THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07503925
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Tobacco-Related Carcinoma

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Nicotine Oral Pouch — DRUG
    Insert small particle size ONP
  • Nicotine Oral Pouch — DRUG
    Insert variable particle size ONP
  • Survey Administration — OTHER
    Ancillary studies
  • Text Message-Based Navigation Intervention — OTHER
    Receive text with a link to daily diary surveys

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Small particle size oral nicotine pouches
    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.
  • Experimental: Variable particle size oral nicotine pouches
    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.

Primary Outcome Measure

Nicotine Delivery, Cmax [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Brittney L. Keller-Hamilton, PhD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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