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

项目概要 电子尼古丁输送系统（ENDS，或电子烟）是一种新型烟草产品，可能代表 2020 年，3.7%（920 万）的 18 岁成年人会选择吸烟者减少伤害。 目前每天或某天使用 ENDS 的情况最为普遍。 当前吸烟者（13.8%）和曾经吸烟者（13.3%），并且在成年从不吸烟者中并不常见 (2.2%) 电子烟液尼古丁浓度水平是尼古丁释放量的主要产品水平决定因素之一。 和感觉运动特征，并且 ENDS 中有多种尼古丁浓度水平。 现代电子烟产品（例如像 JUUL 这样的 pod-mod 风格）的盐配方中含有尼古丁，并且往往会 最近，美国食品和药物管理局 (FDA) 已批准将尼古丁更有效地输送到肺部。 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含量，例如 为 0% (Logic Pro)、1.5% (Vuse Ciro)、3.0% (Vuse Viper)、4.5% (NJOY Daily Rich) 和 6.0% (NJOY Daily Extra) 与此同时，FDA 宣布了拟定规则的计划，以将尼古丁含量降低到最低限度或成瘾性。 香烟（Cig）中的非成瘾水平对电子液体尼古丁浓度水平影响的研究， 尤其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 依赖以及尼古丁水平如何与人口层面的电子烟设备相互作用，可能具有重要意义 对未来烟草监管科学的影响。这项大规模人口研究将把人口联系起来。 通过 PATH 成人访谈评估烟草与健康 (PATH) 第 1-6 波限制性生物标志物 在目标 1 中，我们将分析汇总的 PATH 生物标志物-成人访谈数据，以 1) 检查- 受试者的暴露生物标志物 (BOE) 因尼古丁浓度水平（例如零、低、中）而存在差异 2) 测试尼古丁水平和电子烟产品对 FDA 5 类 BOE 的相互作用影响 确定的有害和潜在有害成分 (HPHC)：尼古丁代谢物、TSNA、金属、PAH、VOC 以及使用加权多变量对尿液和血清组中的健康影响（例如氧化应激）的 BOE 在目标 2 中，我们将利用统一的纵波 1-6 PATH 成人访谈数据。 前瞻性研究 ENDS 和电子烟设备中的尼古丁水平与烟草使用行为的关联 （例如，随后戒烟或随后复发吸烟）和尼古丁 这项研究的创新之处在于它关注电子烟油尼古丁浓度水平和依赖性的影响。 电子烟设备对人口健康（生物标志物）的影响，ENDS ↔ 香烟使用转变和尼古丁依赖 利用全国纵向数据对未来的烟草具有重要影响。 人口层面的监管科学，可以指导 FDA 未来是否上市前烟草产品 高尼古丁产品的申请（PMTA）提交应获得授权。 1

项目成果

Association of Race-Ethnicity Intersection with Disparities in Cigarette Smoking in US Adults.

种族与民族交叉与美国成年人吸烟差异的关联。

• 发表时间: 2024-02-24
• 作者: Dai, Hongying Daisy;Subica, Andrew;Mattingly, Delvon T;Harlow, Alyssa;Leventhal, Adam M
• 通讯作者: Leventhal, Adam M