Ohio State University Comprehensive Cancer Center
Brittney Keller-Hamilton
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.
Cigarette Smoking-Related Carcinoma
Carbon Monoxide Measurement
Nicotine Oral Pouch
Questionnaire Administration
Smoke usual brand cigarette
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 30 participants |
| Masking : | DOUBLE |
| Masking Description : | In a double-blind, randomized crossover design, N=30 adult daily cigarette smokers will sample 4 ONPs with varying flavor and synthetic coolant properties. Participants are blinded to their study product(s) and will not be unblinded. |
| Primary Purpose : | PREVENTION |
| Official Title : | Examining the Role of Cooling Agents in Oral Nicotine Pouches |
| Actual Study Start Date : | 2025-09-30 |
| Estimated Primary Completion Date : | 2026-12-31 |
| Estimated Study Completion Date : | 2026-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 21 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
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RECRUITING
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210