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Examining the Role of Cooling Agents in Oral Nicotine Pouches
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.
PRIMARY OBJECTIVES: I. Evaluate the individual and joint effects of menthol flavors and WS-3 on appeal of ONPs. II. Test the individual and joint effects of menthol flavors and WS-3 on self-reported relief of withdrawal and craving symptoms associated with use of ONPs. II. Compare demand for ONPs that vary according to menthol flavors and WS-3. OUTLINE: Participants are randomized to sample 4 ONPs in a 1 visit, 4-session, randomized cross-over study. Participants sample four randomly-ordered ONPs with flavors consisting of WS-3 only, menthol only, menthol + WS-3, and no menthol or WS-3 over 10 minutes each, with washout periods of 10 minutes between each ONP use period.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Start Date
September 15, 2025
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
December 24, 2025
30
ESTIMATED participants
Carbon Monoxide Measurement
PROCEDURE
Nicotine Oral Pouch
DRUG
Questionnaire Administration
OTHER
Smoke usual brand cigarette
DRUG
The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066OSUCCCClinicaltrials@osumc.eduLead Sponsor
Ohio State University Comprehensive Cancer Center
NCT07167225
NCT04972513
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06055231