Recruiting

Nicotine PouchesTHRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07503925

Conditions

Tobacco-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Nicotine Oral Pouch

Survey Administration

Text Message-Based Navigation Intervention

Study Details

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

Study ID

NCT07503925

Start date

Jun 26, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Nicotine Oral Pouch

Insert small particle size ONP

Nicotine Oral Pouch

Insert variable particle size ONP

Survey Administration

Ancillary studies

Text Message-Based Navigation Intervention

Receive text with a link to daily diary surveys

Primary outcome measure

Nicotine Delivery, Cmax [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Brittney L. Keller-Hamilton, PhD, MPH

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

Tobacco
Oral Nicotine Pouches
Particle Size
Tobacco Regulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-08-17.