About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Carbon Monoxide Measurement
Procedure/SurgeryAncillary studies
Nicotine Oral Pouch
DrugSample randomly-ordered ONPs
Questionnaire Administration
Other interventionAncillary studies
Smoke usual brand cigarette
DrugParticipant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Demand indices
After product use, participants will complete a purchase task to assess demand indices including demand elasticity.
Sponsors and contacts
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