The Effects of IQOS Use on Cigarette Smoking Behavior

项目摘要 尽管发病率和死亡率增加，但美国仍有3400万成年人吸烟。 加热不燃烧（HNB）烟草产品是一种新兴的尼古丁输送创新，旨在输送尼古丁 有毒物质比可燃香烟少2019年，美国食品药品监督管理局（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，通过加热一次性的 烟草棒自2014年进入烟草市场以来，IQOS的全球销量以数百万美元的速度增长， 50个国家的用户。烟草科学家和市场分析师预测， 美国在未来几年。 虽然吸烟者对IQOS的认识和使用正在增加，但缺乏有关IQOS影响的数据， IQOS对吸烟行为的使用使我们无法回答相关的基本问题 公共卫生和监管工作。首先，吸烟者是完全转向IQOS，还是双重转向 使用这两种烟草产品？菲利普莫里斯国际公司声称，使用IQOS会减少 比可燃香烟更有害的化学物质取决于吸烟者完全转向IQOS。第二， 使用IQOS会影响吸烟者戒烟的意愿吗？第三，如何对IQOS的满意度指数 使用（例如，渴望和戒断救济，主观奖励和相对强化价值），以及IQOS风险 感知，影响可燃性吸烟？拟议中的研究将填补这些证据空白 通过招募100名可燃香烟吸烟者，采用受试者内设计进行21天的方案。 将在第1-5天确定基线吸烟率。经过一夜的戒烟， 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、风险感知， 主观奖励，以及IQOS相对于可燃香烟的强化价值。参与者将转换 从吸烟到使用IQOS，持续14天（第8-21天）。参加者将收集他们的花费 香烟过滤嘴及其使用的IQOS HeatSticks，以评估每天的香烟消耗量（cpd） 和烟草条（SPD）。主要结果是从基线开始的纵向每日香烟计数 到IQOS切换阶段结束。从基线到研究结束戒烟动机的变化将 次要结果。如RFA-OD-19-028所述，这些发现将直接解决FDA的优先事项， 评估加热的烟草产品对吸烟行为的可能影响（即，切换，使用， 双重使用和戒烟相关行为）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.