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案》通过授权FDA监管烟草产品，使减少所有烟草产品的吸引力、成瘾性和有害影响的关键目标更容易实现，包括当前和正在出现的修改风险烟草产品(MRTP)。耶鲁烟草监管科学中心的总体目标是通过建立一个强大的知识库，了解包括薄荷醇和甜味剂在内的味道如何影响对当前烟草和修饰风险烟草产品的成瘾的开始和发展，从而减少成瘾。在翻译的性质上，这四项拟议的研究是基础、临床和人口科学的桥梁。耶鲁大学TCORS多学科团队包括化学感觉心理物理学(Barry Green)、薄荷醇和刺激剂受体生物学(Sven Jordan t；)、大脑奖赏通路中的多巴胺能信号(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)以及健康经济学和决策科学(Jody Sindelar/Johanna Maclean)。拟建的中心致力于以下具体目标：1)激发跨学科的研究兴趣，并为FDA提供经验证据，这些证据可用于制定政策，以减少对烟草产品的依赖2)开展一系列程序性研究，以了解包括薄荷醇在内的香料和甜味剂在调节烟草产品成瘾潜力中的作用；3)培训新一代研究人员，他们在监管研究方面有经验，能够综合多学科的证据来制定烟草政策；4)通过使用标准化的措施和方法，促进中心内和中心之间的合作，并开发合作研究项目；5)提供一种机制，用于快速审查和资助试点项目，以支持耶鲁TCORS和其他TCORS的目标，并响应FDA正在进行的监管需求。 相关性：该中心将进行程序性研究，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相关的研究。这一全面的努力将帮助FDA制定基于科学的政策，以减少对烟草产品的上瘾。

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.