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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Cooling Agents in Oral Nicotine Pouches
- ClinicalTrials.gov ID
- NCT07111234
- Acronym / sponsor ID
- OSU-24236
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chill (WS-3 only) | Experimental | Procedure: Carbon Monoxide Measurement, Drug: Nicotine Oral Pouch, Other: Questionnaire AdministrationParticipants 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. |
| Menthol (menthol only) | Experimental | Procedure: Carbon Monoxide Measurement, Drug: Nicotine Oral Pouch, Other: Questionnaire AdministrationParticipants 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. |
| Peppermint (menthol+WS-3) | Experimental | Procedure: Carbon Monoxide Measurement, Drug: Nicotine Oral Pouch, Other: Questionnaire AdministrationParticipants 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. |
| Smooth (no menthol or WS-3) | Experimental | Procedure: Carbon Monoxide Measurement, Drug: Nicotine Oral Pouch, Other: Questionnaire AdministrationParticipants 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. |
| Usual brand cigarette visit | Experimental | Procedure: Carbon Monoxide Measurement, Other: Questionnaire Administration, Drug: Smoke usual brand cigaretteParticipants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Monoxide MeasurementAlso: Carbon Monoxide, CMONOXAncillary studies | Procedure or surgery | Chill (WS-3 only), Menthol (menthol only), Peppermint (menthol+WS-3), Smooth (no menthol or WS-3), Usual brand cigarette visit |
| Nicotine Oral PouchAlso: ZYNSample randomly-ordered ONPs | Drug | Chill (WS-3 only), Menthol (menthol only), Peppermint (menthol+WS-3), Smooth (no menthol or WS-3) |
| Questionnaire AdministrationAncillary studies | Other | Chill (WS-3 only), Menthol (menthol only), Peppermint (menthol+WS-3), Smooth (no menthol or WS-3), Usual brand cigarette visit |
| Smoke usual brand cigaretteParticipant will smoke their usual brand of cigarette during 1 study visit for 5 minutes. | Drug | Usual brand cigarette visit |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Brittney L Keller-Hamilton, PhD, MPH principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appeal ratings (time frame: 5, 15, and 30 minutes after initial product use. To be completed during the cigarette visit.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.