Clinical Trial

Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences

Recruiting
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Summary
This clinical trial studies how the flavors and synthetic coolant properties in oral nicotine pouches (ONPs) compare to one another and how these characteristics are perceived by users. ONPs are placed between the gum and lip, and the nicotine is absorbed in the mouth. They have a strong potential for harm reduction if smokers can switch to using them, and they are growing in popularity. One factor that could be contributing to the increase in popularity is the wide range of flavors, including mint or menthol. With recent flavor restriction policies that have gone into effect in certain areas of the United States, ONPs are now including synthetic cooling agents (WS-3) in place of the flavors. They provide a cooling sensation, but do not have a characterizing flavor, like mint or menthol, allowing them to be sold where flavor restriction policies are in place. Learning more about the flavors and cooling properties in ONPs and user preferences may help researchers guide future ONP regulation and understand how these characteristics may be used as a potential harm reduction or quit smoking tool.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-06; most recent amendment 2025-12-18.
Status change: Not Yet Recruiting → Recruiting 2025-09-11
Trial Details
NCT Number NCT07111234
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Cigarette Smoking-Related Carcinoma
Enrollment 30 participants
Start Date 2025-09-15
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-24