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.

项目总体概要 尼古丁是烟草使用最重要的驱动因素。烟草业对香烟中尼古丁的操纵 无烟烟草导致产品更容易上瘾、滥用和致命。带有“入门”产品 对于年轻人和未接触过尼古丁的使用者，以及针对老牌烟草使用者的“成熟”产品，该行业已经 历史上操纵尼古丁浓度和形式的“杠杆”来增加所有人的烟草使用 人口统计。电子烟 (EC) 和最近的口服尼古丁袋 (ONP) 改变了这些尼古丁 尺寸表明该行业再次遵循这种利润驱动的策略。最近的进展 尼古丁合成也使尼古丁异构体成为行业可以调整以驱动消费者的新产品杠杆 通过药代动力学的变化和误导性的营销宣传来吸收。虽然美国国会和FDA 已经制定了重要的法规来阻止年轻人使用烟草，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。就像烟草一样 行业中，FDA 可以通过产品标准和营销法规来拉动这些相同的杠杆来调整 EC 和 ONP 的吸引力和成瘾潜力。通过我们的综合主题“翻转脚本”：使用 俄亥俄州立大学烟草中心的行业尼古丁手册，以最大限度地提高公众健康 监管科学（OSU-TCORS）将以行业消费者响应模型为指导来了解 EC 和 ONP 中的尼古丁如何影响产品吸引力、成瘾性、使用模式和毒性。我们假设 对尼古丁三个维度的监管可以阻止年轻人（包括非使用者）使用电子烟 和 ONP，但仍为成年烟草使用者提供一种令人满意且危害较小的替代品，以实现完全戒烟。 项目 1 (P1) 和 P2 将研究 EC 和 ONP 尼古丁操纵对产品吸引力的影响， 滥用倾向、用途和毒性； P3将使用ONP作为示例产品来研究尼古丁的影响 上诉和产品试用的营销主张； P4 将研究年轻人如何，包括优先考虑 人群对尼古丁产品营销和自然环境中的设计特征做出反应。 这些项目得到市场监控核心的支持，该核心将提供关键的实时营销和 按场所购买产品以及研究产品的产品评估和操作核心 通过化学和毒理学分析，尼古丁含量有所不同。他们也将得到以下机构的支持 行政核心。职业发展核心将促进学生、博士后研究员、 以及烟草监管科学领域的早期职业研究者。 OSU-TCORS 共同向 FDA 提出要求 产品成分和设计、毒性、成瘾性、健康影响、行为和 营销影响。这些项目高度集成，将为 FDA 提供关键的、史无前例的 通过进行补充性干预和观察研究来了解数据，以告知消费者反应 模型作为保护公众健康的工具。