The Effects of IQOS Use on Cigarette Smoking Behavior

项目总结 尽管发病率和死亡率有所上升，但美国仍有3400万成年人吸烟。 热不灼伤(HNB)烟草产品是一种新兴的尼古丁传递创新，旨在传递尼古丁 比可燃香烟含有更少的毒素。2019年，美国食品和药物管理局(FDA)授权 销售iQOS，美国唯一的HNB烟草产品。由菲利普莫里斯国际公司制造， IQOS是一种可充电的电子设备，它通过加热一次性产品来产生含有尼古丁的气雾剂 烟棒。自2014年进入烟草市场以来，iQOS的全球销量增长了数百万 50个国家和地区的用户。烟草科学家和市场分析师预测#年iQOS销售将快速增长 美国在接下来的几年里。 虽然吸烟者对iQOS的认识和使用正在增加，但缺乏关于iQOS影响的数据 在吸烟行为上使用IQOS让我们无法回答相关的基本问题 公共卫生和监管方面的努力。首先，吸烟者是完全改用iQOS，还是双重吸烟者？ 使用这两种烟草产品吗？菲利普·莫里斯国际公司声称，使用iQOS会减少接触 比可燃香烟更有害的化学物质取决于吸烟者完全改用iQOS。第二，是否 IQOS的使用会影响吸烟者戒烟的意愿吗？第三，对iQOS的满意度指数如何 使用(例如，渴望和戒断缓解、主观奖励和相对强化价值)以及iQOS风险 感知，影响可燃香烟吸烟？拟议中的研究将填补证据中的这些空白 通过招募100名可燃香烟吸烟者，采用受试者内设计，进行为期21天的方案。 基线吸烟率将在第1-5天确定。在彻夜戒烟后， 第6天和第7天的实验室访问将评估与IQOS相关的渴望缓解、戒断缓解、风险认知、 主观奖励，以及iQOS相对于可燃香烟的强化价值。参与者将切换 从吸烟到在接下来的14天(第8-21天)使用IQOS。参赛者将领取他们的 香烟滤清器及其每天使用的iQOS加热棒，以评估每天的香烟消耗量(CPD) 和烟草条/天(SPD)。主要结果是从基线开始的每日纵向香烟数量 直到iQOS交换阶段结束。戒烟动机从基线到研究结束的变化将是 一个次要的结果。正如RFA-OD-19-028中概述的那样，调查结果将直接涉及FDA的优先事项 评估加热烟草产品对吸烟行为的可能影响(例如，改用、使用、 双重用途和戒烟相关行为)和风险认知。

PROJECT SUMMARY Despite increased morbidity and mortality, 34 million adults in the United States smoke combustible cigarettes. Heat-not-burn (HNB) tobacco products are an emerging nicotine delivery innovation designed to deliver nicotine with less toxins than combustible cigarettes. In 2019, the Food and Drug Administration (FDA) authorized the sale of IQOS, the only HNB tobacco product in the United States. Manufactured by Philip Morris International, IQOS is a rechargeable electronic device that produces a nicotine-containing aerosol by heating a disposable tobacco stick. Since entering the tobacco market in 2014, global sales of IQOS have increased with millions of users across 50 countries. Tobacco scientists and market analysts forecast rapid growth in IQOS sales in the U.S. over the next few years. While awareness and use of IQOS is increasing among cigarette smokers, the lack of data on the impact of IQOS use on cigarette smoking behaviors leaves us unable to answer fundamental questions relevant to public health and regulatory efforts. First, do cigarette smokers switch completely to IQOS or do they dual use these two tobacco products? Phillip Morris International’s claim that IQOS use results in less exposure to harmful chemicals than combustible cigarettes rests on smokers switching completely to IQOS. Second, does IQOS use affect smokers’ intentions to quit smoking cigarettes? Third, how do indices of satisfaction with IQOS use (e.g., craving and withdrawal relief, subjective reward, and relative reinforcing value), as well as IQOS risk perceptions, impact combustible cigarette smoking? The proposed research will fill these gaps in the evidence base by recruiting 100 combustible cigarette smokers to a 21-day protocol using a within-subjects design. Baseline smoking rate will be established during days 1-5. After overnight cigarette smoking abstinence, laboratory visits on days 6 and 7 will assess IQOS-associated craving relief, withdrawal relief, risk perceptions, subjective reward, and the reinforcing value of IQOS relative to combustible cigarettes. Participants will switch from cigarette smoking to IQOS use for the following 14 days (days 8-21). Participants will collect their spent cigarette filters and their used IQOS HeatSticks daily in order to assess consumption of cigarettes per day (cpd) and tobacco sticks per day (spd). The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the IQOS switch phase. Changes in motivation to quit smoking from baseline to study end will be a secondary outcome. As outlined in RFA-OD-19-028, the findings will directly address FDA’s priority to assess the likely impact of heated tobacco products on cigarette smoking behaviors (i.e., switching, use, dual use and smoking cessation-related behaviors) and risk perceptions.