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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07111234
Status
Recruiting
Apply to this trial

Conditions

  • Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Carbon Monoxide Measurement — PROCEDURE
    Ancillary studies
  • Nicotine Oral Pouch — DRUG
    Sample randomly-ordered ONPs
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Smoke usual brand cigarette — DRUG
    Participant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Chill (WS-3 only)
    Participants receive Chill-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
  • Experimental: Menthol (menthol only)
    Participants receive Menthol-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
  • Experimental: Peppermint (menthol+WS-3)
    Participants receive Peppermint-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
  • Experimental: Smooth (no menthol or WS-3)
    Participants receive Smooth-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
  • Experimental: Usual brand cigarette visit
    Participants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task.

Primary Outcome Measure

Appeal ratings [ Time Frame: 5, 15, and 30 minutes after initial product use. To be completed during the cigarette visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Brittney L. Keller-Hamilton, PhD, MPH
[email protected]
614-366-9652
Brittney L. Keller-Hamilton, PhD, MPH (PRINCIPAL_INVESTIGATOR)

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