Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carbon Monoxide Measurement, Nicotine Oral Pouch, Questionnaire Administration, Smoke usual brand cigarette.
- Who it may be relevant to
- Registry conditions: Cigarette Smoking-Related Carcinoma. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Examining the Role of Cooling Agents in Oral Nicotine Pouches
Overview
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:
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.
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.]
- 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]
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Ohio State University Comprehensive Cancer Center — Columbus
Identifiers
NCT: NCT07111234 · OSU-24236 · NCI-2025-04693