Yale Tobacco Center of Regulatory Science

《家庭吸烟预防和烟草控制法》通过授权FDA监管烟草产品，使减少所有烟草产品（包括当前和新出现的改良风险烟草产品（MRTP））的吸引力、成瘾性和有害影响的关键目标更容易实现。耶鲁烟草监管科学中心的首要目标是通过开发一个强大的知识库来减少成瘾，该知识库涉及包括薄荷醇和甜味剂在内的香料如何影响对当前烟草和改良风险烟草产品成瘾的启动和发展。这四项拟议的研究在本质上是转化性的，是基础科学、临床科学和人口科学的桥梁。耶鲁TCORS多学科团队包括化学感觉心理物理学专家（巴里绿色），薄荷醇和刺激性受体生物学（斯文·约尔特;绿色），大脑奖赏通路中的多巴胺能信号（尼尔艾迪），烟碱受体生物学（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），药物滥用的临床药代动力学（彼得·贾特洛），卫生经济学和决策科学（乔迪·辛德拉尔/约翰娜·麦克莱恩）.拟议中的中心致力于实现以下具体目标：1）激发跨学科的研究兴趣，并为FDA提供经验证据，可用于制定减少烟草产品成瘾的政策，2）进行一系列计划性研究，以了解香料和甜味剂的作用，包括薄荷醇，3）培养新一代研究人员，他们具有监管研究的经验，能够综合多学科的证据制定烟草政策，4）通过使用标准化的措施和方法，促进中心内部和跨中心的合作，并开发合作研究项目，5）为支持耶鲁TCORS和其他TCORS目标的试点项目提供快速审查和资助机制，并对FDA的持续监管需求做出响应。 相关性：该中心将进行项目研究，以检查口味和相关因素对烟草产品偏好和成瘾的影响。该中心还将培训新一代科学家，并提供试点资金，以刺激与烟草监管科学有关的研究。这一全面的努力将有助于FDA制定以科学为基础的政策，以减少对烟草产品的成瘾。

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.