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

Examining the Role of Cooling Agents in Oral Nicotine Pouches

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Carbon Monoxide Measurement; Drug: Nicotine Oral Pouch; Drug: Smoke usual brand cigarette

Detailed Description

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
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Brittney L. Keller-Hamilton, PhD, MPH; Phone Number: 614-366-9652; Email: keller-hamilton.1@osu.edu
      • Principal Investigator: Brittney L. Keller-Hamilton, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Carbon Monoxide Measurement; Ancillary studies; Other Names: Carbon Monoxide; CMONOX; Drug: Nicotine Oral Pouch; Sample randomly-ordered ONPs; Other Names: ZYN
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Carbon Monoxide Measurement; Ancillary studies; Other Names: Carbon Monoxide; CMONOX; Drug: Nicotine Oral Pouch; Sample randomly-ordered ONPs; Other Names: ZYN
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Carbon Monoxide Measurement; Ancillary studies; Other Names: Carbon Monoxide; CMONOX; Drug: Nicotine Oral Pouch; Sample randomly-ordered ONPs; Other Names: ZYN
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Carbon Monoxide Measurement; Ancillary studies; Other Names: Carbon Monoxide; CMONOX; Drug: Nicotine Oral Pouch; Sample randomly-ordered ONPs; Other Names: ZYN
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Carbon Monoxide Measurement; Ancillary studies; Other Names: Carbon Monoxide; CMONOX; Drug: Smoke usual brand cigarette; Participant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appeal ratings	The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective appeal. The 11-item mCEQ includes five subscales: Satisfaction, Psychological Reward, Aversion, Enjoyment, and Craving Reduction. Individual items are rated from 1 (not at all) to 7 (extremely likely) and are averaged to create each subscale also ranging from 1 to 7. Higher values indicate greater levels of satisfaction, reward, aversion, enjoyment, and craving reduction.	5, 15, and 30 minutes after initial product use. To be completed during the cigarette visit.
Sensory ratings	Sensory ratings will be evaluated with the general Labeled Magnitude Scale (gLMS), a 5-item self-report measure completed following ONP use. Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.	5, 15, and 30 minutes after initial product use. To be completed on the day of the study visit. The visit will last approximately 2.5 hours
Withdrawal and Craving	Nicotine withdrawal and craving will be assessed using the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS is the sum of 8 items rated on a 5-point scale from 0 (none) to 4 (severe) with scores ranging from 0 to 32; MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate greater withdrawal/craving.	0, 5, 15, and 30 minutes after initial product use.To be completed on the day of the study visit. The visit will last approximately 2.5 hours
Demand indices	After product use, participants will complete a purchase task to assess demand indices including demand elasticity.	At the end of each ONP sampling session. To be completed on the day of the study visit. The visit will last approximately 2.5 hours

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Brittney L Keller-Hamilton, PhD, MPH, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: August 6, 2025
• First Posted (Actual): August 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Oxides; Oxygen Compounds; Gases; Carbon Compounds, Inorganic; Carbon Monoxide
• Other Study ID Numbers: OSU-24236; NCI-2025-04693 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No