THRIVE Study: Understanding Oral Nicotine Pouches

This study, called THRIVE, aims to understand how adults use oral nicotine pouches (ONPs) and how different types of ONPs affect them. Researchers are looking at how features like particle size in ONPs might change your experience. If you join, you'll use study-provided nicotine pouches and attend three clinic visits. The study will measure how much nicotine is delivered and how quickly it reaches its highest level (Cmax) over two weeks. This information will help us understand how ONPs work and how they compare to other tobacco products. The study is for adults aged 21 and older who regularly use ONPs.

Study design
This is an interventional study involving 15 participants. It expands on previous research by focusing on how particle size in oral nicotine pouches affects users.
What's involved
You would complete three study visits and participate in two week-long periods where you use study-provided nicotine pouches. You'll also receive text messages with links to daily diary surveys.
Compensation
Not stated in the trial record.
Follow-up
Nicotine delivery and Cmax will be measured at 2 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07503925

THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health

Recruiting
PHASE4Ages 21+InterventionalPrevention
Ohio State University Comprehensive Cancer Center
~15 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Biospecimen CollectionNicotine Oral PouchSurvey AdministrationText Message-Based Navigation Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nicotine Delivery, Cmax
Measured over 2 weeks
Tobacco-Related Carcinoma
1 sites across 1 states
Ohio1
  • Brittney L. Keller-Hamilton, PhD, MPH · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
The Ohio State University Comprehensive Cancer Center
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Eligibility criteria

Inclusion

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

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.
  • Nicotine Delivery, Cmax2 weeks

    Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.