About this trial
Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products.
This study will be comprised of adults who use nicotine pouches. If eligible, participants will be asked to complete three study visits and participate in two switching periods where participants use study-provided nicotine pouches.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 21 or older
Able to read and speak English
Willing to abstain from tobacco, nicotine, and marijuana for at least 12 hours prior to study visits
Exclusive use of ONPs (other product use <10x/mo).
Disqualifiers
Non-English speaker
Individuals currently pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks associated with nicotine exposure and study procedures (e.g., blood draws).
Individuals with unstable or significant psychiatric conditions are excluded to minimize risk and ensure reliable participation.
Individuals actively attempting to quit nicotine use are excluded to avoid ethical concerns and ensure that study participation does not interfere with cessation efforts
Trial design
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Nicotine Oral Pouch
DrugInsert small particle size ONP
Nicotine Oral Pouch
DrugInsert variable particle size ONP
Survey Administration
Other interventionAncillary studies
Text Message-Based Navigation Intervention
Other interventionReceive text with a link to daily diary surveys
Treatment groups
Trial outcomes
Primary outcomes
Nicotine Delivery, Cmax
Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.
Secondary outcomes
Switching Behavior
Switching behavior will be quantified using the number of days during the switching week that each participant completely switches from their usual ONP to the study product.
Nicotine Delivery, Tmax
The time at which the maximum nicotine concentration is observed in the plasma samples for each participant.
Nicotine Delivery, AUC
Area under the curve (AUC) of plasma nicotine levels versus time for each participant.
Craving Relief, QSU
Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU). This is a 10-item measure where participants rate items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, the investigators will collapse the items into two previously identified factors (Factor 1: strong desire and intention to use; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.