How nicotine pouches affect users and public health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults who currently use nicotine pouches to compare how nicotine concentration, form, and isomer affect satisfaction, appeal, and potential switching from cigarettes. Participants complete three clinic visits and two week-long switching periods with daily diary surveys, using study-provided nicotine pouches. The study examines whether high nicotine content and certain particle characteristics increase user liking and influence switching from cigarettes to nicotine pouches. Results will help interpret prior aims and inform regulation and product design for commercially available nicotine pouches.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Brittney L. Keller-Hamilton, PhD, MPH — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 800-293-5066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.