Design and Methods of a Randomized Cross-over Clinical Trial of Unfiltered Cigarettes on Smoking Behavior and Toxicant Exposure: Study Protocol for a Randomized Cross-over Clinical Trial
Year: 2020
Type: preprint
Study design: Study Protocol
Abstract: 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.Methods: The trial involves a 1-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes (groups randomly assignd), 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). 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.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. Trial Registration: NCT03749876
Authors: Eyal Oren, Kim Pulvers, Devan R. Romero, Casey Barber, Erika Carter, Thomas E. Novotny
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W3112997707