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NCT Number: NCT07111234

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

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.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Brittney L. Keller-Hamilton, PhD, MPH

CONTACT

[email protected]

614-366-9652

Brittney L. Keller-Hamilton, PhD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbon Monoxide Measurement

Procedure

Ancillary studies

Other names: Carbon Monoxide, CMONOX

Nicotine Oral Pouch

Drug

Sample randomly-ordered ONPs

Other names: ZYN

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.

Primary outcomes

  1. Appeal ratings

    Time frame: 5, 15, and 30 minutes after initial product use. To be completed during the cigarette visit.

    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.

  2. Sensory ratings

    Time frame: 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

    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.

  3. Withdrawal and Craving

    Time frame: 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

    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.

  4. Demand indices

    Time frame: 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

    After product use, participants will complete a purchase task to assess demand indices including demand elasticity.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Examining the Role of Cooling Agents in Oral Nicotine Pouches

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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