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

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.

项目概要涉及芬太尼的阿片类药物使用障碍 (OUD) 是 OUD 治疗的一个主要公共卫生问题。丁丙诺啡可降低全因死亡率和药物相关发病率，并且可以通过获得许可开始使用任何门诊或住院环境中的处方者对于使用芬太尼的个人，开始的过程。丁丙诺啡因开始戒断期间突然戒断而变得越来越复杂。丁丙诺啡会阻止某些人开始治疗，并与治疗下降有关该项目的目标是测试初步疗效、安全性、启动丁丙诺啡治疗 OUD 的新方法的可行性和可接受性在门诊环境中，无需或促使阿片类药物戒断，我们将招募 60 名受试者。宾夕法尼亚大学研究中心发现未经处理的 OUD 和最近使用的芬太尼受试者将被随机分配到两个组之一：标准启动，其中受试者将开始。一旦他们使用临床阿片剂出现中度阿片类药物戒断，在戒断 >8 小时后使用丁丙诺啡戒断量表 (COWS) 至少 11；或采用新的低剂量（“微剂量”）方法，从以下开始： COWS<4，并且丁丙诺啡剂量在 10 小时内逐步增加，但没有持续使用全激动剂我们将比较每种方法的成功率，“成功”定义为达到每日总量。 8 mg 丁丙诺啡剂量，COWS 较基线没有增加 >6，且没有提前终止无论出于何种原因，本研究的结果将用于支持 R01 应用程序来测试这种新颖的方法。在现实世界的门诊环境中，对未经治疗的个体进行较大样本的启动丁丙诺啡治疗 OUD。这种方法在增加 OUD 办公室治疗的机会方面具有广泛的应用。