Does Switching to Nicotine-containing Electronic Cigarettes Reduce Health Risk Markers?

改用含尼古丁的电子烟会减少健康风险标志吗？

• 批准号: 9752508
• 负责人: JONATHAN FOULDS
• 金额: $ 76.06万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9752508
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Adult; Awareness; Behavioral; Biological Markers; Blood; Carcinogens; Cardiovascular system; Cigarette; Cigarette Smoker; Cotinine; Databases; Dependence; Development; Devices; Dose; Double-Blind Method; Electrocardiogram; Electronic cigarette; Exhalation; Free Radicals; Funding; Glutathione; Goals; Health; Human; Infrastructure; Lipids; Liquid substance; Lung; Measures; Nicotine; Outcome; Oxides; Participant; Placebos; Process; Propylene Glycols; Pulmonary function tests; Randomized; Research; Respiratory System; Risk; Risk Marker; Role; Science; Smoker; Smoking; Smoking Behavior; Smoking and Health Research; Solvents; Source; Standardization; Surveys; Telephone; Testing; Tobacco; Tobacco use; United States; United States National Institutes of Health; Work; behavior change; cancer biomarkers; cardiovascular effects; cardiovascular risk factor; cigarette smoking; cohort; combustible cigarette; design; electronic cigarette use; fine particles; follow-up; former smoker; innovation; liquid nicotine; nicotine inhalation; nicotine vapor; placebo controlled study; recruit; respiratory; smoking cessation; vegetable glycerin; volunteer

Project Summary/Abstract Over the past ten years, a new inhaled nicotine device, popularly referred to as an electronic cigarette (e-cig), has become increasingly popular around the world, particularly in the United States where more than 79% of US adults are currently aware of the devices and 3.7% are using one on a regular basis. Current e-cig use is most prevalent among current smokers (15.9%) and recent ex-smokers (22.0%) and is very uncommon among adult never cigarette smokers (0.4%). As the popularity of these devices has increased, the types of devices and the associated products available to users have diversified, making it difficult for users and non-users alike to understand the devices and their potential harms or benefits. E-cigarettes deliver high doses of fine particles and highly oxidizing free radicals in the human respiratory system. Fine particles are emitted when the solvents propylene glycol and vegetable glycerin, along with flavors, additives and nicotine are aerosolized, and respiratory and cardiovascular effects have been documented, but adequate assessments are lacking. The recent development of a Standardized Research E-Cig (SREC) with both medium (15 mg/ml) and placebo (zero mg/ml) nicotine concentration in the liquid now offers the possibility of testing the likely health effects of attempting to switch from cigarette smoking to an SREC and to examine the effects of nicotine in the liquid on that process. Our long term goal is to understand the likely health effects of cigarette smokers switching to a Standardized Research E-Cig (SREC) and to assess the role of nicotine delivery on switching, acceptability and markers of health outcomes. The specific objective of this proposal is to recruit a cohort of 240 current exclusive daily smokers and to measure a comprehensive battery of health markers at baseline and at 3 and 6 weeks after attempting to switch completely to SRECs containing either zero or 15 mg/ml nicotine in a randomized double-blind, placebo-controlled design. The NIH-funded Penn State Tobacco Center of Regulatory Science has conducted a number of preliminary studies of electronic cigarette use. These studies have provided us with the infrastructure and expertise to conduct a study of health risks associated with switching to a Standardized Research E-Cig, with the following three specific aims: AIM 1. To characterize the short-term effects of attempting to switch from traditional cigarette smoking to a Standardized Research E-Cig using a comprehensive battery of measures (e.g. carcinogen biomarker, NNAL, pulmonary function testing, lipid panel, glutathione, exhaled CO, blood nicotine and cotinine, BP etc.) over 6 weeks. AIM 2. To compare the effects of nicotine containing versus zero nicotine liquid on reduction of smoking behavior and health markers. AIM 3. At the end of each participant's 6 week participation they will be provided with information about the health effects of tobacco product use, how to purchase SREC supplies if they wish to continue using and sources of assistance to quit smoking, and they will be asked to complete telephone and online survey 4 weeks later.

项目总结/摘要 在过去的十年里，一种新的吸入尼古丁的装置，通常被称为电子烟（e-cig）， 在世界各地越来越受欢迎，特别是在美国，超过79%的 美国成年人目前知道这些设备，3.7%的人定期使用。目前电子烟的使用是 在当前吸烟者（15.9%）和近期戒烟者（22.0%）中最常见， 从不吸烟的成年人（0.4%）。随着这些设备的普及，设备的类型 用户可获得的相关产品已经多样化，使得用户和非用户都难以 了解器械及其潜在危害或受益。电子烟提供高剂量的细颗粒 以及人体呼吸系统中的高氧化性自由基。当溶剂中含有 丙二醇和植物甘油，沿着香料、添加剂和尼古丁被雾化， 对呼吸和心血管的影响已有记录，但缺乏充分的评估。的 最近开发了一种标准化研究电子烟（SREC），含培养基（15 mg/ml）和安慰剂 (zero现在，液体中的尼古丁浓度（mg/ml）提供了测试尼古丁对健康可能影响的可能性。 试图从吸烟转换到SREC，并检查液体中尼古丁对 这个过程。我们的长期目标是了解吸烟者转向吸烟对健康的可能影响。 标准化研究电子烟（SREC），并评估尼古丁输送对转换、可接受性 和健康结果的标志物。这项建议的具体目标是招募一批240名目前 在基线和第3和第6天测量一组全面的健康标志物 在尝试完全转换为含有零或15 mg/ml尼古丁的SREC后的几周内， 随机双盲、安慰剂对照设计。美国国立卫生研究院资助的宾夕法尼亚州立烟草中心 Regulatory Science对电子烟的使用进行了一些初步研究。这些研究 为我们提供了基础设施和专业知识，以进行与健康风险相关的研究， 切换到标准化研究电子烟，有以下三个具体目标：目的1。表征 尝试从传统吸烟转向标准化研究电子烟的短期影响 使用一套全面的测量方法（例如致癌物生物标志物，NNAL，肺功能测试， 血脂、谷胱甘肽、呼出CO、血尼古丁和可替宁、BP等）超过6周。AIM 2.比较 含尼古丁液体与不含尼古丁液体对减少吸烟行为和健康的影响 标记。AIM 3.在每个参与者的6周参与结束时，他们将获得信息 关于烟草产品使用对健康的影响，如果他们希望继续使用，如何购买SREC用品 及协助戒烟的途径，并要求他们完成电话及网上调查4 周后