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

NCT07111234 | Recruiting DMC

• 2 other identifiers: OSU-24236NCI-2025-04693
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

Chill (WS-3 only)

EXPERIMENTAL

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.

Procedure: Carbon Monoxide Measurement; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration

Menthol (menthol only)

EXPERIMENTAL

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.

Procedure: Carbon Monoxide Measurement; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration

Peppermint (menthol+WS-3)

EXPERIMENTAL

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.

Procedure: Carbon Monoxide Measurement; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration

Smooth (no menthol or WS-3)

EXPERIMENTAL

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.

Procedure: Carbon Monoxide Measurement; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration

Usual brand cigarette visit

EXPERIMENTAL

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.

Procedure: Carbon Monoxide Measurement; Other: Questionnaire Administration; Drug: Smoke usual brand cigarette

Interventions

Carbon Monoxide Measurement PROCEDURE

Ancillary studies

Also known as: Carbon Monoxide, CMONOX

Chill (WS-3 only); Menthol (menthol only); Peppermint (menthol+WS-3); Smooth (no menthol or WS-3); Usual brand cigarette visit

Nicotine Oral Pouch DRUG

Sample randomly-ordered ONPs

Also known as: ZYN

Chill (WS-3 only); Menthol (menthol only); Peppermint (menthol+WS-3); Smooth (no menthol or WS-3)

Questionnaire Administration OTHER

Ancillary studies

Chill (WS-3 only); Menthol (menthol only); Peppermint (menthol+WS-3); Smooth (no menthol or WS-3); Usual brand cigarette visit

Smoke usual brand cigarette DRUG

Participant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.

Usual brand cigarette visit

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Carbon Monoxide

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• Brittney L Keller-Hamilton, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 8, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-11

Locations

US (1)