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

项目总结 涉及芬太尼的阿片使用障碍(OUD)是一个主要的公共卫生问题。OUD处理使用 丁丙诺啡可降低全因死亡率和药物相关发病率，并可通过许可开始使用 任何门诊或住院环境中的处方医生。对于使用芬太尼的个人来说，开始的过程 丁丙诺啡因急促戒断而变得越来越复杂。在启动期间撤回 丁丙诺啡阻止一些人开始治疗，并与治疗下降有关- 并在那些真正开始的人中故态复萌。这个项目的目标是测试初步的疗效，安全性， 一种启动丁丙诺啡治疗OUD的新方法的可行性和接受性 在门诊环境中，不需要或催促阿片类药物戒断。我们将招募60名受试者 宾夕法尼亚大学研究中心的未经治疗的OUD和最近的芬太尼使用 上瘾了。受试者将被随机分配到两个手臂中的一个：标准入门，受试者将在其中开始 丁丙诺啡在临床阿片类药物中度戒断后8小时戒断 戒断规模(奶牛)至少11头；或一种新的低剂量(“微剂量”)方法，其开始于 奶牛4和丁丙诺啡剂量在10小时内递增，而不是持续使用全激动剂 阿片类药物。我们将比较每种方法的成功率，并将其定义为达到每日总成功率 8毫克丁丙诺啡不增加-gt；6的奶牛基线和未提前终止的剂量 无论出于什么原因。这项研究的结果将被用来支持R01应用程序来测试这种新方法 在真实世界的门诊环境中启动丁丙诺啡，并对未经治疗的患者进行更大样本的调查 奥德。这一方法在增加以办公室为基础的治疗方面有广泛的应用。

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.