National Institute on Drug Abuse Clinical Trial Network: New England Consortium Node

国家药物滥用研究所临床试验网络：新英格兰联盟节点

• 批准号: 10684501
• 负责人: Gail D'Onofrio
• 金额: $ 442.87万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10684501
• 关键词: Accident and Emergency department; Ancillary Study; Buprenorphine; Case Series; Clinical; Clinical Trials Network; Competence; Development; Effectiveness; Electronic Health Record; Eligibility Determination; Emergency Department patient; Emergency department visit; Hour; Mental disorders; National Institute of Drug Abuse; New England; Opioid; Patients; Pharmaceutical Preparations; Phenotype; Procedures; Randomized Controlled Trials; Research; Resources; Signs and Symptoms; Site; Soft Tissue Infections; Training; Validation; Withdrawal; Withdrawal Symptom; addiction; chronic pain; compare effectiveness; cost effective; design; experience; implementation facilitation; opioid overdose; opioid use; opioid use disorder; opioid withdrawal; patient engagement; 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.

抽象的 本研究将 (1) 为大约 30 个急诊科 (ED) 站点招募、培训和提供资源 在美国各地使用实施促进策略为患者提供 ED 发起的 BUP 患有阿片类药物使用障碍 (OUD)，但未接受治疗阿片类药物使用障碍 (MOUD) 的药物。一次 充分实现后，站点将 (2) 进行随机对照试验 (RCT) 比较舌下含服丁丙诺啡 (SL-BUP) 与缓释丁丙诺啡的有效性 (XR-BUP) 评估 ED 患者在 ED 就诊 7 天后接受正式成瘾治疗的情况。此外，在 作为该研究的辅助部分，我们将 (3) 评估 XR-BUP 在使用临床阿片类药物的 ED 患者中的使用情况 病例系列中戒断量表 (COS) 评分 < 8 可能会扩大更大范围患者的资格 针对那些很少或没有阿片类药物戒断症状的患者进行随机对照试验。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，这两者都将为主要 RCT 提供信息。