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

可燃卷烟吸烟者转向标准化研究电子烟的预测因素和后果

• 批准号: 10811935
• 负责人: Robin J. Mermelstein
• 金额: $ 15.7万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10811935
• 关键词: Predictors; Consequences; Combustible; Cigarette; Smokers

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.

可燃烟草的使用仍然是美国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。尽管已经取得了巨大的进步 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 考虑各种方法来更快地减少其危害，特别是对那些可能不是吸烟者的人 有戒烟动机或准备戒烟或目前戒烟不成功的人 治疗。这项研究的主要目的是检查传统的、可燃的香烟 吸烟者可以通过改用电子烟(标准化)来减少香烟的使用和相关的危害 研究电子烟或SREC)。该项目将使用生态瞬时评估(EMA)收集 实时、自然地报告传统吸烟者在尝试改用SREC时的使用和体验 从可燃香烟到SREC。我们将考察近端背景和主观体验是如何 周围SREC的使用与吸烟者的模式和对传统香烟使用的反应不同，以及如何 这些差异的模式可能预示着转换的成功。此外，我们将深入、实时地评估， 吸烟者改用SREC时的冲动和戒断症状的报告。我们还将评估以下方面的更改 健康和生物标记物变量。我们将登记180名成年易燃香烟吸烟者的样本，这些人 有兴趣改用电子烟。参与者将完成为期一周的基线均线波动，同时他们 抽他们平时抽的香烟，完成基线评估，然后(在性别内)随机进行 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 接受有关切换的简短行为咨询，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 接收12周的SREC；竞争产品使用的每日报告，以及通过 结束为期12周的试验，然后完成一个月的随访。我们的目标是：1)检查是否 传统的吸烟者可以通过改用SREC显著减少其可燃香烟的使用； 2)审查传统卷烟使用和SREC摄取量的减少是否与变化有关 健康和生物标记物变量；3)实时检查吸烟者对SREC的主观反应 使用，以及这些反应是否与减少吸烟有关；以及4)检查模式如何 SREC的使用(例如，上下文、时机)和主观体验不同于传统的香烟使用，以及 差异是否与成功切换到SREC相关。这项研究的数据将提供 关于吸烟者改用SREC可能减少危害的有价值的信息。