Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 24, 2020
Date Accepted: Nov 10, 2020
Effect of Unfiltered Cigarettes on Smoking Behavior and Toxicant Exposure: Study Protocol for a Randomized Cross-over Clinical Trial
ABSTRACT
Background:
Background:
Plastic filters on cigarette butts are a widespread source of non-biodegradable, 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, cross-over clinical trial of adult filtered cigarette smokers who switch to unfiltered cigarettes.
Objective:
Objective:
To understand the impact of switching smokers of filtered cigarettes to unfiltered cigarettes on smoking behavior and toxic exposures.
Methods:
Methods:
The trial involves a 1-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes (groups randomly assigned), a 3-week washout period, another 1-week baseline period, and a crossover to 2-weeks of smoking the opposite condition (filtered or unfiltered cigarettes) for a sufficient sample size (n=40 participants). We will determine changes in: (1) observed topography (i.e., puff count, puff volume) and cigarettes smoked per day (via butt counts and self-report); (2) expired carbon monoxide (CO), urinary cotinine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), and volatile organic compound (VOC) excretion; and (3) knowledge and attitudes toward unfiltered cigarettes, satisfaction with smoking, and intention to quit if they were not able to smoke filtered cigarettes.
Results:
Results:
Funded in June 2018 and approved by the relevant IRBs in July 2018, this study has enrolled 36 participants as of July 2020. Data analysis is currently underway, and results are expected to be published in Spring 2021.
Conclusions:
Discussion: This comprehensive proof-of-principle study will provide preliminary evidence to develop a research project with a larger sample size. Study results will inform proposed state or local legislation to ban the sale of single-use filtered cigarettes in order to eliminate the environmental impact of cigarette butt waste stemming from the single-use plastic filter. Clinical Trial: Trial Registration: NCT03749876
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