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

项目总结 老年吸烟者不成比例地患有与吸烟有关的疾病，特别是肺癌，以及 老年吸烟者的吸烟率并没有像年轻吸烟者那样急剧下降。这个 大多数风险是由长期吸入燃烧香烟(CC)烟雾造成的。然而，年长的吸烟者 通常比年轻吸烟者更不愿意或无法戒烟，这表明他们可能会戒烟 从改用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，电子烟(ECS)的危害可能比CCS小。然而，目前还不清楚是如何 ECS将在现实世界中的人群中使用，无论这种使用是否会提供 比CC吸烟更安全的替代品。该项目将评估产品使用、可接受性、加固、 尼古丁依赖症状，以及炎症、氧化应激和代谢的生物标记物 当吸烟者从CCS转向ECS时，他们患肺癌的风险很高。参与者(n=330)将是吸烟者 符合肺癌高危标准的人，对戒烟不感兴趣，但有兴趣的人 尝试ECS并改变CC消耗。参与者将被随机分配到以下两种情况之一：EC或 普通品牌(UB)CC，为期6个月(26周)。那些被分配到EC条件的人将抽样并选择 从4种EC口味中挑选。强烈鼓励所有参与者在活动结束时戒烟。 如果他们还没有进行研究，并将在我们的诊所提供免费的标准治疗(NRT和咨询)，如果 很感兴趣。我们将解决以下具体目标：(1)描述从CCS切换到 关于成人每日CC吸烟者的产品使用、产品可接受性和强化的ECS 肺癌；(2)从CCS转换为ECS对炎症和细胞生物学标志物的影响 成年每日CC吸烟者中肺癌高危人群的氧化应激反应；(3)代谢特征 在CC吸烟者中，肺癌高危人群从CCS转换为ECS导致的变化；(4) 描述哪些因素对CC吸烟者从CCS转换为ECS的影响起到缓和或中介作用 患肺癌的风险很高。这个项目意义重大，因为它将为监管科学和公共卫生提供信息 关于从CCS改用ECS对老年吸烟者最大的潜在危害和好处的政策 对戒烟不感兴趣的人有患肺癌的风险。这个项目具有创新性，因为它将是 是第一批专门关注这一高危群体并评估其危害和益处的机构之一 使用前瞻性临床试验从CCS切换到ECS，这将获得切换的风险和好处 跨越多个领域，包括行为、成瘾和健康结果。

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.