Nicotine Oral Pouches for Public Health Study

(THRIVE Trial)

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Brittney L. Keller-Hamilton, PhD, MPH

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Negative pregnancy test at V1 and V2 (if applicable)

I am willing to avoid tobacco, nicotine, and marijuana for 12 hours before study visits.

Uses ≥1.5 cans of ONPs/week

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

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Oral Pouch

How Is the Trial Designed?

Group I: Variable particle size oral nicotine pouches Experimental Treatment 4 Interventions

CLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study. SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.

Group II: Small particle size oral nicotine pouches Experimental Treatment 4 Interventions

CLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study. SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+