||5R01CA239309-03 Interpret this number
||University Of Wisconsin-Madison
||Understanding the Real-World Impact of the Use of Three Alternate Nicotine-Delivery Products on Combustible Cigarette Use
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-
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