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

• 批准号: 10413235
• 负责人: PAUL MICHAEL CINCIRIPINI
• 金额: $ 65.86万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 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/10413235
• 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; IL17 gene; Inflammation; Inhalation; Interferon Type II; Interleukin-1 beta; Interleukin-12; 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; 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

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 老年吸烟者患吸烟相关疾病的比例过高，特别是肺癌， 老年吸烟者的吸烟率下降幅度不如年轻吸烟者大。的 大部分的风险是由于长期吸入燃烧的香烟（CC）烟雾。然而，老年吸烟者 与年轻的吸烟者相比，他们往往更不愿意或不能戒烟，这表明他们可能 从转换到潜在危害较小的尼古丁产品中受益。最近的研究，以及来自 FDA建议电子香烟（EC）可能比CC危害更小。然而，不知道如何 EC将用于这一人群，在现实世界的环境中，以及这种使用是否会提供 更安全的替代CC吸烟。本项目将评价产品使用、可接受性、加固、 尼古丁依赖的症状，以及炎症、氧化应激和代谢的生物标志物， 吸烟者在从CC转换为EC时患肺癌的风险很高。受试者（n=330）为吸烟者， 符合肺癌高风险标准，对戒烟不感兴趣，但有兴趣 尝试EC和改变CC消耗。参与者将被随机分配到2种条件之一，EC或 常规品牌（UB）CC，持续6个月（26周）。那些被分配到EC条件的人将抽样选择 从4种EC口味中选出。所有参加者将被强烈鼓励戒烟CC结束时， 研究，如果他们还没有，并将提供免费的标准治疗（NRT和咨询）在我们的诊所，如果 兴趣我们将解决以下具体目标：（1）表征从CC切换到 关于产品使用、产品可接受性和在成人每日CC吸烟者中强化的EC， （2）表征从CC转换为EC对炎症生物标志物的影响， 肺癌高危人群中每日吸烟者的氧化应激;（3）表征代谢组学 在肺癌高危的CC吸烟者中，由CC转换为EC导致的变化;（4） 描述哪些因素调节或介导CC吸烟者从CC转换为EC的影响 患肺癌的风险很高该项目意义重大，因为它将告知监管科学和公共卫生 关于老年吸烟者从CC转换为EC的潜在危害和益处的政策 对戒烟不感兴趣的人患肺癌的风险。这个项目是创新的，因为它将是 是第一批专门关注这一高风险群体并评估其危害和益处的人之一。 使用前瞻性临床试验从CC转换为EC，评估转换的风险和获益 在多个领域，包括行为，成瘾和健康结果。