NCT07111234 Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences
| NCT ID | NCT07111234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Condition | Cigarette Smoking-Related Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-09-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age 21 years or older * Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits * Ability to read and speak English * Has smoked \>= 100 cigarettes * Smokes \>= 5 cigarettes/day for past year Exclusion Criteria: * Use other tobacco products (including ONPs) more than 10 days per month * Unstable or significant psychiatric conditions (past and stable conditions allowed) * Pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each visit) * History of cardiac event or distress within the past 3 months * Currently attempting to quit all tobacco use
Contact & Investigator
The Ohio State University Comprehensive Cancer Center
✉ OSUCCCClinicaltrials@osumc.edu📞 800-293-5066
Brittney L Keller-Hamilton, PhD, MPH
PRINCIPAL INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07111234 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Cigarette Smoking-Related Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111234 currently recruiting?
Yes, NCT07111234 is actively recruiting participants. Contact the research team at OSUCCCClinicaltrials@osumc.edu for enrollment information.
Where is the NCT07111234 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07111234 clinical trial?
NCT07111234 is sponsored by Ohio State University Comprehensive Cancer Center. The principal investigator is Brittney L Keller-Hamilton, PhD, MPH at Ohio State University Comprehensive Cancer Center. The trial plans to enroll 30 participants.