Yale Center for the Study of Tobacco Product Use and Addiction (YCSTP)

总体-摘要 美国食品和药物管理局有权监管烟草产品以保护公众健康。 针对有助于烟草产品吸引力和成瘾的成分的监管措施 是非常需要的。美国食品和药物管理局（FDA）已提出计划，以规范香烟和香料中的尼古丁浓度， 许多烟草产品，需要严格的科学证据来支持这些计划，并捍卫法律的 挑战目前，我们对尼古丁和香料添加剂如何影响 烟草产品的吸引力和成瘾性，以及这些成分如何影响发起和支持 减少伤害。此外，最近针对尼古丁和香料添加剂的“破坏性创新”， 烟草业的影响，带来了新的未知数为了解决这些知识差距，耶鲁中心 烟草制品研究中心（YCSTP）汇集了一个多学科团队， 不同形式和浓度的尼古丁（烟草衍生的、合成的、游离碱/盐）的影响， 添加冷却的成分（薄荷醇、无味合成冷却剂），以及添加 通过不同途径和产品（口服，吸入， 静脉注射）对启动、成瘾和减少伤害的作用。项目1（Jordt/Addy）将检查是否无气味 清凉香料、甜味剂、保湿剂和不同的尼古丁立体异构体影响引发，尼古丁 偏好、强化和从青少年到成年的使用过渡。项目2（Sofuoglu）将 确定尼古丁强化、辨别和主观奖励的阈值是否被尼古丁改变 依赖和接触甜味剂。项目3（Krishnan-Sarin）将检查是否无味合成冷却剂 和合成尼古丁外消旋混合物改变了含尼古丁的电子烟的吸引力和成瘾潜力， 香烟项目4（Fucito/Bold）将研究香料和尼古丁的潜在法规的影响 在不可燃烟草产品（尼古丁袋，电子烟）中的浓度从 可燃烟草制品YCSTP将得到测量和分析核心的支持 （Morean/Gueorguieva），将提供和发展心理测量上的健全措施和严格的统计数据， 分析，一个实验室核心（Eid/齐默尔曼），将提供新的和现有的烟草化学分析 烟草/尼古丁暴露和健康/毒性生物标志物的产品和生物估计，职业生涯 增强核心（奥马利/香港），将培训研究员和初级教师在烟草监管科学， 提供试点资金，以及一个行政核心（Krishnan-Sarin/O 'Malley），以确保产生 通过科学、监管和社区监督，以及促进内部和内部 TCORS通信和协作。我们将建立在我们以前的TCORS的方法和发现的基础上 并将动物模型中的生物学和行为学测试与 为烟草制品中尼古丁和香料添加剂的监管提供了坚实的科学基础。

OVERALL - ABSTRACT The US Food and Drug Administration has the authority to regulate tobacco products to protect public health. Regulatory measures that address constituents that contribute to the appeal and addiction of tobacco products are critically needed. The FDA has proposed plans to regulate nicotine concentration in cigarettes and flavors in many tobacco products and needs rigorous scientific evidence to support these plans and defend legal challenges. Currently, important gaps remain in our understanding of how nicotine and flavor additives influence the appeal of and addiction to tobacco products and how these constituents might influence initiation and support harm reduction. Moreover, recent “disruptive innovations” directed at nicotine and flavor additives and introduced by the tobacco industry, have led to new unknowns. To address these gaps in knowledge, the Yale Center for the Study of Tobacco Products (YCSTP) brings together a multidisciplinary team to investigate the effects of different forms and concentrations of nicotine (tobacco-derived, synthetic, freebase/salt), constituents that add cooling (menthol, odorless synthetic coolants), and constituents that add sweetness (humectants, sweeteners) delivered via different routes and products (oral, inhaled, intravenous) on initiation, addiction and harm reduction. Project 1 (Jordt/Addy) will examine if odorless cooling flavors, sweeteners, humectants, and different nicotine stereoisomers impact initiation, nicotine preference, reinforcement, and transitions in use form adolescence to adulthood. Project 2 (Sofuoglu) will determine if thresholds for nicotine reinforcement, discrimination, and subjective reward are altered by nicotine dependence and exposure to sweeteners. Project 3 (Krishnan-Sarin) will examine if odorless synthetic coolants and synthetic nicotine racemic mixtures alter the appeal and addiction potential of nicotine-containing e- cigarettes. Project 4 (Fucito/Bold) will examine the impact of potential regulations of flavors and nicotine concentration in non-combustible tobacco products (nicotine pouches, e-cigarettes) on switching from combustible tobacco products. The YCSTP will be supported by a Measurement and Analytics Core (Morean/Gueorguieva) that will provide and develop psychometrically sound measures and rigorous statistical analyses, a Laboratory Core (Eid/Zimmerman) that will provide chemical analyses of new and existing tobacco products and biological estimates of tobacco/nicotine exposure and health/toxicity biomarkers, a Career Enhancement Core (O’Malley/Kong) that will train fellows and junior faculty in tobacco regulatory science and provide pilot funding, and an Administrative Core (Krishnan-Sarin/O’Malley) that will ensure the generation of rigorous science through scientific, regulatory, and community oversight as well as facilitate intra- and inter- TCORS communications and collaborations. We will build on the methods and findings from our prior TCORS and integrate biological and behavioral testing in animal models with behavioral and pharmacological testing in humans to generate a firm scientific foundation for regulation of nicotine and flavor additives in tobacco products.