreated OUD. This methodology has broad applications for increasing access to office-based treatment for OUD.

项目摘要涉及芬太尼的阿片类药物使用障碍（OUD）是一个主要的公共卫生问题。 Oud治疗丁丙诺啡降低了全因死亡率和与药物有关的发病率，可以通过许可开始在任何门诊或住院设置中的处方者。对于使用芬太尼的个体，开始的过程丁丙诺啡越来越复杂。启动期间退出丁丙诺啡确定某些人的开始治疗，并且与治疗降低有关在那些开始的人中传递并继电器。该项目的目的是测试初步效率，安全性，可行性和一种新型方法的可接受性来启动可以使用的OUD丁丙诺啡治疗在门诊环境中，无需或促进阿片类药物戒断。我们将招募60个主题未经治疗的OUD和最近通过宾夕法尼亚大学研究中心的芬太尼使用瘾。受试者将被随机分为两个臂之一：标准启动，其中受试者将开始丁丙诺啡一旦通过临床蛋白石出现中等阿片类药物的戒酒后，丁丙诺啡一旦戒酒> 8小时提取量表（牛）至少11个；或一种新型的低剂量（“微剂量”）方法牛<4，丁丙诺啡剂量在10个小时内升级，而无需持续使用全动阿片类药物。我们将将成功率与每种方法进行比较，而“成功”定义为达到每日总计剂量为8毫克丁丙诺啡，从基线且没有提早终止的母牛的增加> 6 出于任何原因。这项研究的发现将用于支持R01应用程序来测试这种新方法为了在现实世界中启动丁丙诺啡，门诊设置具有较大的未经处理的个体样本 Oud。该方法有广泛的应用程序可以增加对OUD获得基于办公室的治疗的访问。