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Compensatory Behavior of E-cig Users in response to Reduced Nicotine E-liquids

电子烟用户对低尼古丁电子烟油的补偿行为

基本信息

批准号：
10171836
负责人：
Risa Jean Robinson
金额：
$ 18.31万
依托单位：
ROCHESTER INSTITUTE OF TECHNOLOGY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-01 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10171836
关键词：
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol Adult Aerosols Affect Age Area Behavior Characteristics Consumption Cotinine Cross-Over Studies Crossover Design Development Dose Environment Equilibrium Exhalation Exhibits Exposure to Financial compensation Gases Gender Goals Individual Inhalation Intention Intervention Knowledge Lung Measures Methods Modeling Monitor National Institute of Drug Abuse Nicotine Nicotine Dependence Outcome Outcome Measure Participant Particulate Matter Pattern Population Proxy Questionnaires Randomized Regulation Research Research Design Research Personnel Respiration Risk Assessment Saliva Salivary Sampling Surface Testing Time Toxin Urine Withdrawal Withdrawal Symptom arm base craving e-cigarette cessation electronic cigarette use electronic cigarette user electronic liquid exhaustion interest negative emotional state nicotine exposure novel preference psychosocial recruit respiratory response sex tobacco products tobacco regulation uptake vape pens vaping wearable sensor technology

项目摘要

Project Summary/Abstract Impact: This research explores the premise that e-cig users are able to compensate for lower nicotine products by adapting their behavior to maintain their desired nicotine level. When presented with a lower nicotine product, nicotine addicted e-cig users may alter their puffing topography to generate a more highly dense aerosol, and thus increase their consumption of total particulate matter in order to achieve their dose of nicotine. In addition, users may alter their respiratory parameters such as increasing inhalation volume, pulling the aerosol deeper into the lung and increasing the surface area available for gas exchange, or holding the aerosol in their lungs for a longer period of time, allowing for more nicotine uptake before exhaling. All of these changes in behavior are considered compensation, and may result in increased exposure to total particulate matter and ultimately increase the harm potential of what would otherwise be consider a reduced harm product. Study Design: The project involves a 17-day natural environment study with a two arm, two period cross-over design. N=80 current established adult vape pen users, currently using eliquids with nicotine strengths greater than or equal to 13 mg/mL, with no intention to quit e-cig use, and no use of combustible or other tobacco products will be randomized by age, gender, usual brand nicotine strength, and nicotine dependence score into control (non-switching) and test (switching) arms. The test arm will be switched to a lower nicotine strength eliquid (6 mg/mL) matching their usual flavor, while the control arm will continue to use their usual nicotine strength. The RIT wPUMTM vape pen monitor will record puff topography (puff volume, flow rate, duration, interpuff interval) and the Hexoskin wearable sensorized garment will record respiratory parameters (inhalation/exhalation volume and time, breath hold) for every puff taken while vaping ad-lib in their natural environment. Participants will provide salivary cotinine samples and complete a daily log of product use, compliance and subjective effects including craving, withdrawal symptoms and positive/negative emotional state on users’ ability to compensate for low nicotine eliquids. Specific Aims: The objective of Aim 1 is to quantify changes in topography, respiration and TPM exposure upon switching from their usual to a lower nicotine strength eliquid. The objective of Aim 2 is to assess the extent to which users are able to compensate their behavior using salivary cotinine levels before and after the switch as a proxy for compensation efficacy. We will test two hypotheses; (H1) exposure to TPM will increase upon switching to a reduced nicotine eliquid and (H2) salivary cotinine levels will remain unchanged. We will investigate the presence of random subjective effects, and age/gender on compensation using a generalized linear mixed-effects model. Regulation: Knowledge gained informs regulations related to limiting nicotine in eliquids. Exposure to both nicotine and total particulate matter are important in risk assessment, and the potential to inadvertently increase one by decreasing the other must be considered in product regulation.

项目概要/摘要影响：这项研究探讨了电子烟用户能够补偿尼古丁含量较低的前提通过调整他们的行为来维持他们所需的尼古丁水平。当呈现较低的尼古丁产品，尼古丁成瘾的电子烟用户可能会改变他们的抽吸地形以产生更高的烟度。浓密的气溶胶，从而增加其总颗粒物的消耗，以达到其剂量尼古丁。此外，用户可以改变他们的呼吸参数，例如增加吸气量、拉气气溶胶深入肺部并增加可用于气体交换的表面积，或保持气溶胶在肺部停留的时间较长，从而在呼气前吸收更多的尼古丁。所有这些行为的改变被认为是补偿，并可能导致接触总颗粒物的增加问题并最终增加原本被认为减少伤害的潜在伤害产品。研究设计：该项目涉及为期17天的自然环境研究，分两臂、两期交叉设计。 N=80 名目前已建立的成人电子烟笔使用者，目前使用含有尼古丁的电子烟浓度大于或等于 13 mg/mL，无意停止使用电子烟，并且不使用可燃或其他烟草产品将按年龄、性别、常用品牌尼古丁浓度和尼古丁进行随机分组控制组（非转换组）和测试组（转换组）的依赖性得分。测试臂将切换到较低尼古丁浓度的液体（6 毫克/毫升）与其通常的口味相匹配，而控制臂将继续使用他们通常的尼古丁强度。 RIT wPUMTM 电子烟笔监视器将记录抽吸形态（抽吸量、流量频率、持续时间、吸气间隔），Hexoskin 可穿戴传感服装将记录呼吸随意抽吸时每次抽吸的参数（吸气/呼气量和时间、屏气）自然环境。参与者将提供唾液可替宁样本并完成每日产品日志使用、依从性和主观影响，包括渴望、戒断症状和积极/消极情绪状态对使用者补偿低尼古丁液体能力的影响。具体目标：目标 1 的目标是量化地形、呼吸和 TPM 暴露从平常切换到较低水平时的变化尼古丁强度液体。目标 2 的目标是评估用户能够补偿的程度他们的行为使用转换前后的唾液可替宁水平作为补偿功效的代表。我们将检验两个假设； (H1) 改用低尼古丁烟油后，接触 TPM 的机会将会增加 (H2) 唾液可替宁水平将保持不变。我们将调查随机主观因素的存在使用广义线性混合效应模型分析年龄/性别对薪酬的影响。规定：获得的知识为与限制液体中尼古丁相关的法规提供了信息。接触尼古丁和总颗粒物在风险评估中很重要，并且有可能无意中增加一产品监管中必须考虑减少其他因素。