How menthol and cooling agents change the appeal of oral nicotine pouches
Official title: Examining the Role of Cooling Agents in Oral Nicotine Pouches
Run by Ohio State University Comprehensive Cancer Center · NCT07111234 · Data updated 2026-11-12
This test checks whether menthol, a synthetic cooling agent (WS-3), or both make oral nicotine pouches more appealing and better at relieving cravings for adult cigarette smokers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 24, 2025 |
| Trial ID | NCT07111234 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥21) who smoke at least 5 cigarettes per day, have a history of ≥100 lifetime cigarettes, are not heavy ONP users, and can abstain from tobacco, nicotine, and marijuana for 12 hours before a single clinic visit.
✕Probably not a fit
People who are pregnant or breastfeeding, currently trying to quit all tobacco, use other tobacco products or ONPs frequently, have had a recent cardiac event, or have unstable psychiatric conditions are unlikely to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult daily cigarette smokers complete a one-visit, four-session randomized crossover in which they sample four oral nicotine pouches presented in random order: WS-3 only, menthol only, menthol+WS-3, and no menthol or WS-3. Each pouch is used for 10 minutes with 10-minute washout periods, while carbon monoxide is measured and participants complete questionnaires about appeal, craving and withdrawal relief, and product demand. The trial compares the individual and combined effects of menthol and WS-3 on subjective appeal, self-reported relief of withdrawal/craving, and demand for the products. Enrollment targets adults who have smoked ≥100 lifetime cigarettes and ≥5 cigarettes per day for the past year and who can abstain from nicotine and marijuana for 12 hours prior to the visit.
Why it matters
Potential benefit: If successful, the results could help guide regulation of flavors and cooling agents and inform product design to support harm-reduction efforts for smokers.
How similar studies have gone: Previous research shows menthol and mint flavors can increase product appeal and influence switching behavior, while studies specifically examining WS-3 (synthetic cooling agents) are limited and relatively new.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Brittney L Keller-Hamilton, PhD, MPH — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.