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.

项目摘要/摘要 在过去的十年里，一种新的尼古丁吸入设备，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%的人经常使用。目前电子烟的使用量为 在现在吸烟者(15.9%)和最近戒烟者(22.0%)中最常见，在 成人从不吸烟(0.4%)。随着这些设备的普及，设备的类型 而且用户可以使用的相关产品也变得多样化，这给用户和非用户带来了困难 了解这些设备及其潜在的危害或好处。电子烟会产生高剂量的细颗粒物 和人体呼吸系统中高度氧化的自由基。当溶剂释放出细小的颗粒时 丙二醇和蔬菜甘油以及香料、添加剂和尼古丁被雾化，以及 对呼吸和心血管的影响已有记录，但缺乏充分的评估。这个 含中浓度(15 mg/ml)和安慰剂的标准化研究电子免疫球蛋白(SREC)的研究进展 (0毫克/毫升)液体中的尼古丁浓度现在提供了测试可能的健康影响的可能性 尝试从吸烟转向SREC，并检查液体中尼古丁对 这一过程。我们的长期目标是了解吸烟者改用 标准化研究E-Cig(SREC)和评估尼古丁传递对转换、可接受性的作用 以及健康结果的标志物。这项建议的具体目标是招募一支240名现役军人 独家每日吸烟者，并在基线、3岁和6岁时测量一组全面的健康标志物 在尝试完全改用SREC后的几周内，SREC的尼古丁含量为0或15 mg/ml 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 监管科学已经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，以进行与以下相关的健康风险研究 转换到标准化的研究电子文明，有以下三个具体目标：目标1.描述 尝试从传统吸烟转向标准化研究电子烟的短期效果 使用一系列综合措施(例如致癌生物标记物、NNAL、肺功能测试、 血脂、谷胱甘肽、呼出一氧化碳、血尼古丁和可替宁、血压等)超过6周。目标2.比较 含尼古丁与不含尼古丁液体对减少吸烟行为和健康的影响 记号笔。目标3.在每个参与者的6周参与结束时，将向他们提供信息 关于使用烟草产品对健康的影响，如果他们希望继续使用，如何购买SREC用品 和戒烟的帮助来源，他们将被要求完成电话和在线调查4 几周后。