RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Examining the Role of Cooling Agents in Oral Nicotine Pouches

Quick Facts

Study Start:2025-09-30
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07111234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21 years or older
  2. * Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits
  3. * Ability to read and speak English
  4. * Has smoked \>= 100 cigarettes
  5. * Smokes \>= 5 cigarettes/day for past year
  1. * Use other tobacco products (including ONPs) more than 10 days per month
  2. * Unstable or significant psychiatric conditions (past and stable conditions allowed)
  3. * Pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each visit)
  4. * History of cardiac event or distress within the past 3 months
  5. * Currently attempting to quit all tobacco use

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Brittney L Keller-Hamilton, PhD, MPH
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Brittney L Keller-Hamilton, PhD, MPH, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-30
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-09-30
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cigarette Smoking-Related Carcinoma