Division of Environmental Health Sciences, College of Public Health, The Ohio State University, Columbus, Ohio, United States of America.
Center for Tobacco Research, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States of America.
PLoS One. 2023 Sep 21;18(9):e0291786. doi: 10.1371/journal.pone.0291786. eCollection 2023.
Electronic cigarette (EC) use has increased rapidly in the last decade, especially among youth. Regulating nicotine delivery from ECs could help curb youth uptake and leverage EC use in harm reduction yet is complicated by varying device and liquid variables that affect nicotine delivery. Nicotine flux, the nicotine emission rate, is a parameter that incorporates these variables and focuses on the performance rather than the design of an EC. Nicotine flux therefore could be a powerful regulatory tool if it is shown empirically to predict nicotine delivery and subjective effects related to dependence.
This project consists of two complementary clinical trials. In Trial I, we will examine the relationship between nicotine flux and the rate and dose of nicotine delivery from ECs, hence, impacting abuse liability. It will also examine the extent to which this relationship is mediated by nicotine form (i.e., freebase versus protonated). At Yale School of Medicine (YSM), study participants will puff EC devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. In Trial II, we will assess the relationship between nicotine flux, form, and subjective effects. At the American University of Beirut (AUB), participants will use EC devices with varying nicotine fluxes and forms, while dependency measures, such as the urge to use ECs, nicotine craving, and withdrawal symptoms, will be assessed. We will also monitor puffing intensity and real-time exposure to toxicants.
The protocol of Trial I and Trial II was approved by YSM and AUB IRBs, respectively. We will disseminate study results through peer-reviewed publications and conference presentations.
NCT05706701 for Trial I and NCT05430334 for Trial II.
在过去的十年中，电子烟（EC）的使用迅速增加，尤其是在年轻人中。调节 EC 中的尼古丁输送量可能有助于遏制年轻人的使用，并利用 EC 减少危害，但这受到影响尼古丁输送量的各种设备和液体变量的影响而变得复杂。尼古丁流量是一个参数，它综合了这些变量，侧重于性能而不是 EC 的设计。如果尼古丁流量能够通过经验证明可以预测与依赖相关的尼古丁输送和主观影响，那么它可能成为一个强大的监管工具。
该项目由两项互补的临床试验组成。在试验 I 中，我们将研究尼古丁流量与 EC 中尼古丁输送的速度和剂量之间的关系，从而影响滥用倾向。它还将研究这种关系在多大程度上受到尼古丁形式（即游离碱与质子化）的影响。在耶鲁大学医学院（YSM），研究参与者将在不同流量和形式的条件下抽吸 EC 设备，同时以高时间分辨率采集动脉血液样本。在试验 II 中，我们将评估尼古丁流量、形式和主观影响之间的关系。在贝鲁特美国大学（AUB），参与者将使用具有不同尼古丁流量和形式的 EC 设备，同时评估依赖性测量，如使用 EC 的欲望、尼古丁渴求感和戒断症状。我们还将监测抽吸强度和实时暴露于有毒物质。
试验 I 和试验 II 的方案分别获得了 YSM 和 AUBIRB 的批准。我们将通过同行评审的出版物和会议报告来传播研究结果。
试验 I 为 NCT05706701，试验 II 为 NCT05430334。
