NCT07111234 · Ohio State University Comprehensive Cancer Center
Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences
What this study is about
This clinical trial studies how the flavors and synthetic coolant properties in taken by mouth 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.
View original scientific description
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.
Interventions
PROCEDURE
Carbon Monoxide Measurement
Ancillary studies
DRUG
Nicotine Oral Pouch
Sample randomly-ordered ONPs
OTHER
Questionnaire Administration
Ancillary studies
DRUG
Smoke usual brand cigarette
Participant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations