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)
基本信息
- 批准号:10666066
- 负责人:
- 金额:$ 399.25万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:3-DimensionalAddressAdultAdvocateAffectBehaviorBiological AvailabilityCharacteristicsChemicalsCigaretteCommunicationCongressesDataDecision MakingDermalDimensionsDrug KineticsElectronic cigaretteEnvironmentEvaluationFacultyFlavoringFosteringGoalsHealthHumanIndustryIntervention StudiesIsomerismLaboratory StudyMarketingMetabolismModelingMonitorNicotineNicotine WithdrawalObservational StudyOccupational activity of managing financesOhioOralPatternPersonsPopulationPostdoctoral FellowPublic HealthRegulationResearch PersonnelResearch Project GrantsRewardsRiskSalesScienceSensorySignal TransductionSmokeSmokeless TobaccoSmokerTestingTimeTobaccoTobacco IndustryTobacco SurveillanceTobacco useToxic effectToxicologyUnited States Food and Drug AdministrationUniversitiesWithdrawal SymptomYouthabsorptionabuse liabilityaddictionaddiction liabilitycareerdemographicsdesignelectronic cigarette useelectronic liquidexperienceimprovednicotine cravingnicotine usepopulation healthpreventpsychologicresponserisk perceptionsatisfactionsmokeless tobacco usesmokeless tobacco userstudent trainingtobacco productstobacco regulatory sciencetobacco usertooluptake
项目摘要
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
尼古丁是烟草使用最重要的驱动因素。烟草业操纵香烟中的尼古丁
无烟烟草导致了更容易上瘾、滥用和致命的产品。用“启动器”产品
为年轻人和尼古丁初体验者提供的产品和为已建立的烟草使用者提供的“成熟”产品,烟草业
历史上操纵尼古丁浓度和形式的“杠杆”,以增加所有人的烟草使用。
人口统计学电子烟(EC)和最近的口服尼古丁袋(ONP)改变了这些尼古丁
这表明该行业再次遵循这种利润驱动的战略。的最新进展
尼古丁合成也使尼古丁异构体成为一种新的产品杠杆,该行业可以调整以推动消费者
通过药代动力学变化和误导性营销声明的吸收。虽然美国国会和FDA
已经实施了重要的法规来劝阻年轻人吸烟,我们认为,
尼古丁本身可能是实现最佳人群健康的最有效策略。比如烟草
行业,FDA可以通过产品标准和营销法规来调整这些杠杆,
吸引力和成瘾潜力的EC和ONP。通过我们的综合主题,“翻转脚本”:使用
俄亥俄州州立大学烟草中心制定了行业尼古丁策略,以最大限度地提高公共健康水平
监管科学(OSU-TCORS)将由行业的消费者响应模型指导,以了解
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。我们断定
对尼古丁的三个方面进行监管可以劝阻年轻人,包括非使用者,使用EC
和ONP,但仍然为成年烟草使用者提供了令人满意且危害较小的替代品,以便完全转换。
项目1(P1)和P2将检查EC和ONP尼古丁操作对产品吸引力的影响,
滥用倾向,使用和毒性; P3,使用ONP作为示例产品,将检查尼古丁的影响
P4将研究年轻人,包括优先权,
在自然环境中,尼古丁产品的营销和设计特征都对人群产生了影响。
这些项目得到了市场监测核心的支持,该核心将提供关键的实时营销,
按地点购买产品以及研究产品的产品评估和操作核心
不同的尼古丁尺寸与化学和毒理学分析。他们还将得到
行政核心。职业提升核心将促进学生,博士后研究员,
和烟草监管科学的早期职业调查员。OSU-TCORS共同解决了FDA
优先科学领域的产品组成和设计,毒性,成瘾,健康影响,行为,
营销影响。这些项目是高度集成的,将为FDA提供关键的,
通过进行补充性干预和观察性研究来获取数据,以告知消费者的反应
作为保护公众健康的工具。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Peter G. Shields其他文献
Biochemical and molecular epidemiology of cancer.
癌症的生化和分子流行病学。
- DOI:
- 发表时间:
1991 - 期刊:
- 影响因子:0
- 作者:
Haruhiko Sugimura;Ainsley Weston;Neil E. Caporaso;Peter G. Shields;Elise D. Bowman;Metcalf Ra;Curtis C. Harris - 通讯作者:
Curtis C. Harris
Suppression of de novo antibody responses against SARS-CoV2 and the Omicron variant after mRNA vaccination and booster in patients with B cell malignancies undergoing active treatment, but maintenance of pre-existing antibody levels against endemic viruses.
在接受积极治疗的 B 细胞恶性肿瘤患者中进行 mRNA 疫苗接种和加强接种后,可抑制针对 SARS-CoV2 和 Omicron 变体的从头抗体反应,但维持针对地方性病毒的现有抗体水平。
- DOI:
10.1101/2022.03.17.22272389 - 发表时间:
2022 - 期刊:
- 影响因子:0
- 作者:
Joseph H. Azar;John P. Evans;M. Sikorski;K. Chakravarthy;Selah McKenney;I. Carmody;C. Zeng;Rachael Teodorescu;No;Jamie L. Hamon;D. Bucci;M. Velegraki;Chelsea M Bolyard;Kevin P. Weller;Sarah;Reisinger;S. Bhat;K. Maddocks;R. Gumina;N. Anastasia;Vlasova;E. Oltz;L. Saif;D. Chung;J. Woyach;Peter G. Shields;Shan;Zihai Li;M. Rubinstein - 通讯作者:
M. Rubinstein
Detection and quantification of 8-hydroxydeoxyguanosine adducts in peripheral blood of people exposed to ionizing radiation.
电离辐射暴露人群外周血中 8-羟基脱氧鸟苷加合物的检测和定量。
- DOI:
- 发表时间:
1993 - 期刊:
- 影响因子:10.4
- 作者:
Vincent L. Wilson;B. Taffe;Peter G. Shields;Andrew C. Povey;Curtis C. Harris - 通讯作者:
Curtis C. Harris
Tryptophan hydroxylase gene variant and smoking behavior.
色氨酸羟化酶基因变异与吸烟行为。
- DOI:
- 发表时间:
2001 - 期刊:
- 影响因子:0
- 作者:
C. Lerman;C. Lerman;Neil E. Caporaso;A. Bush;Yun;J. Audrain;D. Main;Peter G. Shields - 通讯作者:
Peter G. Shields
Lack of association of tyrosine hydroxylase genetic polymorphism with cigarette smoking.
酪氨酸羟化酶遗传多态性与吸烟缺乏关联。
- DOI:
10.1097/00008571-199712000-00012 - 发表时间:
1997 - 期刊:
- 影响因子:0
- 作者:
C. Lerman;Peter G. Shields;D. Main;J. Audrain;Joan Roth;Neil R. Boyd;Neil E. Caporaso - 通讯作者:
Neil E. Caporaso
Peter G. Shields的其他文献
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{{ truncateString('Peter G. Shields', 18)}}的其他基金
Project 1: Urban and Rural Male Youth Cohort Study of Tobacco Use
项目1:城乡男性青少年烟草使用队列研究
- 批准号:
9333246 - 财政年份:2017
- 资助金额:
$ 399.25万 - 项目类别:
The Effects of a Standardized Research E-Cigarette On The Human Lung: A Clinical Trial With Bronchoscopic Biomarkers
标准化研究电子烟对人肺的影响:支气管镜生物标志物的临床试验
- 批准号:
9476111 - 财政年份:2017
- 资助金额:
$ 399.25万 - 项目类别:
Project 2: Understanding Adolescent Trajectories, Exposures and Suscep
项目 2:了解青少年轨迹、暴露和 Suscep
- 批准号:
9333247 - 财政年份:2017
- 资助金额:
$ 399.25万 - 项目类别:
Project 4: Comprehension of Health Risks in More and Less Arousing Affe
项目四:在或多或少引发的情感中理解健康风险
- 批准号:
9333249 - 财政年份:2017
- 资助金额:
$ 399.25万 - 项目类别:
Project 1: Urban and Rural Male Youth Cohort Study of Tobacco Use p138-171
项目1:城乡男性青少年烟草使用队列研究 p138-171
- 批准号:
8595671 - 财政年份:2013
- 资助金额:
$ 399.25万 - 项目类别:
Core E: Research Training and Education Core p378-391
核心 E:研究培训和教育核心 p378-391
- 批准号:
8595692 - 财政年份:2013
- 资助金额:
$ 399.25万 - 项目类别:
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