Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
NCT07111234

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

Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-12-24

30

Participants Needed

1

Research Sites

67 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 at least 100 cigarettes
  • Smokes at least 5 cigarettes per day for the past year
Not Eligible

You will not qualify if you...

  • Uses other tobacco products (including oral nicotine pouches) more than 10 days per month
  • Has unstable or significant psychiatric conditions (stable past conditions are allowed)
  • Is pregnant, planning to become pregnant, or breastfeeding (verified with urine pregnancy test before each visit)
  • Has had a cardiac event or distress in the past 3 months
  • Is currently trying to quit all tobacco use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

5

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