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Medication Development Center for cocaine Use Disorder

可卡因使用障碍药物开发中心

基本信息

批准号：
9729182
负责人：
FREDERICK Gerard MOELLER
金额：
$ 49.97万
依托单位：
VIRGINIA COMMONWEALTH UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-15 至 2020-07-31
项目状态：
已结题

项目摘要

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（由申请人提供）：该 U54 中心将利用从大脑到临床的转化研究作为可卡因使用障碍药物开发的工具。临床前和早期 I 期临床 PK/PD 数据将为 II-III 期临床试验的进行/不进行决策提供信息，这些试验的药物显示出治疗可卡因使用障碍的前景。这项研究的总体目标是建立一个中心，可以向 NIDA 和制药行业合作伙伴提供有关治疗可卡因使用障碍的新型化合物的重要临床前和早期 I 期临床数据。与该中心主题相关的目标将通过两个核心和三个项目来实现：行政核心（F. Gerard Moeller PI）作为其他项目和教育核心的一般资源，包括监督财务和合规事务，并将监督与包括 NIDA 和制药行业在内的外部实体的互动。教育核心（William L. Dewey PI）将重点培训两个机构的成瘾药物开发转化研究人员。项目 1（F. Gerard Moeller PI）是一项 I 期人类药物相互作用研究，检查安全性可卡因与新化合物同时给药的研究，以及新化合物对非治疗寻求 CocUD 受试者对可卡因和可卡因自我给药的主观反应的影响。根据项目 3 的结果，待研究的化合物将是 5-HTac 受体激动剂 lorcaserin，随后是 5-HT2A 受体拮抗剂 pimavanserin。项目 2（Joel L. Steinberg PI）是一项人类神经影像研究，旨在确定新型化合物（lorcaserin，随后是 pimavanserin）在提示反应任务期间对大脑功能的剂量相关影响。戒断 CocUD 受试者，以提供有关具体剂量的进一步信息，以及使用药物作为加强预防复发的工具的 II 期临床试验中进行/不进行决策的进一步证据。项目 3（Kathryn C. Cunningham PI）是一项临床前研究，检查新型化合物（pimavanserin 和 pimavanserin 加 lorcaserin）对自我给药和提示反应性的影响，以填补缺乏的关键信息。 CocUD 的潜在化合物，并将为支持或反驳 I 期人体研究提供重要信息。

项目成果

期刊论文数量（9）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Attentional function and inhibitory control in different substance use disorders.

DOI：
10.1016/j.psychres.2022.114591
发表时间：
2022-07
期刊：
PSYCHIATRY RESEARCH
影响因子：
11.3
作者：
Bjork, James M.;Keyser-Marcus, Lori;Vassileva, Jasmin;Ramey, Tatiana;Houghton, David C.;Moeller, F. Gerard
通讯作者：
Moeller, F. Gerard

Cingulo-hippocampal effective connectivity positively correlates with drug-cue attentional bias in opioid use disorder.

DOI：
10.1016/j.pscychresns.2019.08.005
发表时间：
2019-12-30
期刊：
Psychiatry research. Neuroimaging
影响因子：
0
作者：
Ma L;Steinberg JL;Bjork JM;Taylor BA;Arias AJ;Terplan M;Anastasio NC;Zuniga EA;Lennon M;Cunningham KA;Moeller FG
通讯作者：
Moeller FG

Suppression of cocaine relapse-like behaviors upon pimavanserin and lorcaserin co-administration.

DOI：
10.1016/j.neuropharm.2020.108009
发表时间：
2020-05-15
期刊：
Neuropharmacology
影响因子：
4.7
作者：
Anastasio NC;Sholler DJ;Fox RG;Stutz SJ;Merritt CR;Bjork JM;Moeller FG;Cunningham KA
通讯作者：
Cunningham KA

Death Ambivalence and Treatment Seeking: Suicidality in Opiate Addiction.

死亡矛盾心理和寻求治疗：阿片成瘾的自杀倾向。