Effects of Nicotine Concentration Levels in E-cigarettes on Biomarkers of Exposure to Toxicants and Tobacco Use Behaviors
电子烟中尼古丁浓度水平对有毒物质暴露和烟草使用行为生物标志物的影响
基本信息
- 批准号:10678555
- 负责人:
- 金额:$ 20.84万
- 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:2023-09-01 至 2025-08-31
- 项目状态:未结题
- 来源:
- 关键词:18 year old4-(methylnitrosamino)-1-(3-pyridyl)-1-butanolAbstinenceAddressAdultAuthorization documentationBehaviorBiological MarkersCarcinogensCharacteristicsCigaretteCigarette SmokerCotinineCreatinineDataDependenceDevicesDoseElectronic Nicotine Delivery SystemsElectronic cigaretteElectronicsExposure toFormulationFrequenciesFutureGoalsGrantHarm ReductionHealthInhalationInterviewJUULKnowledgeLinkLogicLungMarketingMeasuresMetalsModelingModernizationNicotineNicotine DependenceOutcomeOxidative StressPersonsPlayPopulationPopulation Assessment of Tobacco and HealthPopulation StudyPublic HealthRelapseReportingResearchRoleSerumSmokerSodium ChlorideSurveysTestingTobaccoTobacco useUnited States Food and Drug AdministrationUrineauthoritybiomarker selectioncigarette smokingcigarette usercombustible cigaretteelectronic liquidformer smokerinnovationliquid nicotinenever smokernicotine exposurenicotine usepod modspopulation healthprospectivesmoking cessationsmoking relapsetobacco advertisingtobacco exposuretobacco productstobacco regulatory sciencetoxicanttwo-dimensionaluptakevapervaping
项目摘要
Project Summary
Electronic Nicotine Delivery System (ENDS, or e-cigarette) is a new class of tobacco products and may represent
a reduced harm alternative for combustible cigarette smokers. In 2020, 3.7% (9.2 million) of adults aged 18 years
and older reported current use of ENDS. Current everyday or some-day ENDS use is most prevalent among
current cigarette smokers (13.8%) and former smokers (13.3%) and is uncommon among adult never smokers
(2.2%). E-liquid nicotine concentration level is one of the primary product-level determinants of nicotine delivery
and sensorimotor characteristics and there is a variety of nicotine concentration levels available in ENDS.
Modern vaping products (e.g., pod-mod style like JUUL) contain nicotine in the salt formulation and tend to
deliver nicotine to the lung more efficiently. Most recently, the Food and Drug Administration (FDA) has granted
several ENDS products in the Premarket Tobacco Product Marketing review with varying nicotine levels, such
as 0% (Logic Pro), 1.5% (Vuse Ciro), 3.0% (Vuse Viper), 4.5% (NJOY Daily Rich), and 6.0% (NJOY Daily Extra
Rich). Meanwhile, FDA announced plans for proposed rules to reduce nicotine levels to minimally addictive or
non-addictive levels among cigarettes (Cig). The research on the effects of e-liquid nicotine concentration levels,
especially how different nicotine levels are related to health effects, tobacco use behaviors, and nicotine
dependence and how nicotine levels interplay with vaping devices at the population level, can have important
implications for future tobacco regulatory sciences. This large-scale population study will link the Population
Assessment of Tobacco and Health (PATH) Waves 1-6 restricted biomarker with the PATH Adult Interview
surveys. In Aim 1, we will analyze the pooled PATH biomarker-adult interview data to 1) examine between-
subjects differences in biomarkers of exposure (BOEs) by nicotine concentration levels (e.g., zero, low, medium
and high), and 2) test interaction effects of nicotine levels and vaping products on BOEs from 5 classes of FDA
defined harmful and potentially harmful constituents (HPHC): nicotine metabolites, TSNAs, metals, PAHs, VOCs
and the BOE of health effects (e.g., oxidative stress) in urine and serum panels using weighted multivariable
regression models. In Aim 2, we will leverage the harmonized longitudinal Waves 1-6 PATH Adult Interview data
to prospectively examine associations of nicotine levels in ENDS and vaping devices with tobacco use behaviors
(e.g., subsequent abstinence from cigarette smoking or subsequent relapse to cigarette smoking) and nicotine
dependence. This study is innovative in its focus on the effects of e-liquid nicotine concentration levels and
vaping devices on population health (biomarkers), ENDS ↔ Cig use transitions and nicotine dependence by
leveraging the nationally longitudinal data. Such information has important implications for future tobacco
regulatory sciences at the population level and can guide FDA as to whether future Premarket Tobacco Product
Application (PMTA) submissions for higher nicotine products should be authorized.
1
项目摘要
电子尼古丁输送系统(ENDS或电子烟)是一类新的烟草产品,可能代表
一种减少危害的替代品,用于可燃香烟吸烟者。2020年,3.7%(920万)的18岁成年人
和较老的报告目前使用的ENDS。目前每天或某一天使用的ENDS是最普遍的,
目前吸烟者(13.8%)和既往吸烟者(13.3%),在从不吸烟的成年人中不常见
(2.2%).电子液体尼古丁浓度水平是尼古丁递送的主要产品水平决定因素之一
和感觉运动特征,并且在ENDS中存在多种尼古丁浓度水平。
现代电子烟产品(例如,pod-mod风格,如JUUL)在盐制剂中含有尼古丁,
更有效地将尼古丁输送到肺部。最近,食品和药物管理局(FDA)已批准
上市前烟草产品营销审查中的几种ENDS产品具有不同的尼古丁水平,
0%(Logic Pro)、1.5%(Vuse Ciro)、3.0%(Vuse Viper)、4.5%(NJOY Daily Rich)和6.0%(NJOY Daily Extra
Rich)。与此同时,FDA宣布计划制定拟议的规则,以将尼古丁水平降低到最低程度,
香烟(Cig)中的非成瘾水平。电子烟液尼古丁浓度水平影响的研究,
特别是不同的尼古丁水平与健康影响、烟草使用行为和尼古丁之间的关系。
依赖性以及尼古丁水平如何与人口水平的电子烟设备相互作用,
对未来烟草监管科学的影响。这项大规模的人口研究将把人口
烟草与健康(PATH)Waves 1-6限制性生物标志物评估与PATH成人访谈
调查。在目标1中,我们将分析合并的PATH生物标志物-成人访谈数据,以1)检查-
受试者暴露生物标志物(BOE)的尼古丁浓度水平差异(例如,零、低、中
和高),以及2)测试尼古丁水平和电子烟产品对来自5类FDA标准的BOE的相互作用效应。
确定的有害和潜在有害成分(HPHC):尼古丁代谢物、TSNA、金属、PAH、VOC
以及健康影响的BOE(例如,氧化应激)在尿液和血清面板使用加权多变量
回归模型在目标2中,我们将利用协调纵向波1-6 PATH成人访谈数据
前瞻性地研究ENDS和电子烟装置中尼古丁水平与烟草使用行为的关系
(e.g.,随后戒烟或随后复吸香烟)和尼古丁
依赖这项研究是创新的,其重点是电子液体尼古丁浓度水平的影响,
vaping设备对人口健康(生物标志物),ENDS ParticipCig使用过渡和尼古丁依赖,
利用全国纵向数据。这些信息对未来的烟草业具有重要意义
在人群水平的监管科学,并可以指导FDA未来的上市前烟草产品
应授权提交高尼古丁产品的PMTA申请。
1
项目成果
期刊论文数量(1)
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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Hongying Daisy Dai其他文献
Biomarkers of secondhand smoke and vaping exposure among U.S. Adolescents
美国青少年二手烟和电子烟暴露的生物标志物
- DOI:
10.1016/j.addbeh.2025.108381 - 发表时间:
2025-10-01 - 期刊:
- 影响因子:3.600
- 作者:
Hongying Daisy Dai;Amber K Brown Keebler;Brian Young - 通讯作者:
Brian Young
Tobacco and Cannabis Co-Use by Sexual Minority Adults in the United States, 2022
2022年美国性少数群体成年人对烟草和大麻的共同使用情况
- DOI:
10.1016/j.amepre.2024.12.014 - 发表时间:
2025-04-01 - 期刊:
- 影响因子:4.500
- 作者:
Juhan Lee;Josephine T. Hinds;Hongying Daisy Dai;Andrea H. Weinberger - 通讯作者:
Andrea H. Weinberger
Historical trauma, substance use, and mental health symptoms among a sample of urban American Indians
美国城市印第安人样本中的历史创伤、药物滥用和心理健康症状
- DOI:
- 发表时间:
2022 - 期刊:
- 影响因子:0
- 作者:
Nicholas Guenzel;Hongying Daisy Dai;L. Dean - 通讯作者:
L. Dean
Prospective Associations of Exposure to Discrimination and Alcohol Use: A National Longitudinal Study
遭受歧视与饮酒之间的潜在关联:一项全国性纵向研究
- DOI:
10.1016/j.amepre.2024.12.005 - 发表时间:
2025-04-01 - 期刊:
- 影响因子:4.500
- 作者:
Nicholas Guenzel;Cheryl L. Beseler;Adam M. Leventhal;Junhan Cho;Hongying Daisy Dai - 通讯作者:
Hongying Daisy Dai
Perceived racism and discrimination and youth substance use in the United States – Intersections with sex and ethnicity
美国感知的种族主义,歧视和青年毒品的使用 - 与性别和种族的交集
- DOI:
10.1016/j.ypmed.2023.107811 - 发表时间:
2024-01-01 - 期刊:
- 影响因子:3.200
- 作者:
Hongying Daisy Dai;Grace Thiel;Dylan Hafer - 通讯作者:
Dylan Hafer
Hongying Daisy Dai的其他文献
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{{ truncateString('Hongying Daisy Dai', 18)}}的其他基金
Racial disparities for the effects of parental marijuana use on youth marijuana and other substance use
父母吸食大麻对青少年吸食大麻和其他药物的影响的种族差异
- 批准号:
10593655 - 财政年份:2023
- 资助金额:
$ 20.84万 - 项目类别:
Discrimination and Racial Inequalities in Drug Use in U.S. Adults: Associations and Mechanisms
美国成年人吸毒中的歧视和种族不平等:关联和机制
- 批准号:
10739180 - 财政年份:2023
- 资助金额:
$ 20.84万 - 项目类别:
Racial disparities in biomarkers, tobacco cessation, and smoking relapse in association with electronic cigarette use
与电子烟使用相关的生物标志物、戒烟和复吸的种族差异
- 批准号:
10395602 - 财政年份:2021
- 资助金额:
$ 20.84万 - 项目类别: