Clinical Trials Network New England Consortium Node: Admin Supplement CTN0126

项目概要/摘要 美国继续面临药物过量和其他药物滥用等持续的公共卫生危机。 相关危害。 2020 年，有超过 10 万人因吸毒过量死亡，其中一半以上是由于合成药物所致 阿片类药物，例如芬太尼。尽管美国的阿片类药物危机引起了公共卫生部门的高度关注，但这些 危害继续增加，并对个人、家庭和社区产生巨大影响。其中 解决阿片类药物危机面临的挑战是，随着药物供应的变化，危机仍在不断演变， 可用的治疗、受影响的人群以及公众的看法。阿片类药物疗程的长期数据 使用障碍（OUD）、预后的个体差异、治疗的长期效果以及标志物 迫切需要恢复来为公共卫生干预措施、治疗实施和新方法提供信息 治疗的发展。该项目的总体目标是对两个 大型国家药物添加研究所 (NIDA) 临床试验网络 (CTN) 通过以下机构资助的临床试验 美国国立卫生研究院 (NIH) 帮助戒除成瘾长期 (HEAL) 计划开始填补这些空白 知识上的重大差距。该协议侧重于第一阶段，即纵向后续研究，将 收集阿片类药物使用障碍 (OUD) 成人初始 4 年研究期的年度结果数据。这个 纵向观察性研究将需要对感兴趣的领域（例如，物质 使用情况、治疗参与度）以及通过短信和电子邮件分发的每月评估 由参与者以电子方式完成。第一阶段旨在描述 OUD 的长期进程 并创建一个结果数据存储库，用于未来的概念开发和分析 CTN 内评估 OUD 长期病程和恢复的研究。第二阶段，研究 旨在将数据收集范围扩大到更多感兴趣的人群，包括其他 CTN 研究的数据收集。

Project Summary/Abstract The United States continues to be faced with an ongoing public health crisis of drug overdose and other drug- related harms. In 2020 there were more than 100,000 overdose deaths, with more than half due to synthetic opioids such as fentanyl. Despite significant public health attention toward the opioid crisis in the US, these harms continue to grow and to have tremendous impacts on individuals, families and communities. Among the challenges in addressing the opioid crisis is that it continues to evolve, with changes in the drug supply, available treatment, the populations affected, and public perceptions. Long-term data on the course of opioid use disorder (OUD), individual differences in prognosis, the long-term effects of treatment, and markers of recovery are urgently needed to inform public health interventions, treatment implementation, and novel treatment development. The overarching objective of this project is to conduct a long-term follow-up of two large National Institutes on Drug Addition (NIDA) Clinical Trial Network (CTN) clinical trials funded through the National Institutes of Health (NIH) Helping End Addiction Long-term (HEAL) Initiative to begin to fill these important gaps in knowledge. This protocol focuses on the first stage, a longitudinal follow-up study that will collect yearly outcomes data for an initial 4-year study period on adults with opioid use disorder (OUD). This longitudinal, observational study will entail annual phone assessments of domains of interest (e.g., substance use, treatment engagement) as well as monthly assessments that are distributed via SMS and email to be completed electronically by the participant. This first stage aims to characterize the long-term course of OUD and to create a repository of outcomes data that will be used for future concept development and analysis of studies within the CTN that evaluate the long-term course and recovery of OUD. In the second stage, the study aims to expand data collection to additional populations of interest, including from other CTN studies.