THRIVE Study: Informing Oral Nicotine Pouch Regulations to Promote Public Health

Ohio State University Comprehensive Cancer Center

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.

Description

This investigation expands on the parent study's Aims 1 and 2 by examining the effects of a feature that the investigators have identified varies across nicotine pouches (ONP): particle size. The investigators expect that particle size differences may translate to differences in user experience. The investigators wish to further explore this hypothesis among current ONP users. Data will be captured over the course of 3 clinic visits and across two week-long switching periods with daily diary surveys. This will inform interpretation of results from Aims 1 and 2, including how to translate those…

Eligibility

Age range: 21+ years
Sex: All
Healthy volunteers: Yes

Detailed criteria

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 preg…

Interventions

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

Location

Ohio State University Comprehensive Cancer Center
Columbus, Ohio