Clinical Pharmacology of Electronic Cigarettes

电子烟的临床药理学

• 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
• 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

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.

项目摘要/摘要 该提案是对我们研究的竞争续订申请的重新提交的“临床药理学 电子烟”。FDA认为电子烟（EC）为烟草产品 根据2009年的《预防家庭吸烟和烟草控制法》受到监管。在 与FDA监管相关的特征是EC的加性和潜在危害，这两者都 通过尼古丁的影响确定在基本上确定。 EC的法规可能包括对设备的调节 电源，线圈和灯芯的性质以及EC液体的组成。一个关键的未解决的监管问题是 是否应限制电子液体的尼古丁含量。 基于EC用户中尼古丁滴定的证据，我们质疑为设定上限的提议 电子液体的尼古丁含量将使转向EC的吸烟者的健康受益，以帮助安静的香烟 吸烟。我们假设相反 - 即EC用户将滴定尼古丁的摄入量，以便他们 将吸入类似数量的尼古丁，但使用较高的气溶胶有毒物质，对健康造成的损害较小 与较低的尼古丁含量电子液体。这，我们建议研究系统性的尼古丁暴露；尼古丁有关 主观，心血管（CV）和荷尔蒙作用；暴露于非纽约定有毒物质（挥发性有机物） 化合物，例如丙烯醛和苯）； EC用户中CV疾病（CVD）风险的生物标志物和生物标志物转换 从低到高尼古丁含量电子液体。如果我们使用高尼古丁的假设是较低的潜在风险 确认集中EC，这表明联邦法规不是对尼古丁的上限 内容，在某些情况下，调节器可能会促进使用更高而不是较低的尼古丁液体 安全的原因。