Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine and Other Constituents (YCSTP)

耶鲁大学烟草产品使用和成瘾研究中心：香料、尼古丁和其他成分 (YCSTP)

• 批准号: 10475346
• 负责人: SUCHITRA KRISHNAN-SARIN
• 金额: $ 11.69万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10475346
• 关键词: Address; Adolescent; Advanced Development; Animal Model; Behavior; Biological; Biological Markers; Biological Testing; Brain; Chemicals; Cigarette; Cigarette Smoker; Collaborations; Development; Devices; Dose; Electronic cigarette; Ensure; Faculty; Family Smoking Prevention and Tobacco Control Act; Foundations; Funding; Future; Goals; Grant; Harm Reduction; Heart; Human; Inhalation; Knowledge; Laboratories; Maintenance; Manuscripts; Measures; Menthol; Mentorship; Methods; Nicotine; Nicotine Withdrawal; Nicotinic Receptors; Oral; Paper; Pharmacology; Physiological; Pilot Projects; Policies; Psychological reinforcement; Public Health; Publishing; Regulation; Research; Research Personnel; Research Project Grants; Research Support; Role; Sarin; Science; Scientist; Self Administration; Series; Sex Differences; Smokeless Tobacco; Sweetening Agents; Taste Perception; Testing; Tobacco; Tobacco Dependence; Tobacco smoke; Tobacco use; Training; United States National Institutes of Health; Withdrawal; Youth; addiction; age related; behavior test; behavioral pharmacology; career; career development; combustible tobacco; e-cigarette aerosols; electronic cigarette use; evidence base; experience; improved; innovation; interdisciplinary approach; irritation; mature animal; multidisciplinary; next generation; nicotine exposure; nicotine inhalation; nicotine reward; nicotine use; novel; pre-clinical; preconditioning; preference; prevent; response; standardize measure; tobacco products; tobacco regulation; tobacco regulatory science; tobacco user; trend; vapor

Overall Abstract: YCSTP Tobacco use and addiction remain among the top 10 public health problems in the USA19 To protect the public health, regulatory measures that lessen the appeal and abuse liability of tobacco products are critically needed (WHO-FCTC, 2012). The Family Smoking Prevention and Tobacco Control Act (FSPTCA) prohibits the addition of characterizing artificial or natural flavors to tobacco cigarettes. However, menthol is exempt and other tobacco products include a wide variety of flavors. Further regulations of flavors depend on research addressing the significant gap in our understanding of the influence of flavors on the appeal of tobacco/nicotine and the initiation, progression and maintenance of tobacco use18. To address this knowledge gap, the YCSTP uses a multidisciplinary approach to generate essential TRS evidence in the FDA priority domains, Behavior and Addiction. Toward this end, we will examine the role of different classes of flavors (sweet and cool) including sweeteners and novel cool flavors, on initiation, continued use and addiction to nicotine/tobacco, and their relevance to harm reduction. We will build on the methods and findings generated in Yale TCORS-1, 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 flavors and nicotine in tobacco products. Project 1 (Jordt/Addy) will use novel and established pre-clinical paradigms to paradigms to examine if preconditioning to flavors and sweeteners influences emergence of nicotine use behaviors and addiction, and the influence of novel cooling agents that may ultimately replace menthol in tobacco products. Project 2 (Krishnan-Sarin/Green) will examine the influence of sweet and cool flavors on initiation behaviors among human youth who are relatively early on the tobacco initiation spectrum and are susceptible to future use. This project will also examine if sweet and cool flavors are differentially important for altering nicotine reward, and facilitating switching behaviors, in younger and older combustible tobacco users. Project 3 (Sofuoglu) will determine the optimal delivery rates that are needed by combustible tobacco users to relieve nicotine withdrawal while producing minimal positive effects, and whether the influence of this delivery rate is altered if combustible tobacco users switch from using mentholated to non-mentholated products. YCSTP goals will be supported by 1) an administrative core that will facilitate and ensure successful completion of all proposed and new research and support collaborations within and across YCSTP, other TCORS, NIH and FDA-CTP, 2) a laboratory core that will provide critical analyses of tobacco products, vapor as well as markers of biological exposure to nicotine and flavors, and 3) by a career enhancement core that will promote the development of fellows and junior faculty as independent TRS investigators. The YCSTP will also use multidisciplinary core expertise to respond to “Rapid Response Project” announcements focused on FDA-CTP needs and the goals of the YCSTP.

总体摘要：YCSTP 烟草使用和成瘾仍然是美国十大公共卫生问题之一19 保护公众 迫切需要采取健康、监管措施来减少烟草制品的吸引力和滥用责任 （世界卫生组织《烟草控制框架公约》，2012 年）《家庭吸烟预防和烟草控制法案》（FSPTCA）禁止 在烟草中添加人工或天然香料，但薄荷醇除外。 其他烟草产品包括多种口味，对口味的进一步规定取决于研究。 解决我们对口味对烟草/尼古丁吸引力的影响的理解上的重大差距 以及烟草使用的开始、进展和维持18。 使用多学科方法在 FDA 优先领域（行为）中生成必要的 TRS 证据 为此，我们将研究不同类别的口味（甜味和凉味）的作用。 包括甜味剂和新颖的清凉口味，在开始、持续使用和成瘾尼古丁/烟草时，以及 它们与减少危害的相关性。我们将借鉴耶鲁大学 TCORS-1 中产生的方法和研究结果，以及 将动物模型中的生物学和行为测试与动物模型中的行为和药理学测试相结合 人类为烟草产品中香料和尼古丁的监管奠定坚实的科学基础。 项目 1（Jordt/Addy）将使用新颖且已建立的临床前范例来检查是否 对香料和甜味剂的预处理会影响尼古丁使用行为和成瘾的出现，以及 可能最终取代烟草产品中薄荷醇的新型清凉剂的影响项目 2。 （Krishnan-Sarin/Green）将研究甜味和凉味对儿童起始行为的影响 处于烟草起始阶段相对较早且易于未来使用的人类青少年。 该项目还将研究甜味和冷味对于改变尼古丁奖励是否有不同的重要性，以及 项目 3（Sofuoglu）将促进年轻和老年可燃烟草使用者的行为转换。 确定可燃烟草使用者缓解尼古丁所需的最佳输送率 在产生积极效果的同时退出，以及该交付率的影响是否是如果 YCSTP 的目标是从使用含薄荷醇的产品转向使用不含薄荷醇的产品。 由 1) 一个行政核心支持，该核心将促进并确保成功完成所有拟议的和 YCSTP、其他 TCORS、NIH 和 FDA-CTP 内部和之间的新研究和支持合作，2) 实验室核心将提供烟草产品、蒸汽以及生物标记物的关键分析 接触尼古丁和香料，以及 3) 通过职业增强核心，促进发展 YCSTP 还将使用多学科核心人员作为独立的 TRS 调查员。 响应专注于 FDA-CTP 需求和目标的“快速响应项目”公告的专业知识 YCSTP 的。