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 2026-07-01
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 range
21 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 4 study measuring how much nicotine oral pouches deliver into the bloodstream — since it's focused on nicotine exposure rather than treating my cancer, how relevant is this kind of research to my own situation with a tobacco-related carcinoma?
2The trial isn't recruiting yet, so if I were interested in something like this down the road, would participating in a nicotine product study be safe or appropriate given my current diagnosis and treatment plan?
3Since this study is measuring peak nicotine levels (Cmax) from oral nicotine pouches, does that mean participants would be using these products during the study — and could that kind of nicotine exposure be harmful for someone with a tobacco-related cancer?
4Given that this is a public health research study rather than a treatment trial, would my doctor recommend I focus on treatment-focused trials instead, or is there a reason this type of research might still be worth my time to consider?
5If the goal of this study is to understand how nicotine pouches affect public health broadly, is there any way the findings from a study like this could eventually influence my treatment or tobacco cessation options as someone already diagnosed with a tobacco-related carcinoma?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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