THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health (NCT07503925) | Clinical Trial Compass
Not Yet RecruitingPhase 4
THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health
United States15 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
* Exhaled CO reading \<10 ppm
* Owns a smartphone and can receive SMS text messages with embedded survey links
* Negative pregnancy test at V1 and V2 (if applicable)
* Uses ≥1.5 cans of ONPs/week
* Daily use of ONPs for the past 3 months
* At least half of ONPs used are 6mg nicotine concentration.
Exclusion Criteria:
* 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
* Non-nicotine users and regular tobacco users are excluded from the clinical trial component to ensure that participants have established use patterns appropriate for assessing ONP use behaviors.
What they're measuring
1
Nicotine Delivery, Cmax
Timeframe: 2 weeks
Trial details
NCT IDNCT07503925
SponsorOhio State University Comprehensive Cancer Center
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-12-31
Contact for this trial
The Ohio State University Comprehensive Cancer Center