Cigarette Smoking-Related CarcinomaNCT07111234
Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences
A study testing Carbon Monoxide Measurement, Nicotine Oral Pouch and Questionnaire Administration in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Carbon Monoxide Measurement, Nicotine Oral Pouch and Questionnaire Administration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Brittney L. Keller-Hamilton, PhD, MPH, 614-366-9652, keller-hamilton.1@osu.edu
Brittney L. Keller-Hamilton, PhD, MPH
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Carbon Monoxide Measurement, Nicotine Oral Pouch, Questionnaire Administration, Smoke usual brand cigarette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Monoxide MeasurementProcedure or surgery
Also called Carbon Monoxide, CMONOX
Ancillary studies
Nicotine Oral PouchDrug
Also called ZYN
Sample randomly-ordered ONPs
Questionnaire AdministrationOther
Ancillary studies
Smoke usual brand cigaretteDrug
Participant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Carbon Monoxide Measurement; Other: Questionnaire Administration; Drug: Smoke usual brand cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittney Keller-Hamilton, Ohio State University Comprehensive Cancer Center
- Investigators
- Brittney L Keller-Hamilton, PhD, MPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111234
- Sponsor's protocol ID
- OSU-24236
- Other IDs
- NCI-2025-04693
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No