The Ohio State University Tobacco Center of Regulatory Science (OSU-TCORS)

俄亥俄州立大学烟草监管科学中心 (OSU-TCORS)

• 批准号: 10666066
• 负责人: Peter G. Shields
• 金额: $ 399.25万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-14 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666066
• 关键词: 3-Dimensional; Address; Adult; Advocate; Affect; Behavior; Biological Availability; Characteristics; Chemicals; Cigarette; Communication; Congresses; Data; Decision Making; Dermal; Dimensions; Drug Kinetics; Electronic cigarette; Environment; Evaluation; Faculty; Flavoring; Fostering; Goals; Health; Human; Industry; Intervention Studies; Isomerism; Laboratory Study; Marketing; Metabolism; Modeling; Monitor; Nicotine; Nicotine Withdrawal; Observational Study; Occupational activity of managing finances; Ohio; Oral; Pattern; Persons; Population; Postdoctoral Fellow; Public Health; Regulation; Research Personnel; Research Project Grants; Rewards; Risk; Sales; Science; Sensory; Signal Transduction; Smoke; Smokeless Tobacco; Smoker; Testing; Time; Tobacco; Tobacco Industry; Tobacco Surveillance; Tobacco use; Toxic effect; Toxicology; United States Food and Drug Administration; Universities; Withdrawal Symptom; Youth; absorption; abuse liability; addiction; addiction liability; career; demographics; design; electronic cigarette use; electronic liquid; experience; improved; nicotine craving; nicotine use; population health; prevent; psychologic; response; risk perception; satisfaction; smokeless tobacco use; smokeless tobacco user; student training; tobacco products; tobacco regulatory science; tobacco user; tool; uptake

OVERALL PROJECT SUMMARY Nicotine is the most important driver of tobacco use. The tobacco industry's manipulation of nicotine in cigarettes and smokeless tobacco led to products that were more addictive, abused, and deadly. With “starter” products for young people and nicotine-naïve users and “mature” products for established tobacco users, the industry has historically manipulated the “levers” of nicotine concentration and form to increase tobacco use across all demographics. E-cigarettes (ECs) and more recently oral nicotine pouches (ONPs) vary these nicotine dimensions signaling that the industry is again following this profit-driven strategy. Recent advancements in nicotine synthesis also makes nicotine isomer a new product lever that the industry can adjust to drive consumer uptake through changes in pharmacokinetics and misleading marketing claims. While the US Congress and FDA have imposed important regulations to dissuade tobacco use among young people, we argue that the regulation of nicotine itself may be the most effective strategy to achieve optimal population health. Like the tobacco industry, the FDA can pull these same levers via product standards and marketing regulations to adjust the appeal and addiction potential of ECs and ONPs. Through our integrative theme, “Flipping the Script”: Using the Industry's Nicotine Playbook to Maximize Public Health, the Ohio State University Tobacco Center of Regulatory Science (OSU-TCORS) will be guided by the industry's Consumer Response Model to understand how nicotine in ECs and ONPs are impacting product appeal, addictiveness, use patterns, and toxicity. We posit that regulation of nicotine's three dimensions can dissuade young people, including non-users, from using ECs and ONPs but still provide a satisfying and less harmful alternative for adult tobacco users for complete switching. Project 1 (P1) and P2 will examine the influence of EC and ONP nicotine manipulations on product appeal, abuse liability, use, and toxicity; P3, using ONPs as an exemplar product, will examine the influence of nicotine marketing claims on appeal and product trial; and P4 will examine how young people, including priority populations, respond to both nicotine product marketing and design characteristics in the natural environment. The projects are supported by the Market Monitoring Core that will provide critical real-time marketing and purchasing of products by venue and the Product Evaluation and Manipulation Core that studies products varied by nicotine dimensions with chemical and toxicological analysis. They also will be supported by the Administrative Core. The Career Enhancement Core will foster the training of students, postdoctoral fellows, and early career investigators in tobacco regulatory science. Together, the OSU-TCORS addresses the FDA priority scientific domains of Product Composition and Design, Toxicity, Addiction, Health Effects, Behavior, and Marketing Influences. The projects are highly integrated and will provide the FDA with critical, first-of-its-kind data by conducting complementary interventional and observational studies to inform the Consumer Response Model as a tool to protect public health.

总体项目摘要 尼古丁是烟草使用的最重要驱动因素。烟草业在香烟中操纵尼古丁 无烟的烟草导致了更具添加剂，滥用和致命的产品。带有“入门”产品 对于年轻人和尼古丁的用户和固定烟草用户的“成熟”产品，该行业拥有 从历史上看，操纵尼古丁浓度和形式的“杠杆”，以增加所有人的烟草使用 人口统计。电子烟（ECS）和最近的口服尼古丁小袋（ONPS）改变了这些尼古丁 维度表明该行业再次遵循这种利润驱动的策略。最近的进步 尼古丁的合成还使尼古丁异构体成为新产品杆，行业可以适应以推动消费者 通过改变药代动力学和误导营销主张来吸收。而美国国会和FDA 我们规定了在年轻人中劝阻烟草使用的重要法规，我们认为该法规 尼古丁本身可能是实现最佳人口健康的最有效策略。喜欢烟草 行业，FDA可以通过产品标准和营销法规拉动相同的杠杆来调整 EC和ONP的吸引力和成瘾潜力。通过我们集成的主题“翻转脚本”：使用 该行业的尼古丁剧本，以最大化公共卫生，俄亥俄州立大学烟草中心 监管科学（OSU-TCORS）将以行业的消费者响应模型为指导 ECS和ONP中的尼古丁如何影响产品外观，添加性，使用模式和毒性。我们的位置 尼古丁三维的调节可以阻止包括非用户在内的年轻人使用ECS ONPS，但仍然为成人烟草用户提供令人满意且危害不足的替代方案，以使其完全切换。 项目1（P1）和P2将检查EC和ONP尼古丁操纵对产品外观的影响， 滥用责任，使用和毒性； P3使用ONP作为示例性产品，将检查尼古丁的影响 上诉和产品试用的营销主张； P4将检查年轻人，包括优先事项 人群，对尼古丁产品营销以及自然环境中的设计特征做出反应。 这些项目得到了市场监控核心的支持，该核心将提供关键的实时营销和 通过场地购买产品以及研究产品的产品评估和操纵核心 随着化学和毒理学分析的尼古丁尺寸而变化。他们还将得到 行政核心。职业增强核心将促进学生的培训，博士后研究员， 以及烟草监管科学的早期职业调查员。 OSU-TCOR一起解决了FDA 产品组成和设计的优先科学领域，毒性，成瘾，健康影响，行为和 营销影响。这些项目是高度整合的，将为FDA提供关键的，首先 通过进行完整的介入和观察性研究来告知消费者反应的数据 模型作为保护公共卫生的工具。