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

• 批准号: 10678555
• 负责人: Hongying Daisy Dai
• 金额: $ 20.84万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10678555
• 关键词: 18 year old; 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Abstinence; Address; Adult; Authorization documentation; Behavior; Biological Markers; Carcinogens; Characteristics; Cigarette; Cigarette Smoker; Cotinine; Creatinine; Data; Dependence; Devices; Dose; Electronic Nicotine Delivery Systems; Electronic cigarette; Electronics; Exposure to; Formulation; Frequencies; Future; Goals; Grant; Harm Reduction; Health; Inhalation; Interview; JUUL; Knowledge; Link; Logic; Lung; Marketing; Measures; Metals; Modeling; Modernization; Nicotine; Nicotine Dependence; Outcome; Oxidative Stress; Persons; Play; Population; Population Assessment of Tobacco and Health; Population Study; Public Health; Relapse; Reporting; Research; Role; Serum; Smoker; Sodium Chloride; Surveys; Testing; Tobacco; Tobacco use; United States Food and Drug Administration; Urine; authority; biomarker selection; cigarette smoking; cigarette user; combustible cigarette; electronic liquid; former smoker; innovation; liquid nicotine; never smoker; nicotine exposure; nicotine use; pod mods; population health; prospective; smoking cessation; smoking relapse; tobacco advertising; tobacco exposure; tobacco products; tobacco regulatory science; toxicant; two-dimensional; uptake; vaper; vaping

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（末端或电子烟）是一类新的烟草产品，可能代表 减少了混合吸烟者的伤害替代品。 2020年，18岁的成年人中有3.7％（920万） 较旧的报道目前使用了目的。当前的每天或一天的使用最普遍 目前的吸烟者（13.8％）和以前的吸烟者（13.3％），在成人永不吸烟者中并不常见 （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的决定剂之一 和感觉运动特征，并且末端有多种尼古丁浓度水平。 现代蒸发产品（例如Juul（例如Juul））在盐配方中包含尼古丁，并且倾向于 更有效地将尼古丁输送到肺部。最近，食品药品监督管理局（FDA）已授予 在前市场烟草产品营销审查中，有几个产品的结局，尼古丁水平有不同 AS 0％（Logic Pro），1.5％（Vuse Ciro），3.0％（Vuse Viper），4.5％（Njoy Daily Rich）和6.0％（Njoy Daily Extra Extra 富有的）。同时，FDA宣布了拟议规则的计划，以将尼古丁水平降低至最低限度上瘾或 香烟（CIG）中的非添加水平。关于电子液体尼古丁浓度水平的影响的研究， 尤其是不同的尼古丁水平与健康效应，烟草使用行为和尼古丁如何相关 依赖性以及尼古丁水平与人口水平上的烟式相互作用如何具有重要的 对未来烟草监管科学的影响。这项大规模的人口研究将与人口联系起来 评估烟草和健康（路径）波1-6限制生物标志物与路径成人访谈 调查。在AIM 1中，我们将分析合并的路径生物标志物与成人访谈数据1）检查 尼古丁浓度水平（例如，零，低，媒介 和高）和2）尼古丁水平和蒸气产品对5类FDA的BOE的测试相互作用影响 定义有害且潜在的有害构成（HPHC）：尼古丁代谢物，TSNA，金属，PAHS，VOC 使用加权多变量 回归模型。在AIM 2中，我们将利用统一的纵向浪潮1-6路径成人访谈数据 前瞻性检查末端中尼古丁水平的关联，并与烟草使用行为进行烟雾 （例如，随后从吸烟或随后戒烟的戒酒）和尼古丁 依赖。这项研究具有创新性，重点是电子液体尼古丁浓度水平和 关于人口健康（生物标志物），结束的vap vap an 利用全国纵向数据。这些信息对未来的烟草具有重要意义 人口层面的监管科学，可以指导FDA未来的烟草产品是否 应授权较高尼古丁产品的申请（PMTA）提交。 1