Understanding the real-world impact of the use of three alternate nicotine-delivery products on combustible cigarette use

项目摘要 在美国，吸烟每年导致无数疾病和约50万人死亡，其中包括三分之一 都是死于癌症。尼古丁是烟草中导致持续吸烟的主要因素。新兴产品 例如电子烟允许吸烟者以各种形式和连续的 伤害。FDA概述了一种新的双管齐下的方法，重点是监管尼古丁本身。的目标是 这项研究旨在了解FDA这两个新战略的潜在影响：1)确保 更安全的替代尼古丁输送系统(AND)的可用性，以及2)减少尼古丁含量 将可燃香烟降至不会上瘾的水平。具体地说，我们将审查电子烟和非常低 尼古丁香烟(VLNC)在现实世界中可以取代可燃香烟，这是 受尼古丁贴片中的稳态尼古丁影响。在这项混合设计研究中，180名每日成年吸烟者 不打算戒烟的人将被随机分配到受试者之间的三个水平之一 因素：1)VLNC；2)Juul电子烟；或3)没有替代产品。在两个不同的星期内，参与者将 被要求改用他们平时抽的香烟，只使用学习用的产品。他们还将被要求使用 活性尼古丁或安慰剂贴片(受试者内部因素)，以双盲方式提供 平衡秩序。参与者将记录他们每次使用自己的香烟或任何替代香烟的时间 产品，通过智能手机实时显示，对于某些使用事件，回答有关使用环境的问题 (例如，情感、允许吸烟)和驱动使用行为的可能机制(例如，戒断缓解， 满足、品味)。我们还将研究个人因素的影响，如性别、依赖和 使用行为的精神共病和风险知觉。这项研究将提供关键信息 关于含有或不含有尼古丁的香烟和非成瘾性香烟的影响 替代，在现实世界的环境中，关于吸烟者使用他们通常吸烟的情况和其他结果。这些数据 可为监管政策决策提供信息，以了解土地和非土地利用对公众健康的潜在影响 令人上瘾的香烟。

Project Summary Smoking causes myriad diseases and ~500,000 deaths in the United States each year, including one-third of all cancer deaths. Nicotine is the chief agent in tobacco responsible for continued smoking. Emerging products such as e-cigarettes allow smokers to self-administer nicotine in a variety of forms and on a continuum of harm. The FDA has outlined a new two-pronged approach focusing on regulating nicotine per se. The goal of this research is to understand the potential impact of these two new FDA strategies: 1) to ensure the availability of safer alternative nicotine delivery systems (ANDS), and 2) to reduce the nicotine content in combustible cigarettes to non-addictive levels. Specifically, we will examine how well e-cigarettes and very low nicotine cigarettes (VLNCs) can substitute for combustible cigarettes in real-world settings and whether this is influenced by steady-state nicotine from a nicotine patch. For this mixed design study, 180 daily adult smokers who are not planning to quit smoking will be randomly assigned to one of three levels of the between-subjects factor: 1) VLNCs; 2) Juul e-cigarettes; or 3) no alternative product. During two different weeks, participants will be asked to switch from their usual cigarettes and use only study products. They will also be asked to use either an active nicotine or placebo patch (the within-subjects factor), provided in double-blind fashion and counterbalanced order. Participants will record each time they use their own cigarettes or any alternative product, in real time via a smartphone, and, for some use events, answer questions about the use context (e.g., affect, smoking permitted) and possible mechanisms driving use behavior (e.g., withdrawal alleviation, satisfaction, taste). We will also examine the impact of person factors such as sex, dependence, and psychiatric comorbidity and risk perceptions on use behavior. This research will provide critical information regarding the impact of cigarettes with non-addictive levels of nicotine and ANDS, with or without nicotine replacement, in real-world settings on smokers' use of their usual cigarettes and other outcomes. These data could inform regulatory policy decisions regarding the potential public health impact of ANDS and non- addictive cigarettes.