The National Drug Abuse Clinical Trials Network: New England Consortium Node

国家药物滥用临床试验网络：新英格兰联盟节点

• 批准号: 10450554
• 负责人: Gail D'Onofrio
• 金额: $ 170万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10450554
• 关键词: Accident and Emergency department; Buprenorphine; Case Series; Clinical; Clinical Trials Network; Drug abuse; Electronic Health Record; Eligibility Determination; Emergency Department patient; Emergency department visit; New England; Opioid; Patients; Phenotype; Randomized Controlled Trials; Resources; Site; Training; Withdrawal Symptom; addiction; compare effectiveness; design; implementation facilitation; opioid use disorder; opioid withdrawal; patient engagement; prescription opioid; primary outcome; recruit

ABSTRACT This study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated BUP for patients presenting with opioid use disorder (OUD) not receiving medications for opioid use disorder (MOUD). Once implementation is adequately achieved, the sites will (2) conduct a randomized controlled trial (RCT) to compare the effectiveness of sublingual buprenorphine (SL-BUP) versus extended-release buprenorphine (XR-BUP) on ED patients’ engagement in formal addiction treatment 7-days after their ED visit. In addition, in an ancillary component of the study, we will (3) assess the use of XR-BUP in ED patients with Clinical Opioid Withdrawal Scale (COS) scores < 8 in a case series to potentially expand the eligibility of patients in the larger RCT to those presenting with little to no opioid withdrawal symptoms. Finally, we will (4) develop and validate ED electronic health record (HER) opioid-related phenotypes, both of which will inform the main RCT.

摘要 这项研究将(1)招聘、培训和向大约30个急诊部(ED)站点提供资源 在美国各地使用实施促进战略为患者提供ED发起的BUP 出现阿片使用障碍(OUD)，没有接受阿片使用障碍的药物治疗(Moud)。一次 如果实施得到充分实现，这些站点将(2)进行随机对照试验(RCT)以 丁丙诺啡舌下含服与丁丙诺啡缓释片的疗效比较 (XR-BUP)关于勃起功能障碍患者就诊后7天参与正式成瘾治疗的情况。此外，在 作为这项研究的辅助组成部分，我们将(3)评估XR-BUP在患有临床阿片类药物的ED患者中的使用 戒断量表(COS)在病例系列中的得分&lt；8，以潜在地扩大较大规模患者的资格 RCT适用于那些出现很少或没有阿片类药物戒断症状的人。最后，我们将(4)开发和验证 ED电子健康记录(HER)与阿片类药物相关的表型，这两种表型都将告知主要的随机对照试验。