Clinical Pharmacology of Electronic Cigarettes

项目摘要/摘要 该提案是对我们研究的竞争性续订申请的重新提交，《临床药理学 电子烟“。FDA已将电子烟(EC)视为烟草产品，将 2009年《家庭吸烟预防和烟草控制法》对此进行了规范。在这些人中 与FDA监管相关的特征是ECs的成瘾性和潜在危害，这两者都 在很大程度上由尼古丁的影响决定。对ECS的监管可以包括对设备的监管 功率、线圈和灯芯的性质，以及EC液体的组成。一个关键的尚未解决的监管问题是 是否应该对电子液体的尼古丁含量进行限制。 基于EC使用者尼古丁滴定的证据，我们质疑设定上限的命题 电子烟液中的尼古丁含量将有利于改用EC戒烟的吸烟者的健康 抽烟。我们的假设正好相反--即EC使用者会滴定他们的尼古丁摄入量，从而使他们 会吸入相同数量的尼古丁，但气雾剂有毒物质较少，对健康的损害较小 与尼古丁含量较低的电子液体相比。因此，我们建议研究全身尼古丁暴露；尼古丁相关 主观、心血管(CV)和激素影响；接触非尼古丁毒物(挥发性有机物质 化合物，如丙烯醛和苯)；以及改变EC使用者心血管疾病(CVD)风险的生物标志物 从低尼古丁含量到高尼古丁含量的电子液体。如果我们关于使用高尼古丁的潜在风险较低的假设 浓度ECS得到确认，这将表明联邦法规不会对尼古丁设定上限 在某些情况下，监管机构可能会提倡使用较高尼古丁液体而不是较低尼古丁液体 安全原因。

PROJECT SUMMARY/ABSTRACT This proposal is a resubmission of a competing renewal application for our study, “Clinical Pharmacology of Electronic Cigarettes”. The FDA has deemed electronic cigarettes (EC) to be tobacco products that are to be regulated as such under the 2009 Family Smoking Prevention and Tobacco Control Act. Among the characteristics that are relevant to FDA regulation are the addictiveness and potential harm of ECs, both of which are determined in substantially by effects of nicotine. Regulations of ECs could include regulation of the device power, nature of coils and wicks, and the composition of EC liquids. A critical unresolved regulatory issue is whether there should be limit on the nicotine content of e-liquids. Based on evidence of nicotine titration in EC users, we question the proposition that setting an upper limit for nicotine content of e-liquids will benefit the health of smokers who are switching to EC to aid quitting cigarette smoking. We hypothesize the opposite – namely that EC users will titrate their intake of nicotine such that they will inhale similar amount of nicotine but fewer aerosol toxicants and suffer less harm to health when using higher vs lower nicotine content e-liquids. Thus, we propose to study systemic nicotine exposure; nicotine-related subjective, cardiovascular (CV) and hormonal effects; exposure to non-nicotine toxicants (volatile organic compounds, such as acrolein and benzene); and biomarkers of CV disease (CVD) risk in EC users switched from low to high nicotine content e-liquids. If our hypothesis of lower potential risk with use of high nicotine concentration ECs is confirmed, it would suggest that federal regulation not place an upper limit on nicotine content, and that regulators might in some cases promote the use of higher rather than lower nicotine liquids for reasons of safety.