JMIR Publications

ABSTRACT

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. Clinical Trial: ClinicalTrials.gov NCT06072547; https://clinicaltrials.gov/study/NCT06072547