The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.
Investigators will recruit 100 young adult cigarette smokers to a 40-day, laboratory-based protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day baseline period, then receive your own brand free-of-charge for an additional 5-day period, and then will receive free, investigational low nicotine cigarettes for the remaining study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in three varieties; each variety will be used for a 10-day period, in counterbalanced order. Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e., carbon monoxide \[CO\]). You will complete in-person visits at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) every 5 days, for a total of nine in-person visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Study-supplied cigarettes will contain either intermediate or very low nicotine content
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Daily cigarette consumption
Daily cigarette consumption will be assessed primarily by participant self-report and secondarily through collection of spent filters for all cigarettes smoked during the 35-day study period, and will be averaged across baseline and pack color periods.
Time frame: Days 0 through 40
Total puff volume
Total puff volume (total smoke inhaled per cigarette) will be collected twice during laboratory visits using a handheld, portable, electronic topography device. Assessments will be averaged across study periods.
Time frame: Days 0, 5, 10, 15, 20, 25, 30, 35, and 40
Risk perceptions
Perceptions of risks of using study cigarettes will be assessed at the end of own brand and pack color periods using individual items and a summary score from an 8-item, 5-point Likert scale (1 = "definitely untrue", 5 = "definitely true") stating: "Compared to your own cigarettes, the cigarettes you are currently smoking…": a) "are lower in nicotine", b) "are lower in tar", c) "are less addictive", d) "are less likely to cause cancer", e) "have fewer chemicals", f) "are healthier", g) "make smoking safer", h) "help people quit smoking."
Time frame: Days 10, 20, 30, and 40
Harm exposure
Harm exposure will be approximated by changes in expired air carbon monoxide (CO), a commonly used biochemical measure of tobacco smoke exposure that is sensitive to changes in puffing behavior. We will assess CO at the onset of each visit to represent daily exposure, as well as before and after each cigarette smoked during laboratory visits. The change in CO values resulting from smoking a cigarette will estimates smoke exposure due to smoking an individual cigarette.
Time frame: Days 0, 5, 10, 15, 20, 25, 30, 35, and 40
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