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

项目摘要/摘要 影响：这项研究探索了电子烟使用者能够补偿较低尼古丁的前提 通过调整他们的行为来保持他们想要的尼古丁水平。当出现较低的 尼古丁产品，尼古丁成瘾的电子烟使用者可能会改变他们的吸烟地形，以产生更高的 致密的气溶胶，从而增加他们对总颗粒物的消耗，以实现他们的剂量 尼古丁。此外，使用者可以改变他们的呼吸参数，如增加吸气量、拉动 气雾剂深入肺内，增加可用于气体交换的表面积，或保持 气雾剂在肺中停留的时间更长，在呼气之前允许更多的尼古丁摄取。所有这些都是 行为的改变被认为是补偿，并可能导致暴露在总颗粒物中的增加 物质，并最终增加本来被认为是减少的危害的潜在危害 产品。研究设计：该项目包括为期17天的自然环境研究，两个手臂，两个阶段 交叉设计。N=80名目前已建立的成人电子烟笔使用者，目前正在使用含有尼古丁的eLiquid 浓度大于或等于13毫克/毫升，无意停止使用电子烟，也不使用易燃或 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 依赖性得分分为控制(非转换)和测试(转换)臂。测试臂将切换为 尼古丁强度较低的液体(6毫克/毫升)与其平时的味道相匹配，而对照臂将继续使用 他们通常的尼古丁浓度。RIT wPUMTM VAPE PEN监视器将记录喷雾地形(喷雾体积、流量 速度、持续时间、间隔时间)和Hexoskin可穿戴的传感服装将记录呼吸 每吸一口气时的参数(吸气量/呼气量和呼气时间、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，包括渴求、戒断症状和阳性/阴性 情绪状态影响用户对低尼古丁eLiquid的补偿能力。具体目标：目标1的目标 是量化地形、呼吸和TPM暴露从平时到较低水平时的变化 尼古丁浓缩液。目标2的目标是评估用户能够补偿的程度 他们的行为使用唾液可替宁水平在转换前后作为补偿效果的替代指标。 我们将检验两个假设；(H1)改用减少的尼古丁液体后，接触TPM的机会增加 和(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对薪酬的影响、年龄/性别进行了分析。法规： 所获得的知识为限制eLiquid中尼古丁的相关法规提供了信息。同时接触尼古丁和 总颗粒物在风险评估中很重要，无意中增加一个颗粒物的可能性 在产品监管中必须考虑减少另一种。

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.