Medication Development Center for cocaine Use Disorder

U54中心将使用从大脑到床边的翻译研究作为药物开发的工具 可卡因使用障碍。临床前和早期I期临床PK/PD数据将为GO/NO-GO提供信息 关于第二-第三阶段临床试验的决定，这些试验使用的药物显示出可卡因使用障碍的前景。这个 这项研究的总体目标是创建一个中心，能够提供重要的临床前和早期I期 向NIDA和制药行业合作伙伴提供治疗可卡因使用障碍的新化合物的临床数据。 与中心主题有关的目标将通过两个核心和三个项目实现： 管理核心(F.Gerard Moeller Pi)作为其他项目和 教育核心，包括监督财政和合规事项，并将监督与 外部实体，包括NIDA和制药业。《教育核心》(威廉·L·杜威·派) 将专注于培训翻译研究人员，为两地的成瘾药物开发提供培训 机构。项目1(F.Gerard Moeller Pi)是一项第一阶段的人类药物相互作用研究，旨在检查安全性 可卡因与新化合物同时给药的情况，以及新化合物对 未寻求治疗的慢性阻塞性肺病患者对可卡因和可卡因自我给药的主观反应。 待研究的化合物将是S-HTAC受体激动剂氯酪蛋白，然后是5-HT2a受体 基于项目3的结果的拮抗剂pimavanserin。项目2(Joel L.Steinberg Pi)是人类 神经成像研究以确定新化合物的剂量相关效应(氯酪氨酸和 Pimavanserin)对戒断CocUD受试者线索反应任务中脑功能的影响 关于特定剂量的信息和关于第二阶段临床试验进行/不进行决策的进一步证据 将药物作为加强复发预防的工具。项目3(Kathryn C.Cunningham Pi)是一个临床前阶段 新型化合物(吡喃色林及其与氯酪蛋白联用)对自身给药影响的研究 并提示反应性，以填充缺乏CocUD潜在化合物的关键信息 并将为支持或驳斥第一阶段人类研究提供重要信息。

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 II-III 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 S-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.