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（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