BACKGROUND
Cigarette smoking is a leading cause of morbidity and mortality. For adults who smoke (AS) and cannot or will not quit smoking, smoke-free products, such as nicotine pouches, have been recognized as a potential alternative to smoking combusted cigarettes to reduce harm due to cigarette smoking. The role of flavors in these smoke-free products in tobacco harm reduction has not been fully understood.
OBJECTIVE
This study evaluates the effect of flavors in on!® nicotine pouch products (research products) in the reduction of cigarette smoking among AS in their natural environment.
METHODS
This study uses a sequential multiple-assignment randomized trial design. Approximately 400 AS eligible will be enrolled and randomized to either access to the Original (unflavored) only or access to a complete flavor profile (i.e., Berry, Cinnamon, Citrus, Coffee, Mint, Original, and Wintergreen) of on!® nicotine pouch products. After 3 weeks, participants in the Original only arm will be randomized again with half remaining in the Original only arm, and half with access to the complete flavor profile for another 3 weeks. Primary outcomes are expired air carbon monoxide (CO) levels. Secondary outcomes are self-reported cigarette consumption and CO-verified cigarette abstinence.
RESULTS
Recruitment and data collection started in September 2023 and is projected to last until November 2024. We anticipate completing the data analysis in 2025.
CONCLUSIONS
This study will provide empirical evidence about the effect that flavor availability in smoke-free products may have in reducing cigarette smoking.
CLINICALTRIAL
ClinicalTrials.gov NCT06072547; https://clinicaltrials.gov/study/NCT06072547