Clinical Trials Network New England Consortium Node: Admin Supplement CTN0126

临床试验网络新英格兰联盟节点：管理补充 CTN0126

• 批准号: 10655828
• 负责人: Gail D'Onofrio
• 金额: $ 68.83万
• 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: 2022-07-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10655828
• 关键词: Address; Adult; Affect; Attention; Clinical; Clinical Trials; Clinical Trials Network; Communities; Data; Data Collection; Development; Electronic Mail; Family; Fentanyl; Follow-Up Studies; Funding; Future; Helping to End Addiction Long-term; Illness impact; Individual; Individual Differences; Institutes; Knowledge; Long-Term Effects; Longitudinal observational study; Longterm Follow-up; New England; Outcome; Overdose; Participant; Perception; Pharmaceutical Preparations; Population; Prevention approach; Process; Prognosis; Protocols documentation; Public Health; Recovery; Telephone; United States; United States National Institutes of Health; improved; interest; novel; opioid epidemic; opioid use disorder; overdose death; public health intervention; repository; substance use treatment; synthetic opioid; therapy development; treatment effect

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.

项目摘要/摘要 美国继续面临着持续的药物过量和其他药物的公共卫生危机 相关危害。在2020年，有超过100,000人过量死亡，归因于合成的一半以上 阿片类药物，例如芬太尼。尽管公众对美国阿片类药物危机的关注很大，但 危害继续增长，并对个人，家庭和社区产生巨大影响。在 解决阿片类药物危机的挑战是，随着药物供应的变化，它继续发展 可用的治疗，受影响的人群和公众看法。阿片类药物过程的长期数据 使用障碍（OUD），预后的个体差异，治疗的长期影响以及 迫切需要恢复以告知公共卫生干预措施，治疗实施和新颖 治疗开发。该项目的总体目的是进行两次的长期随访 大型国立药物添加研究（NIDA）临床试验网络（CTN）临床试验通过 国立卫生研究院（NIH）帮助结束成瘾长期（治愈）倡议以开始填补这些倡议 知识的重要差距。该协议重点是第一阶段，这是一项纵向后续研究 收集有关阿片类药物使用障碍成人（OUD）的最初为期4年研究期的年度结果数据。这 纵向，观察性研究将需要对感兴趣领域的年度电话评估（例如，物质 使用，治疗参与）以及通过SMS和电子邮件进行分发的每月评估 由参与者以电子方式完成。第一阶段旨在表征Oud的长期过程 并创建一个结果数据存储库，该数据将用于未来的概念开发和分析 CTN中评估OUD的长期课程和恢复的研究。在第二阶段，研究 旨在将数据收集扩展到其他感兴趣的人群，包括其他CTN研究。