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 本研究将（1）为约30个急诊科（艾德）研究中心招募、培训和提供资源 在整个美国，使用实施促进策略为患者提供ED启动的BUP 出现阿片类药物使用障碍（OUD），未接受阿片类药物使用障碍（MOUD）的药物治疗。一旦 充分实施后，研究中心将（2）进行随机对照试验（RCT）， 比较舌下丁丙诺啡（SL-BUP）与缓释丁丙诺啡的有效性 （XR-BUP）对艾德患者在艾德就诊后7天参与正式成瘾治疗的影响。另外在 作为研究的辅助部分，我们将（3）评估XR-BUP在临床阿片类药物治疗的艾德患者中的使用 在病例系列中，戒断量表（COS）评分< 8分，可能会扩大患者在较大的 RCT针对那些几乎没有阿片类药物戒断症状的患者。最后，我们将（4）开发和验证 艾德电子健康记录（HER）阿片类药物相关表型，这两项均将告知主要RCT。