Clinical Pharmacology of Electronic Cigarettes

电子烟的临床药理学

基本信息

批准号：
9978768
负责人：
NEAL L BENOWITZ
金额：
$ 75.22万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-06-01 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9978768
关键词：
Acrolein Acrylonitrile Address Adopted Adult Aerosols Benzene Biological Markers Blood Pressure Cardiovascular system Catecholamines Characteristics Clinical Pharmacology Devices Electronic cigarette European Union Excretory function Exposure to Family Smoking Prevention and Tobacco Control Act Generations Harm Reduction Health Health Benefit Heart Rate Hormonal Inflammation Inhalation Intake JUUL Kinetics Liquid substance Nature Nicotine Participant Plasma Platelet Activation Regulation Rewards Risk Safety Sensory Smoker Sodium Chloride Standardization Testing Thrombosis Time Titrations Withdrawal Symptom absorption authority base cardiovascular disorder risk cigarette smoking circadian electronic cigarette use electronic cigarette user electronic liquid electronic vape endothelial dysfunction liquid nicotine nicotine exposure novel oxidant stress propylene oxide psychologic risk perception satisfaction tobacco products toxicant urinary volatile organic compound

项目摘要

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.

项目概要/摘要该提案是我们研究的竞争性更新申请的重新提交，“Clinical Pharmacology of FDA 已将电子烟 (EC) 视为烟草产品。 2009 年《家庭吸烟预防和烟草控制法》对此进行了监管。与 FDA 监管相关的特征是 EC 的成瘾性和潜在危害，这两点很大程度上取决于尼古丁的影响，EC 的法规可能包括对设备的法规。功率、线圈和吸芯的性质以及 EC 液体的成分是一个尚未解决的关键监管问题。是否应限制电子烟油的尼古丁含量。根据电子烟使用者尼古丁滴定的证据，我们质疑设定上限的主张电子烟油中的尼古丁含量将有益于改用 EC 来帮助戒烟的吸烟者的健康我们采取了相反的做法——即电子烟使用者会逐渐调整尼古丁的摄入量，这样他们就可以减少尼古丁的摄入量。使用较高剂量时，会吸入相似量的尼古丁，但气溶胶毒物较少，对健康造成的伤害也较小与尼古丁含量较低的电子烟油相比，我们建议研究与尼古丁相关的全身暴露；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）化合物，如丙烯醛和苯）；以及 EC 使用者的心血管疾病 (CVD) 风险生物标志物发生了变化从低到高尼古丁含量的电子液体如果我们假设使用高尼古丁的潜在风险较低。浓度 EC 得到确认，这表明联邦法规不对尼古丁设定上限含量，并且监管机构在某些情况下可能会提倡使用较高而不是较低的尼古丁液体安全原因。