Understanding the real-world impact of the use of three alternate nicotine-delivery products on combustible cigarette use

了解使用三种替代尼古丁输送产品对可燃卷烟使用的现实影响

基本信息

批准号：
9927613
负责人：
Megan E Piper
金额：
$ 46.49万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-08 至 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9927613
关键词：
Address Adult Affect Alternative Nicotine Delivery Systems Automobile Driving Behavior Belief Cause of Death Cellular Phone Cessation of life Cigarette Data Dependence Devices Disease Double-Blind Method Education Electronic cigarette Enrollment Ensure Event Exposure to FDA approved Gender Goals JUUL Learning Malignant Neoplasms Nicotine Outcome Participant Persons Pharmaceutical Preparations Placebos Policies Public Health Public Policy Race Randomized Research Research Design Risk Risk Factors Self Administration Smoke Smoker Smoking Source Taste Perception Time Tobacco United States Withdrawal Work base cigarette smoking combustible cigarette comorbidity electronic cigarette use evidence base heated tobacco products improved innovation modifiable risk negative affect nicotine patch nicotine replacement novel novel strategies public policy on tobacco response risk perception satisfaction sex smoking cessation smoking restriction time use tobacco products

项目摘要

Project Summary Smoking causes myriad diseases and ~500,000 deaths in the United States each year, including one-third of all cancer deaths. Nicotine is the chief agent in tobacco responsible for continued smoking. Emerging products such as e-cigarettes allow smokers to self-administer nicotine in a variety of forms and on a continuum of harm. The FDA has outlined a new two-pronged approach focusing on regulating nicotine per se. The goal of this research is to understand the potential impact of these two new FDA strategies: 1) to ensure the availability of safer alternative nicotine delivery systems (ANDS), and 2) to reduce the nicotine content in combustible cigarettes to non-addictive levels. Specifically, we will examine how well e-cigarettes and very low nicotine cigarettes (VLNCs) can substitute for combustible cigarettes in real-world settings and whether this is influenced by steady-state nicotine from a nicotine patch. For this mixed design study, 180 daily adult smokers who are not planning to quit smoking will be randomly assigned to one of three levels of the between-subjects factor: 1) VLNCs; 2) Juul e-cigarettes; or 3) no alternative product. During two different weeks, participants will be asked to switch from their usual cigarettes and use only study products. They will also be asked to use either an active nicotine or placebo patch (the within-subjects factor), provided in double-blind fashion and counterbalanced order. Participants will record each time they use their own cigarettes or any alternative product, in real time via a smartphone, and, for some use events, answer questions about the use context (e.g., affect, smoking permitted) and possible mechanisms driving use behavior (e.g., withdrawal alleviation, satisfaction, taste). We will also examine the impact of person factors such as sex, dependence, and psychiatric comorbidity and risk perceptions on use behavior. This research will provide critical information regarding the impact of cigarettes with non-addictive levels of nicotine and ANDS, with or without nicotine replacement, in real-world settings on smokers' use of their usual cigarettes and other outcomes. These data could inform regulatory policy decisions regarding the potential public health impact of ANDS and non- addictive cigarettes.

项目概要在美国，吸烟每年导致多种疾病和约 50 万人死亡，其中三分之一所有癌症死亡。尼古丁是烟草中导致持续吸烟的主要因素。新兴产品例如电子烟允许吸烟者以各种形式和连续的方式自我施用尼古丁伤害。 FDA 概述了一种新的双管齐下的方法，重点是监管尼古丁本身。目标是这项研究旨在了解 FDA 这两项新策略的潜在影响：1）确保更安全的替代尼古丁输送系统 (ANDS) 的可用性，以及 2) 减少尼古丁含量可燃香烟达到不成瘾的程度。具体来说，我们将研究电子烟的效果如何并且非常低尼古丁香烟（VLNC）可以在现实世界中替代可燃香烟，这是否是受到尼古丁贴片中的稳态尼古丁的影响。在这项混合设计研究中，180 名每天吸烟的成年吸烟者不打算戒烟的人将被随机分配到受试者之间的三个级别之一因素：1) VLNC； 2）Juul电子烟；或 3) 没有替代产品。在不同的两周内，参与者将被要求戒掉常用的香烟，只使用研究产品。他们还将被要求使用以双盲方式提供的活性尼古丁贴片或安慰剂贴片（受试者内部因素）平衡秩序。参与者将记录每次使用自己的香烟或任何替代品的时间产品，通过智能手机实时进行，并且对于某些使用事件，回答有关使用上下文的问题（例如，情感、允许吸烟）和驱动使用行为的可能机制（例如，戒断缓解、满意、品味）。我们还将研究个人因素的影响，例如性别、依赖性和精神共病和对使用行为的风险认知。这项研究将提供关键信息关于含有或不含尼古丁的非成瘾水平尼古丁和 ANDS 香烟的影响替代，在现实世界中吸烟者使用平常香烟的情况和其他结果。这些数据可以为有关 ANDS 和非药物的潜在公共卫生影响的监管政策决策提供信息使人上瘾的香烟。