E-Cigarettes: Dynamic Patterns of Use and Health Effects

描述（由申请人提供）：在美国，吸烟和烟草依赖每年导致无数疾病和近50万人死亡，其中包括所有癌症死亡的三分之一。一种新技术，电子烟（电子烟），允许用户吸入尼古丁蒸汽，已在美国迅速采用。在考虑监管政策的时候，关于电子烟使用及其影响的现有数据非常有限。拟议的研究将提供基于实时报告的深入纵向数据，这将解决美国食品和药物管理局的关键优先事项，包括了解电子烟使用与以下因素之间的关系：1）尼古丁依赖; 2）减少传统香烟（CC）使用; 3）与健康相关的结果，如暴露和致癌物的生物标志物以及急性和长期肺部健康;以及4）尝试停止使用CC以及这些尝试的成功。具体而言，我们将进行一项为期2年的纵向队列研究，包括专门吸烟CC的吸烟者（N=150）和电子烟和CC的双重使用者（N=250）。我们将使用最先进的生态瞬时评估来确定：1）电子烟和CC使用的动态模式和相关结果（例如，依赖性、戒断症状、奖励值和CC戒烟尝试和戒烟成功）; 2）与电子烟和CC使用和相关结果有意义地协变的事件性（情感、背景、社会）和稳定的人因素（生活方式因素、人口统计学）变量;和3）烟草和致癌物暴露的靶向生物标志物以及其他健康相关结果（例如，肺功能）。受试者内数据（来自双重使用组）和组间比较（双重使用与单独使用CC）将使我们能够使用多种强大的分析方法与这个独特的信息数据集。这项研究将提供必要的信息，以告知监管机构，以及研究人员，临床医生和烟草使用者，关于现实世界中电子烟使用的模式，以及这种使用如何与CC吸烟和吸烟引起的健康风险相关。因此，这项创新研究将收集实时数据，为研究公众提供强有力的实证基础 在新政策讨论的这一关键时期，电子烟的使用对健康的影响。

DESCRIPTION (provided by applicant): Smoking and tobacco dependence cause myriad diseases and almost half a million deaths in the United States each year, including one-third of all cancer deaths. A new technology, electronic cigarettes (e-cigs), which allow the user to inhale nicotine vapor, has seen rapid adoption in the US. The extant data on e-cig use and its effects are extremely limited at a time when regulatory policies are being considered. The proposed research will provide in-depth, longitudinal data, based on real-time reports, which will address key priorities for the US Food and Drug Administration, including understanding the relations between e-cig use and: 1) nicotine dependence; 2) reductions in conventional cigarette (CC) use; 3) health-related outcomes such as biomarkers of exposure and carcinogens and acute and long-term pulmonary health; and 4) attempts to quit CC use and the success of those attempts. Specifically, we will conduct a 2-year longitudinal cohort study comprising smokers who exclusively smoke CCs (N=150) and dual users of e-cigs and CCs (N=250). We will use state-of- the-art ecological momentary assessments to determine: 1) dynamic patterns of e-cig and CC use and related outcomes (e.g., dependence, withdrawal symptoms, reward value, and CC quit attempts and quitting success); 2) episodic (affective, contextual, social) and stable person-factor (lifestyle factors, demographics) variables that covary meaningfully with e-cig and CC use and related outcomes; and 3) targeted biomarkers of tobacco and carcinogen exposure as well as other health-related outcomes (e.g., pulmonary function). Both within- subjects data (from the dual use group) and intergroup comparisons (dual use vs. exclusive CC use) will allow us to use multiple powerful analytic approaches with this unique and informative dataset. This research will provide essential information to inform regulatory bodies, as well as researchers, clinicians, and tobacco users, about the patterns of real-world e-cig use and how such use is related to CC smoking and the health risks caused by smoking. Thus, this innovative research will collect real-time data that should provide a strong empirical foundation to examine the public health effects of e-cig use during this critical period of emerging policy discussions.