Erika Carter

Smoking topography (ST) is a set of measures profiling the behavioral characteristics of smoking in various settings. The CReSS portable device can measure ST in the natural environment. No standard protocol exists for measuring ST longitudinally with the CReSS. This study examined the utilization of the CReSS to measure ST and highlights challenges and opportunities in a naturalistic setting. This study is part of a randomized cross-over clinical trial of smoking filtered or unfiltered cigarettes. Participants (n = 43) smoked in each study condition for two weeks using the CReSS device for five days in their naturalistic smoking setting. The devices were calibrated and cleaned during the washout period, and data were downloaded every visit. Five test puffs were administered to calibrate each device. Moderate compliance rates (74.1%) were found with device usage, and the issues encountered were overheating/clogging, incorrectly registered date/time-stamped data, and device repair/replacement. Routine inspection/cleaning and training in device usage were instrumental in mitigating device malfunctioning. The CReSS device proved to be a feasible tool to examine naturalistic smoking topography and the potential impact of changes in tobacco product design on smoking unfiltered cigarettes. This is the first study to examine ST variables longitudinally, measured at multiple time points, and using unfiltered cigarettes.

Background: Plastic filters on cigarette butts are a widespread source of nonbiodegradable, toxic environmental waste. State and local legislation to ban the sale of single-use cigarettes may be considered to prevent this waste, but scientific evidence on the impact of switching smokers to unfiltered cigarettes on smoking behavior and toxicant exposures is needed to inform this policy. We have designed an open-label, randomized, 9-week, crossover clinical trial of adult filtered-cigarette smokers who switch to unfiltered cigarettes. Objective: Our objective is to understand the impact of switching smokers of filtered cigarettes to unfiltered cigarettes on smoking behavior and toxic exposures. Methods: This trial involves a 1-week baseline period; a 2-week period of smoking filtered or unfiltered cigarettes, where groups are randomly assigned; a 3-week washout period; another 1-week baseline period; and a 2-week crossover period of smoking the opposite condition (ie, filtered or unfiltered cigarettes) for a sufficient sample size of 40 participants. We will determine changes in (1) observed topography (ie, puff count, interpuff interval, and puff volume) and cigarettes smoked per day, via butt counts and self-report, (2) expired carbon monoxide and excretion of urinary cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, and volatile organic compounds, and (3) participants’ knowledge and attitudes toward unfiltered cigarettes, satisfaction with smoking, and intention to quit if they were not able to smoke filtered cigarettes. Results: This study was funded in June 2018 and approved by the relevant Institutional Review Boards in July 2018. This study has enrolled 37 participants as of October 2020. Data analysis is currently underway, and trial results are expected to be published in spring 2021. Conclusions: This pilot proof-of-principle study will inform the design of a larger, future research project that can provide robust scientific evidence on our research question. Such a large study could inform possible state or local legislation to ban the sale of single-use filtered cigarettes in order to mitigate the environmental impact of discarded single-use plastic filters. Trial Registration: ClinicalTrials.gov NCT03749876; https://clinicaltrials.gov/ct2/show/NCT03749876 International Registered Report Identifier (IRRID): DERR1-10.2196/19603

BACKGROUND Plastic filters on cigarette butts are a widespread source of nonbiodegradable, toxic environmental waste. State and local legislation to ban the sale of single-use cigarettes may be considered to prevent this waste, but scientific evidence on the impact of switching smokers to unfiltered cigarettes on smoking behavior and toxicant exposures is needed to inform this policy. We have designed an open-label, randomized, 9-week, crossover clinical trial of adult filtered-cigarette smokers who switch to unfiltered cigarettes. OBJECTIVE Our objective is to understand the impact of switching smokers of filtered cigarettes to unfiltered cigarettes on smoking behavior and toxic exposures. METHODS This trial involves a 1-week baseline period; a 2-week period of smoking filtered or unfiltered cigarettes, where groups are randomly assigned; a 3-week washout period; another 1-week baseline period; and a 2-week crossover period of smoking the opposite condition (ie, filtered or unfiltered cigarettes) for a sufficient sample size of 40 participants. We will determine changes in (1) observed topography (ie, puff count, interpuff interval, and puff volume) and cigarettes smoked per day, via butt counts and self-report, (2) expired carbon monoxide and excretion of urinary cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, and volatile organic compounds, and (3) participants’ knowledge and attitudes toward unfiltered cigarettes, satisfaction with smoking, and intention to quit if they were not able to smoke filtered cigarettes. RESULTS This study was funded in June 2018 and approved by the relevant Institutional Review Boards in July 2018. This study has enrolled 37 participants as of October 2020. Data analysis is currently underway, and trial results are expected to be published in spring 2021. CONCLUSIONS This pilot proof-of-principle study will inform the design of a larger, future research project that can provide robust scientific evidence on our research question. Such a large study could inform possible state or local legislation to ban the sale of single-use filtered cigarettes in order to mitigate the environmental impact of discarded single-use plastic filters. CLINICALTRIAL ClinicalTrials.gov NCT03749876; https://clinicaltrials.gov/ct2/show/NCT03749876 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19603