Effect of tobacco use patterns on toxicant exposure and successful cessation: a longitudinal study among US adult cigarette smokers

项目摘要 在美国，吸烟是可预防的死亡和疾病的主要原因。每年， 超过40万美国人死于与烟草使用有关的原因。强有力的科学证据表明 吸烟与肺部疾病、心血管疾病（如心脏病发作、心脏病）的风险增加有关。 衰竭和中风）和多种类型的癌症（例如口腔癌、肺癌、食道癌、肾癌、子宫癌和 骨髓）。为了遏制这些高死亡率和发病率，保护美国人民，2009年， 《家庭吸烟预防和烟草控制法》授予食品和药物管理局（FDA） 管理所有符合法定要求的产品的制造、分销和营销的权力 烟草制品的定义，定义为任何由烟草制成或衍生的供人类使用的产品。 消费为了告知以科学为基础的烟草法规，目前有必要进行严格的研究， 与毒物暴露和成功戒烟相关的因素，因为过去的工作不太适用于今天的 不断演变的烟草市场和使用模式。烟草使用模式现在包括各种口味的 可燃的（例如，小雪茄）和不可燃烟草产品（例如ECIG）， 同时（双重/多重产品使用）。这些模式可能会产生不同的有毒物质暴露概况（因此， 影响健康结果）和不同程度的尼古丁依赖（从而影响戒烟率）。 对RFA-OD-19-022的回复使用最先进的统计技术分析国家纵向 烟草与健康人口评估研究（PATH）的五次浪潮的数据，以确定 吸烟者的有毒物质暴露，并了解尼古丁的加班模式的趋势 依赖和烟草使用以及它们与成功戒烟的关系。两个具体目标是：1） 对成年现吸烟者和群体吸烟者的烟草生物标志物进行聚类分析， 基于烟草毒物生物标志物浓度的聚类（即，暴露于以下物质的尿生物标志物 尼古丁、TSNA、PAH和VOC）。我们将研究是否使用 模式（如口味、排他性、双重和多重使用）、个人特征和尼古丁依赖性因 集群成员。2)进行生长曲线分析，以模拟尼古丁依赖性随时间的变化， 识别和描述四个期间的依赖轨迹（即不同的尼古丁依赖模式） 连续波，并检查这些轨迹之间的关系，烟草使用的随时间变化 模式，并成功戒烟（3+ m禁欲）。总而言之，该项目解决了优先研究的问题， 并且与FDA CTP的使命直接相关。可以利用所得数据来告知产品 标签和公共卫生运动，特别是那些解决有毒物质暴露和依赖风险的运动， 双/聚产品使用。直到消费者完全了解他们在从事双重/聚乙烯时所承担的风险 烟草产品的使用，我们可以预期越来越多的人从事这种潜在的危险行为。

PROJECT SUMMARY Combustible cigarette smoking is the leading cause of preventable death and disease in the US. Each year, more than 400,000 Americans die due to reasons related to tobacco use. Strong scientific evidence exists linking smoking to elevated risk of pulmonary diseases, cardiovascular diseases (e.g. heart attack, heart failure, and stroke), and multiple types of cancer (e.g. of the oral cavity, lung, esophagus, kidney, uterus, and bone marrow). To curb these high rates of mortality and morbidity and protect the American people, the 2009 Family Smoking Prevention and Tobacco Control Act granted the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of all products that meet the statutory definition of tobacco products, defined as any product made or derived from tobacco and intended for human consumption. To inform science-based tobacco regulations, current rigorous research is necessary on the factors associated with toxicant exposure and successful quitting since past work is less applicable to today’s continually evolving tobacco market and use patterns. Tobacco use patterns now include a variety of flavored combustible (e.g., little cigars) and non-combustible tobacco products (e.g. ECIGs) that may be used concurrently (dual-/poly-product use). These patterns may produce different profiles of toxicant exposure (thus influencing health outcomes), and different levels of nicotine dependence (thus influencing cessation rates). This response to RFA-OD-19-022 uses state-of-the-art statistical techniques to analyze national longitudinal data from five waves of the Population Assessment of Tobacco and Health (PATH) Study, to identify classes of smokers in terms of their toxicant exposure and to understand trends in overtime patterns of nicotine dependence and tobacco use and their relationship with successful quitting. The two specific aims are to: 1) Conduct cluster analysis on tobacco biomarkers of adult current cigarette smokers and group smokers into clusters based on concentrations of tobacco toxicant biomarkers (i.e., urinary biomarkers of exposure to nicotine, TSNAs, PAHs, and VOCs) collected at Wave 3 of the PATH study. We will examine whether use patterns (e.g. flavor, exclusive, dual, and poly use), personal characteristics, and nicotine dependence vary by cluster membership. 2) Perform growth curve analysis to model change over time in nicotine dependence to identify and describe dependence trajectories (i.e. differential nicotine dependence patterns) during four consecutive waves and examine the relationship between these trajectories, overtime change in tobacco use patterns, and successful quitting (3+ m abstinence). In sum, this project addresses priority research questions and is directly relevant to the mission of the FDA’s CTP. Resultant data could be leveraged to inform product labeling and public health campaigns, especially those addressing toxicant exposure and dependence risk of dual/poly product use. Until consumers are fully informed about the risks they take when engaging in dual/poly tobacco product use, we can expect more and more of them to engage in this potentially hazardous behavior.