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

• 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
• 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

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， 丁丙诺啡可降低全因死亡率和药物相关发病率， 在任何门诊或住院环境中的处方者。对于使用芬太尼的个人来说， 丁丙诺啡因突然停药而变得越来越复杂。启动期间退出 丁丙诺啡阻止一些人开始治疗，并与治疗下降有关- 在那些已经开始的人中退出和复发。本项目的目的是测试初步的有效性，安全性， 可行性和可接受性的一种新的方法，开始丁丙诺啡治疗OUD， 不需要或促使阿片类药物戒断。我们将招募60名受试者， 未经治疗的OUD和最近的芬太尼使用通过宾夕法尼亚大学的研究中心， 成瘾受试者将被随机分配至两组之一：标准启动，受试者将开始 一旦使用临床阿片类药物出现中度阿片类药物戒断，则在禁欲> 8小时后使用丁丙诺啡 戒断量表（COWS）至少11;或一种新的低剂量（"微剂量"）方法， COWS <4且丁丙诺啡剂量在10小时内递增，未持续使用完全激动剂 阿片类药物我们将比较每种方法的成功率，"成功"定义为达到每日总 8mg丁丙诺啡剂量，COWS从基线增加> 6，且未提前终止 任何原因这项研究的结果将用于支持R01应用程序，以测试这种新方法 在现实世界中开始丁丙诺啡，门诊设置有较大样本的未经治疗的个体 OUD。这种方法具有广泛的应用，以增加获得办公室为基础的治疗OUD。