THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health

NCT07503925 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: OSU-26043
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco-Related Carcinoma

Keywords

Tobacco; Oral Nicotine Pouches; Particle Size; Tobacco Regulation

Outcome Measures

Primary Outcomes (1)

• Nicotine Delivery, Cmax

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

  2 weeks

Secondary Outcomes (7)

• Switching Behavior

  2 weeks

• Nicotine Delivery, Tmax

  2 weeks

• Nicotine Delivery, AUC

  2 weeks

• Craving Relief, QSU

  2 weeks

• Withdrawal, MNWS

  2 weeks

Study Arms (2)

Small particle size oral nicotine pouches

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Survey Administration; Other: Text Message-Based Navigation Intervention

Variable particle size oral nicotine pouches

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Survey Administration; Other: Text Message-Based Navigation Intervention

Interventions

Nicotine Oral Pouch DRUG

Insert small particle size ONP

Small particle size oral nicotine pouches

Survey Administration OTHER

Ancillary studies

Small particle size oral nicotine pouches; Variable particle size oral nicotine pouches

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection

Small particle size oral nicotine pouches; Variable particle size oral nicotine pouches

Text Message-Based Navigation Intervention OTHER

Receive text with a link to daily diary surveys

Also known as: Automated Text Message-Based Navigation

Small particle size oral nicotine pouches; Variable particle size oral nicotine pouches

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

Study Officials

• Brittney L. Keller-Hamilton, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)