Medication Development Center for cocaine Use Disorder

可卡因使用障碍药物开发中心

• 批准号: 8842317
• 负责人: FREDERICK Gerard MOELLER
• 金额: $ 121.97万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8842317
• 关键词: Agonist; Brain; Clinical; Clinical Data; Clinical Trials; Cocaine; Data; Development; Disease; Dose; Drug Industry; Drug Interactions; Goals; HTR2A gene; Human; Institution; National Institute of Drug Abuse; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Research; Research Personnel; Resources; Safety; Self Administration; Training; Translational Research; addiction; base; cocaine use; cue reactivity; disorder later incidence prevention; dosage; industry partner; neuroimaging; novel; pre-clinical; preclinical study; receptor; response; tool

 DESCRIPTION (provided by applicant): This U54 Center will use translational research from brain to bedside as a tool for medication development in cocaine use disorder. Preclinical and early phase I clinical PK/PD data will provide information for go/no-go decisions on phase ll-lll clinical trials with medications that show promise for cocaine use disorder. The overall goal of this research is to create a center that can provide important preclinical and early phase I clinical data to NIDA and pharmaceutical industry partners on novel compounds for cocaine use disorder. The aims related to the theme of the center will be achieved through two cores and three projects: The Administrative Core (F. Gerard Moeller PI) serves as a general resource for the other Projects and the Educational Core, including oversight of fiscal and compliance matters, and will oversee interactions with outside entities including NIDA and the pharmaceutical industry. The Educational Core (William L. Dewey PI) will focus on training translational researchers for medication development for addictions across the two institutions. Project 1 (F. Gerard Moeller PI) is a Phase I human drug interaction study examining the safety of concurrent administration of cocaine with novel compounds, and the effects of the novel compounds on subjective response to cocaine and cocaine self-administration in non-treatment seeking CocUD subjects. The compounds to be studied will be the 5-HTac receptor agonist lorcaserin followed by the 5-HT2A receptor antagonist pimavanserin based on results of Project 3. Project 2 (Joel L. Steinberg PI) is a human neuroimaging study to determine the dose-related effects of the novel compounds (lorcaserin followed by pimavanserin) on brain function during cue reactivity tasks in abstinent CocUD subjects to provide further information on specific dosages and further evidence for go/no-go decisions on phase II clinical trials using medications as a tool to enhance relapse prevention. Project 3 (Kathryn C. Cunningham PI) is a preclinical study examining the effects of novel compounds (pimavanserin and pimavanserin plus lorcaserin) on self-administration and cue reactivity to fill in key information that is lacking on potential compounds for CocUD and will provide important information to support or refute phase I human studies.

 描述（由应用程序提供）：该U54中心将使用从大脑到床边的转化研究作为可卡因使用障碍药物开发的工具。临床前和I期临床PK/PD数据将提供有关LL-LLL临床试验的GO/NO-GO决策的信息，该试验显示出对可卡因使用障碍有望的药物。这项研究的总体目的是创建一个中心，该中心可以为NIDA和制药行业合作伙伴提供重要的临床前和早期I期临床数据，以解决可卡因使用障碍的新颖化合物。与中心主题相关的目的将通过两个核心和三个项目来实现：行政核心（F. Gerard Moeller Pi）是其他项目和教育核心的一般资源，包括对财政和合规性的监督，并将监督与NIDA和包括NIDA和制药行业在内的外部实体的互动。 Core（William L. Dewey Pi）将专注于培训翻译研究人员为两家机构增加的药物开发。项目1（F. Gerard Moeller Pi）是一项I期人类药物相互作用研究，检查了安全性 同时施用可卡因与新颖的化合物，以及新化合物对可卡因和可卡因自我给药的主观反应的影响，在寻求Cocud受试者的非治疗中。待研究的化合物将是5-HTAC受体激动剂Lorcasein，其次是5-HT2A受体拮抗剂皮马万塞蛋白基于项目3的结果。 Cocud受试者提供有关特定剂量的进一步信息，以及使用药物作为增强预防继电器预防的工具进行II期临床试验的进一步证据。项目3（Kathryn C. Cunningham Pi）是一项临床前研究，研究了新型化合物（Pimavanserin和pimavanserin plus lorcasein）对自我管理和提示反应性的影响，以填补缺乏对关键信息的反应性，这些信息缺乏关键信息 Cocud的潜在化合物，并将提供重要的信息来支持或驳斥I期人类研究。