Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 19, 2024
Open Peer Review Period: Jan 20, 2024 - Mar 16, 2024
Date Accepted: May 8, 2024
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effect of flavored on!® nicotine pouch products on smoking behaviors: A sequential multiple assignment randomized controlled trial
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
Citation
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Copyright
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