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公共卫生危机，包括吸毒过量和其他毒品- 相关伤害。2020年，有超过10万人死于服药过量，其中一半以上是由人工合成的 阿片类药物，如芬太尼。尽管美国的阿片类药物危机引起了公共卫生的极大关注，但这些 危害继续增长，并对个人、家庭和社区产生巨大影响。在这些人中 应对阿片类药物危机的挑战是，随着药物供应的变化，阿片类药物危机继续演变， 可获得的治疗、受影响的人群以及公众的看法。关于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 迫切需要恢复，以便为公共卫生干预、治疗实施和新的 治疗的发展。该项目的总体目标是进行两个长期的后续行动 大型国家药物加成研究所(NIDA)临床试验网络(CTN)临床试验由 美国国立卫生研究院(NIH)帮助戒除成瘾长期(Hear)倡议开始填补这些 知识方面的重要差距。该方案侧重于第一阶段，即纵向跟踪研究，将 收集最初4年研究期间患有阿片类药物使用障碍(OUD)的成年人的年度结果数据。这 纵向的观察性研究将需要对感兴趣的领域(例如，物质)进行年度电话评估 使用、治疗参与度)以及通过短信和电子邮件分发的月度评估 由参与者以电子方式填写。这第一阶段的目的是描述大学的长期进程。 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中评估OUD长期病程和恢复情况的研究。在第二阶段，研究 旨在将数据收集扩大到更多感兴趣的人群，包括来自其他CTN研究的数据。