NorthStar Node of the Clinical Trials Network

这项研究是NIH帮助结束成瘾长期(Hear)倡议的一部分，该倡议旨在加快科学解决国家阿片类药物公共健康危机的速度。NIH Hear Initiative支持整个NIH的研究，以改善阿片类药物滥用和成瘾的治疗。自2015年加入NIDA全国药物滥用治疗临床试验网络(CTN)以来，北极星节点为CTN的目标和优先事项做出了重大贡献。北极星节点及其调查人员领导或共同领导了五项CTN协议，作为七项CTN研究的研究站点，共同 担任CTN指导委员会和数据科学工作组主席，在研究发展委员会任职，并为几个特殊兴趣小组做出贡献。北极星节点的研究组合包括传统随机对照试验(CTN-0068)、实用比较有效性研究(CTN-0098A和CTN-0099)、实施科学(CTN-0074、CTN-0098B和CTN-0099)、 社区参与性研究(CTN-0096)、数据科学(CTN-0076和CTN-0087)和保健服务研究(CTN-0070)。在此应用程序中，北极星节点有七个指导目标(北极星)：1)生成为政策和临床指南提供信息的证据；2)评估解决同时发生的SUD以及医疗和精神疾病的模型；3)使用学习健康的原则 这些研究包括：4)利用人工智能和其他数据科学方法加强对SUD的研究和护理；5)接触未被充分研究的人群，以确保SUD研究适用于不同的人群；6)利用实施科学来测试循证的SUD实践在普通医疗环境中的整合情况；7)测试SUD治疗的创新策略。实现这些目标的潜在研究包括1)甲基苯丙胺使用障碍的新治疗干预；2)在电子健康记录中开发机器学习算法，以针对物质使用障碍进行筛查并提高药物使用障碍的诊断能力；3)使用人群进行精确/个性化的药物研究 药代动力学，以更好地定义和改进药物剂量策略，以改善治疗结果；以及4)测试协作护理模式，以解决专业成瘾治疗环境中共存的慢性医疗疾病。我们的专业知识涵盖多个地点的临床试验、实施科学、基于社区的参与性研究、基于电子病历的干预、机器学习和自然语言处理，以及健康服务研究。除了社区合作伙伴，包括城乡综合卫生系统、为代表不足的少数族裔提供服务的联邦合格卫生中心、专门的成瘾治疗计划以及儿科和青少年健康诊所，北极星节点还带来了附属研究和 传播网络进入CTN，包括CTSA、SIREN、PCORnet、JCOIN、HOPE、成瘾技术转移中心网络协调办公室、一个学习健康系统培训方案(K12)、三个NIDA培训方案(T32)以及成瘾药物和成瘾精神病学研究金方案。北极星节点处于有利地位，可以解决当前和新出现的SUD问题，并推动该领域的研究，以改善患者结局并改变卫生系统。

This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to improve treatment for opioid misuse and addiction. Since joining the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) in 2015, the NorthStar Node has made significant contributions to the objectives and priorities of the CTN. The NorthStar Node and its investigators have led or co-led five CTN protocols, served as a research site for seven CTN studies, co- chaired the CTN Steering Committee and the Data Science Work Group, served on the Research Development Committee, and contributed to several special interest groups. The NorthStar Node's research portfolio includes traditional randomized controlled trials (CTN-0068), pragmatic comparative effectiveness research (CTN-0098A and CTN-0099), implementation science (CTN-0074, CTN-0098B, and CTN-0099), community-based participatory research (CTN-0096), data science (CTN-0076 and CTN-0087), and health services research (CTN-0070). In this application, the NorthStar Node has seven guiding objectives (POLARIS): 1) generating evidence that informs Policy and clinical guidelines; 2) evaluating models addressing co-Occurring SUD and medical and psychiatric conditions; 3) using principals of a Learning health system to conduct pragmatic trials; 4) using Artificial intelligence and other data sciences approaches to enhance SUD research and care; 5) Reaching understudied populations to ensure SUD research is relevant to diverse populations; 6) using Implementation science to test the integration of evidence-based SUD practices into general medical settings; and 7) testing innovative Strategies for SUD treatment. Potential studies to meet these objectives include 1) a novel therapeutic intervention for methamphetamine use disorder; 2) development of machine learning algorithms in the electronic health record to target substance use screening and enhance substance use disorder diagnoses; 3) precision/personalized medicine studies using population pharmacokinetics to better define and refine medication dosing strategies that improve treatment outcome; and 4) testing collaborative care models to address co-occurring chronic medical illnesses in specialty addiction treatment settings. Our expertise spans multi-site clinical trials, implementation science, community-based participatory research, EHR-based interventions, machine learning and natural language processing, and health services research. In addition to community partners that include urban and rural integrated health systems, federally qualified health centers serving underrepresented minorities, specialty addiction treatment programs, and pediatric and adolescent health clinics, the NorthStar Node brings affiliated research and dissemination networks into the CTN, including CTSA, SIREN, PCORNet, JCOIN, HOPE, the Network Coordinating Office of the Addiction Technology Transfer Centers, a learning health system training program (K12), three NIDA training programs (T32), and fellowship programs in addiction medicine and addiction psychiatry. The NorthStar Node is well situated to address current and emerging SUD issues and advance research in the field in order to improve patient outcome and transform health systems.