Yale Tobacco Center of Regulatory Science

描述（由申请人提供）：《家庭吸烟预防和烟草控制法》授权FDA监管烟草制品，使减少所有烟草制品的吸引力、成瘾性和有害影响的关键目标更容易实现，包括当前和新兴的改性风险烟草制品（MRTP）。耶鲁大学烟草管理科学中心的首要目标是通过建立一个强大的知识基础，了解包括薄荷醇和甜味剂在内的香料如何影响对现有烟草和改良风险烟草产品上瘾的开始和发展，从而减少成瘾。从本质上讲，这四项拟议的研究是基础科学、临床科学和人口科学的桥梁。耶鲁大学tors多学科团队包括化学感觉心理物理学（Barry Green）、薄荷醇和刺激受体生物学(Sven Jordt；Green)，大脑奖励通路中的多巴胺能信号传导（Nil Addy），尼古丁受体生物学（Marina Picciotto），青少年烟草使用（Suchitra Krishnan-Sarin），人类行为药理学（Mehmet Sofuoglu），烟草成瘾（Stephanie O'Malley/Benjamin Toll），滥用药物的临床药代动力学（Peter Jatlow）以及卫生经济学和决策科学（Jody Sindelar/Johanna Maclean）。拟建中心的具体目标如下：1)激发跨学科的研究兴趣，并为FDA提供可用于制定减少烟草制品成瘾性政策的经验证据；2)开展一系列程序性研究，以了解香料和甜味剂（包括薄荷醇）在调节烟草制品成瘾性方面的作用；3)培养具有监管研究经验并能综合多学科证据以制定烟草政策的新一代研究人员；4)通过使用标准化措施和方法，促进中心内部和中心之间的合作，以及合作研究项目的发展；5)为支持耶鲁tcos和其他tcos目标的试点项目提供快速审查和资助机制。同时也对FDA的持续监管需求做出反应。

DESCRIPTION (provided by applicant): The Family Smoking Prevention and Tobacco Control Act, by empowering the FDA to regulate tobacco products, makes the crucial goal of reducing the appeal, addiction, and harmful effects of all tobacco products, including current and emerging modified risk tobacco products (MRTP's) more achievable. The overarching goal of the Yale Tobacco Center of Regulatory Science is to reduce addiction by developing a strong knowledge base on how flavors, including menthol, and sweeteners affect the initiation and development of addiction to current tobacco and modified risk tobacco products. Translational in nature, the four proposed studies bridge basic, clinical and population science. The Yale TCORS multidisciplinary team includes experts in chemosensory psychophysics (Barry Green), menthol and irritant receptor biology (Sven Jordt; Green), dopaminergic signaling in brain reward pathways (Nil Addy), nicotinic receptor biology (Marina Picciotto), adolescent tobacco use (Suchitra Krishnan-Sarin), human behavioral pharmacology (Mehmet Sofuoglu), tobacco addiction (Stephanie O'Malley/Benjamin Toll), clinical pharmacokinetics of drugs of abuse (Peter Jatlow), and health economics and decision making science (Jody Sindelar/Johanna Maclean).The proposed center addresses the following specific aims: 1) To galvanize research interest across disciplines and to provide the FDA with empirical evidence that might be used to develop policies to reduce addiction to tobacco products, 2) To conduct a series of programmatic studies to understand the role of flavors and sweeteners, including menthol, in modulating addictive potential of tobacco products, 3) To train a new generation of researchers who have experience in regulatory research and can synthesize evidence from multiple disciplines to generate tobacco policies, 4) To facilitate collaborations within and across centers through the use of standardized measures and methods, and development of collaborative research projects, 5) To provide a mechanism for rapid review and funding of pilot projects which support the goals of the Yale TCORS and other TCORS, and are also responsive to the ongoing regulatory needs of the FDA. RELEVANCE: This center will conduct programmatic research to examine the influence of flavors, and related factors, on preference for and addiction to tobacco products. The center will also train a new generation of scientists, and provide pilot funding to stimulate research related to tobacco regulatory science. This comprehensive effort will help the FDA develop science based policies to reduce addiction to tobacco products.