Uptake and Patterns of Use of the IQOS Heated Tobacco System by US Smokers

美国吸烟者对 IQOS 加热烟草系统的吸收和使用模式

基本信息

批准号：
10540695
负责人：
Scott R Weaver
金额：
$ 46.73万
依托单位：
GEORGIA STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-01-01 至 2024-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10540695
关键词：
Address Adult Aerosols Authorization documentation Behavior Benefits and Risks Characteristics Cigarette Cigarette Smoker Commerce Complement Country Data Decision Making Disparity Disparity population Electronic Nicotine Delivery Systems Electronics Evaluation Expectancy Focus Groups Future Goals Grant Growth Heating International Japan Knowledge Location Longitudinal Studies Manufacturer Marketing Mediating Methods Modeling Monitor Motivation Nicotine Outcome Outcomes Research Pathway interactions Pattern Perception Policies Population Process Public Health Recording of previous events Research Sales Smoker Smoking South Korea Surveys System Testing Time Tobacco Tobacco Use Cessation Tobacco use Uncertainty United States Food and Drug Administration authority cigarette smoking cigarette user craving design experience follow-up health disparity manufacture non-smoker population health post-market prevent rechargeable battery satisfaction smoking cessation sociodemographic group sociodemographic variables sociodemographics tobacco advertising tobacco products uptake

项目摘要

Project Abstract On April 30, 2019, the U.S. Food and Drug Administration (FDA) issued a marketing order authorizing the IQOS “Tobacco Heating System” (IQOS), manufactured by Phillip Morris International, for interstate commerce in the U.S. The IQOS consists of an electronic system holder with rechargeable battery that heats tobacco-filled sticks (Heatsticks) to generate a nicotine-containing aerosol. Philip Morris USA selected Atlanta, Georgia as its first test market for IQOS and introduced it at multiple retail touchpoints, including IQOS flagship stores, mobile retail units, and Heatstick distribution in approximately 400 retail trade partner stores in October 2019. Crucial in FDA’s marketing order for IQOS were the assessments that IQOS users would be predominantly current cigarette smokers and that a substantial proportion would switch from cigarette smoking to exclusive IQOS use. Greater than anticipated use among nonsmokers or dual-use of IQOS and combusted tobacco could negatively impact population health. However, there remains uncertainty in the actual population health impact of IQOS in the U.S., as FDA’s assessments were based primarily on limited research submitted by PMI and mostly in international markets. At this critical time as IQOS is entering the U.S. market, the objective of this project is to provide unique and timely U.S. postmarket evidence evaluating the sociodemographic and tobacco use patterns of IQOS initiators, including (1) the extent to which adult smokers are: (a) attaining complete cessation of all tobacco products, (b) switching to exclusive IQOS use, (c) continued smoking along with use of IQOS, or (d) product rejection and continued smoking; and (2) the perceptions and use of IQOS by sociodemographic variables relevant to tobacco disparities. Aim 1 will examine the sociodemographic and tobacco use characteristics, putative decision-making processes, and marketing exposure among adult initiators of IQOS. Aim 2 will examine the longitudinal determinants of long-term tobacco use outcomes among adult cigarette smokers who purchased and initiated use of IQOS. These aims will be accomplished by a sequential, mixed-methods design with a consumer survey of 1000 adult IQOS initial purchasers with follow-up surveys of 600 current smokers conducted at 1 month, 6 months, and 12 months. A subsequent focus group study of those adults who had either (a) switched to exclusive IQOS use or (b) were dual using IQOS and cigarettes will be conducted to obtain a deeper understanding of the quantitative findings. The outcome of this research is translatable knowledge regarding the uptake of IQOS and tobacco use patterns and long-term outcomes among current smokers and tobacco disparity populations. The proposed research is expected to have high impact by providing timely findings to enhance FDA’s capacity to evaluate PM USA’s compliance with FDA’s postmarket requirements, assess the potential impact of IQOS’ introduction on adult tobacco use behaviors, and evaluate PMTA and policies for ENDS and other tobacco products in a tobacco market potentially transformed by IQOS.

项目摘要 2019年4月30日，美国食品药品监督管理局（FDA）发布了授权IQOS上市的销售令 “烟草加热系统”（IQOS），由菲利普莫里斯国际公司制造，用于州际贸易美国 IQOS 由一个带有可充电电池的电子系统支架组成，可加热烟草棒（加热棒）产生含尼古丁的气雾剂，菲利普莫里斯美国公司选择佐治亚州亚特兰大作为其第一个产品。 IQOS 测试市场，并在多个零售接触点引入，包括 IQOS 旗舰店、移动零售 2019 年 10 月，Heatstick 在约 400 家零售贸易合作伙伴商店中分发。 IQOS 的营销订单是对 IQOS 用户将主要是当前卷烟的评估吸烟者中很大一部分人会从吸烟转向只使用 IQOS。非吸烟者的使用量超出预期或 IQOS 和燃烧烟草的双重使用可能会产生负面影响然而，IQOS 对美国人口健康的实际影响仍然存在不确定性。因为 FDA 的评估主要基于 PMI 提交的有限研究，并且大部分是国际研究在 IQOS 进入美国市场的关键时刻，该项目的目标是提供独特的产品。及时的美国上市后证据评估 IQOS 的社会人口统计和烟草使用模式发起者，包括 (1) 成年吸烟者达到以下程度： (a) 完全戒除所有烟草产品，(b) 转为单独使用 IQOS，(c) 在使用 IQOS 的同时继续吸烟，或 (d) 产品拒绝和持续吸烟；(2) 社会人口统计学变量对 IQOS 的看法和使用与烟草差异相关的目标 1 将审查社会人口和烟草使用特征， Aim 2 的成人发起者的假定决策过程和营销曝光度将进行研究。购买香烟的成年吸烟者长期吸烟结果的纵向决定因素并开始使用 IQOS，这些目标将通过连续的、混合方法的设计来实现。对 1000 名成人 IQOS 初始购买者进行消费者调查，并对 600 名当前吸烟者进行跟踪调查随后对患有 (a) 的成年人进行了 1 个月、6 个月和 12 个月时的焦点小组研究。转为单独使用 IQOS 或 (b) 双重使用 IQOS 和香烟将进行以获得更深的了解对定量研究结果的理解。当前吸烟者对 IQOS 的吸收和烟草使用模式以及长期结果和烟草差异拟议的研究预计将通过提供及时的发现来提高人口的影响力。 FDA 评估 PM USA 是否符合 FDA 上市后要求的能力，评估潜力 IQOS 的引入对成人烟草使用行为的影响，并评估 PMTA 和 ENDS 政策烟草市场中的其他烟草产品可能会被 IQOS 改变。