The potential risks and benefits of electronic cigarettes to older smokers at high risk for lung cancer

电子烟对肺癌高危老年吸烟者的潜在风险和益处

基本信息

批准号：
10248295
负责人：
PAUL MICHAEL CINCIRIPINI
金额：
$ 67.2万
依托单位：
UNIVERSITY OF TX MD ANDERSON CAN CTR
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10248295
关键词：
Address Adult Affect Alkaloids Behavior Benefits and Risks Biological Markers C-reactive protein CCL2 gene Cancer Etiology Carbon Monoxide Cessation of life Chronic Chronic Disease Cigarette Cigarette Smoker Clinic Clinical Trials Consumption Counseling Data Dependence Dinoprost Ecological momentary assessment Elderly Electronic Nicotine Delivery Systems Electronic cigarette Genus Mentha Glutamates Guidelines Health Health Policy Inflammation Inhalation Interferon Type II Interferons Interleukin-1 beta Interleukin-12 Interleukin-17 Interleukin-6 Interleukin-8 JUUL Lecithin Leukocytes Lysophosphatidylcholines Malignant Neoplasms Malignant neoplasm of lung Mango - dietary Measures Mediating Metabolic Metabolism Minor National Comprehensive Cancer Network Nicotine Nicotine Dependence Nicotine Withdrawal Outcome Outcome Measure Oxidative Stress Participant Population Process Psychological reinforcement Public Health Randomized Research Risk Safety Sampling Science Serum Shapes Smoke Smoker Symptoms TNF gene Time Tobacco Tryptophan Virginia Weight White Blood Cell Count procedure Woman addiction cigarette smoke cigarette smoking craving electronic cigarette use high risk high risk population innovation interest lung cancer screening men metabolomics non-smoker oxidized low density lipoprotein primary outcome prospective receptor for advanced glycation endproducts smoking cessation smoking prevalence smoking-related disease standard care

项目摘要

PROJECT SUMMARY Older smokers suffer disproportionately from smoking-related disease, particularly lung cancer, and smoking prevalence among older smokers has not declined as steeply as that of younger smokers. The majority of risk results from the chronic inhalation of combusted cigarette (CC) smoke. However, older smokers are often more unwilling or unable to quit smoking than younger smokers, which suggests that they might benefit from switching to potentially less harmful nicotine products. Recent studies, as well as statements from the FDA, suggest that electronic cigarettes (ECs), may be less harmful than CCs. However, it is unknown how ECs would be used in this population, in a real-world setting, and whether or not such use would provide a safer alternative to CC smoking. This project will evaluate changes in product use, acceptability, reinforcement, symptoms of nicotine dependence, and biomarkers of inflammation, oxidative stress, and metabolism in smokers at high risk of lung cancer as they switch from CCs to ECs. Participants (n=330) will be smokers who meet criteria for high risk of lung cancer, who are uninterested in quitting smoking, but who are interested trying ECs and changing CC consumption. Participants will be randomly assigned to one of 2 conditions, EC or usual brand (UB) CC, for 6 months (26 weeks). Those assigned to the EC condition will sample and choose from among 4 EC flavors. All participants will be strongly encouraged to quit CC smoking at the end of the study if they have not already, and will be offered free standard treatment (NRT and counseling) in our clinic, if interested. We will address the following specific aims: (1) To characterize the effects of switching from CCs to ECs on product use, product acceptability, and reinforcement among adult daily CC smokers at high risk for lung cancer; (2) To characterize the effects of switching from CCs to ECs on biomarkers of inflammation and oxidative stress among adult daily CC smokers at high risk for lung cancer; (3) To characterize metabolomic changes that result from switching from CCs to ECs among CC smokers at high risk for lung cancer; (4) To characterize which factors moderate or mediate the effects of switching from CCs to ECs among CC smokers at high risk for lung cancer. This project is significant because it will inform regulatory science and public health policy about the potential harms and benefits of switching from CCs to ECs in older adult smokers at greatest risk for lung cancer who are uninterested in quitting CC smoking. This project is innovative because it will be among the first to focus exclusively on this high risk group and to evaluate the harms and benefits the effect of switching from CCs to ECs using a prospective clinical trial, that accesses the risks and benefits of switching across multiple domains, including behavior, addiction, and health outcomes.

项目摘要年龄较大的吸烟者因吸烟相关疾病，尤其是肺癌和年长吸烟者的吸烟率并没有像年轻吸烟者那样急剧下降。这大多数风险是由于燃烧香烟（CC）烟雾的长期吸入。但是，年长的吸烟者通常比年轻吸烟者更不愿意或无法戒烟，这表明他们可能从切换到潜在的危害较小的尼古丁产品中受益。最近的研究以及 FDA表明电子烟（EC）可能不如CCS危害。但是，这是未知的 ECS将在现实世界中用于该人群，并且这种使用是否会提供更安全的CC吸烟替代品。该项目将评估产品使用，可接受性，增强，尼古丁依赖性的症状以及炎症，氧化应激和代谢的生物标志物吸烟者从CCS转向EC时患有肺癌的高风险。参与者（n = 330）将是吸烟者满足对肺癌高风险的标准，他们对戒烟不感兴趣，但感兴趣的人尝试ECS并改变CC消耗。参与者将被随机分配到2个条件之一，EC或通常的品牌（UB）CC，持续6个月（26周）。分配给EC条件的人会采样并选择从4种EC的口味中。强烈建议所有参与者在结束时退出CC吸烟学习是否尚未，并将在我们的诊所提供免费的标准治疗（NRT和咨询），如果感兴趣的。我们将解决以下特定目的：（1）表征从CCS切换到CCS的影响成人每日吸烟者的产品使用，产品可接受性和增强的EC 肺癌；（2）表征从CCS转换为ECS对炎症和成人每日吸烟者的氧化应激，患有肺癌的高风险；（3）表征代谢组 CC吸烟者在肺癌高风险中从CCS转换为ECS导致的变化；（4）至表征哪些因素中等或介导CC吸烟者中CCS转换为EC的影响肺癌的高风险。该项目很重要，因为它将为监管科学和公共卫生提供信息关于最大的老年人吸烟者将CCS转换为ECS的潜在危害和益处的政策对戒烟CC吸烟不感兴趣的肺癌的风险。这个项目具有创新性，因为它将是在第一个专门关注这个高风险群体并评估危害和利益的危害和受益使用前瞻性临床试验从CCS切换到ECS，该试验可访问转换的风险和好处跨多个领域，包括行为，成瘾和健康成果。