Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes

在美国，可燃烟草的使用仍然是癌症发病率和死亡率的主要原因， 也是心血管和肺部疾病的主要原因。尽管在过去的十年里 在减少吸烟方面，美国18岁以上的成年人中约有15%目前吸烟， 戒烟的进展可能会停滞不前。为了减少烟草造成的巨大损失，我们需要 考虑各种方法，以更快地减少其危害，特别是对那些吸烟者谁可能不 有戒烟动机或准备戒烟，或目前戒烟不成功 治疗。本研究的主要目的是检查传统的可燃香烟是否 吸烟者可以通过改用电子烟来减少吸烟和相关危害。 研究电子烟或SREC）。该项目将使用生态瞬时评估（EMA）收集 传统吸烟者在尝试转换时对SREC的使用和体验的实时自然报告 从可燃香烟到SREC我们将研究最近的背景和主观经验 周围的SREC使用不同于吸烟者的模式和对传统香烟使用的反应，以及如何 这些差异模式可以预测转换的成功。此外，我们将真实的及时深入评估， 吸烟者报告的冲动和戒断症状，因为他们切换到SREC。我们还将评估 健康和生物标志物变量。我们将招募180名成年可燃香烟吸烟者的样本， 有兴趣转向电子烟。参与者将完成一个基线一周EMA波， 吸烟者，完成基线评估，然后随机分组（性别内 和使用薄荷醇香烟）与尼古丁SREC或安慰剂SREC的比例为2：1。参与者将 接受关于转换的简短行为咨询，在使用SREC的最初一周后，他们将完成 另一个EMA周评估使用SREC和香烟的模式和反应。参与者将 接受12周的SREC;通过 结束为期12周的试验，然后完成为期一个月的随访。我们的目标是：（1）检查是否 传统的吸烟者可以通过改用SREC来显著减少可燃香烟的使用; 2)检查传统香烟使用和SREC摄入的减少是否与变化有关 在健康和生物标志物变量; 3）检查吸烟者的主观反应SREC在真实的时间，因为他们是 使用，以及这些反应是否与香烟减少有关;以及4）检查 使用（例如，背景、时机）和主观体验与传统的香烟使用不同， 差异是否与成功切换到SREC相关。本研究的数据将提供 如果吸烟者改用SREC，则可获得有关潜在危害减少的宝贵信息。

Combustible tobacco use remains the primary cause of cancer morbidity and mortality in the United States, and a major cause of cardiovascular and pulmonary diseases. Although there has been tremendous progress in reducing cigarette smoking, approximately 15% of adults over age 18 in the U.S. currently smoke cigarettes, and progress with smoking cessation may be stalling. To reduce the substantial toll from tobacco, we need to consider a variety of approaches to more rapidly reduce its harm, especially for those smokers who may not be motivated or ready to stop smoking or who have been unsuccessful in quitting with current cessation treatments. The primary purpose of this study is to examine whether conventional, combustible cigarette smokers can reduce their use of cigarettes and associated harms by switching to an e-cigarette (Standardized Research E-Cigarette or SREC). This project will use Ecological Momentary Assessments (EMA) to gather real-time, naturalistic reports of conventional smokers' use and experience of SREC as they attempt to switch from combustible cigarettes to SREC. We will examine how the proximal contexts and subjective experiences surrounding SREC use differ from smokers' patterns and responses to conventional cigarette use, and how these patterns of differences may predict success in switching. In addition, we will assess in-depth, in real time, smokers' reports of urges and withdrawal symptoms as they switch to SREC. We will also evaluate changes in health and biomarker variables. We will enroll a sample of 180 adult combustible cigarette smokers who are interested in switching to e-cigarettes. Participants will complete a baseline one-week EMA wave while they are smoking their usual cigarettes, complete baseline assessments, and then will be randomized (within sex and use of menthol cigarettes) in a 2:1 ratio to either a nicotine SREC or a placebo SREC. Participants will receive brief behavioral counseling about switching, and after an initial week of using SREC, they will complete another EMA week assessing patterns and responses to use of both SREC and cigarettes. Participants will receive 12 weeks of SREC; compete daily reports of product use along with bi-weekly check-ins through the end of the 12-week trial, and then complete a one-month follow-up. Our aims are to: 1) Examine whether conventional cigarette smokers can significantly reduce their combustible cigarette use by switching to SREC; 2) Examine whether reductions in conventional cigarette use and uptake of SREC are associated with changes in health and biomarker variables; 3) Examine smokers' subjective responses to SREC in real time, as they are used, and whether these responses are associated with cigarette reduction; and 4) Examine how patterns of use (e.g., contexts, timing) and subjective experience with SREC differ from conventional cigarette use, and whether differences are associated with success in switching to SREC. Data from this study will provide valuable information about the potential for harm reduction if smokers switch to SREC.