Clinical Core

临床核心

• 批准号: 10449222
• 负责人: HENRY RICHARD KRANZLER
• 金额: $ 60.69万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10449222
• 关键词: Acute; Adverse event; Advertising; Cancer Grant Supplements (P30); Caring; Clinical; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Services; Clinical Trials; Collection; Communication; Communities; Complement; Connecticut; Consultations; Data; Data Analyses; Data Collection; Data Reporting; Data Set; Development; Electronic Mail; Eligibility Determination; Ensure; Evaluation; Functional disorder; Funding; Generations; Image; Infrastructure; Institution; Institutional Review Boards; Intake; Investigational Drugs; Investigational New Drug Application; Joints; Ligands; Manuals; Measures; Methods; Monitor; National Institute of Drug Abuse; Neurosciences Research; Online Systems; Pain management; Participant; Patient Recruitments; Patients; Pennsylvania; Persons; Pharmaceutical Preparations; Philadelphia; Pilot Projects; Policies; Positron-Emission Tomography; Preparation; Procedures; Protocols documentation; Reporting; Research; Research Personnel; Resources; Risk; Sampling; Scanning; Schedule; Services; Site; Telephone; Testing; Tracer; United States Food and Drug Administration; United States National Institutes of Health; Universities; Visit; addiction; central database; cost; data management; data repository; data sharing; delta opioid receptor; efficacious treatment; imaging facilities; insight; medical schools; meetings; member; mental health center; neuroimaging; opioid exposure; opioid use; opioid use disorder; opioid withdrawal; outreach; participant retention; programs; recruit; research clinical testing; research facility; screening; symposium; treatment program

CLINICAL CORE The Penn PET Addiction Center of Excellence (PACE) will provide the infrastructure and resources needed to promote PET neuroimaging studies by investigators currently conducting funded clinical addiction research at the Penn and Yale Schools of Medicine. The Clinical Core will provide the clinical services required to conduct planned pilot projects and subsequent projects identified beginning in year two of the P30 grant period. The Clinical Core will leverage existing clinical research resources at the Center for Studies of Addiction, a well- established center at the PSOM, other clinical resources in Philadelphia, and those in New Haven, CT. The Clinical Core will provide specialized expertise in the recruitment and assessment of patients with opioid use disorder (OUD) and healthy control subjects (HCs). To recruit participants with OUD, the Clinical Core will collaborate with two nearby residential addiction treatment programs, the Kirkbride Center and Snyder House, in which patients are detoxified and maintained drug free for up to three months. These programs are near the Penn campus in Philadelphia, which ensures that patients can easily be transported to the PET facilities for imaging. The Clinical Neuroscience Research Unit at the Connecticut Mental Health Center will serve a similar purpose for OUD patients at Yale. The Clinical Core will also recruit, screen, and evaluate a sample of opioid- exposed HCs who will be matched to the OUD subjects on key variables. Using a core battery of assessments, to which project-specific assessments and procedures will be added, the Clinical Core will promote the joint analysis of findings across the pilot projects and enable investigators to compare HCs who undergo imaging using more than one PET ligand. The Clinical Core will also manage the clinical data and their integration with those obtained by the Imaging Core to ensure the efficient generation of study findings and access to the data repository by investigators in the scientific community locally, regionally, and nationally. These activities will streamline recruitment, the evaluation of eligibility, the collection of research data, and the seamless integration of clinical and imaging activities for all pilot projects proposed in the Center. Finally, the Clinical Core will provide regulatory assistance to pilot project investigators to ensure compliance with all local and national regulatory requirements. These contributions will help the PACE provide unique insights into the risk and pathophysiology of OUD and the identification and development of more efficacious treatments for pain and OUD.

临床核心 宾夕法尼亚大学PET成瘾卓越中心（PACE）将提供所需的基础设施和资源， 促进PET神经成像研究，目前正在进行资助的临床成瘾研究， 宾夕法尼亚大学和耶鲁大学医学院临床核心将提供开展所需的临床服务 计划中的试点项目和随后在P30赠款期第二年开始确定的项目。的 临床核心将利用成瘾研究中心现有的临床研究资源， 在PSOM建立了中心，费城的其他临床资源，以及康涅狄格州纽黑文的临床资源。的 临床核心将在招募和评估阿片类药物使用患者方面提供专业知识 疾病（OUD）和健康对照受试者（HC）。为了招募OUD受试者，临床中心将 与附近的两个住宅成瘾治疗计划，柯克布赖德中心和斯奈德之家， 在这三个月内，病人会被戒毒，并保持不吸毒。这些方案都是在 宾夕法尼亚大学在费城的校园，这确保病人可以很容易地运送到PET设施， 显像康涅狄格州精神健康中心的临床神经科学研究单位将提供类似的 耶鲁大学的OUD患者。临床核心还将招募、筛选和评估阿片类药物样本- 暴露的HC，其将在关键变量上与OUD受试者匹配。使用一组核心评估， 其中将增加项目特定的评估和程序，临床核心将促进联合 分析试点项目的结果，使研究人员能够比较接受成像的HC 使用一种以上的PET配体。临床核心还将管理临床数据及其与 由Imaging Core获得的数据，以确保有效生成研究结果和访问数据 地方、区域和国家科学界的研究人员建立了一个知识库。这些活动将 简化招聘、资格评估、研究数据收集，并实现无缝整合 该中心提出的所有试点项目的临床和成像活动。最后，临床核心将提供 为试点项目调查人员提供监管协助，以确保遵守所有当地和国家监管规定 要求.这些贡献将有助于PACE提供对风险和病理生理学的独特见解。 以及识别和开发更有效的疼痛和OUD治疗方法。