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NOT YET RECRUITING
NCT07899827
NA

Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This clinical trial studies how different ways of using oral nicotine pouches (ONPs) affect nicotine delivery, appeal, and side effects among adult cigarette smokers. ONPs are tobacco-free nicotine products that contain nicotine but no tobacco leaf and are used by placing them between the lip and gum. Because ONPs are not burned and do not contain tobacco leaf, they are being studied as a replacement for tobacco products to lower harmful effects, particularly among adult cigarette smokers. However, previous research on ONP use has often been done via controlled assessments which had users place them in one area of the mouth, which does not reflect how they are used in the real-world. Researchers believe this approach leaves gaps in knowledge on how nicotine is delivered, sensory effects, craving and withdrawal, appeal, and side effects. This trial will have participants use ONPs in different ways, such as placed between the upper lip and gum, placed between the lower lip and gum, and placing them however they would like. Researchers hope that by studying these different use patterns they will understand more about how they affect nicotine delivery, appeal, and side effects among adult cigarette smokers.

Official title: The Place Study: Exploring the Effects of Oral Nicotine Pouch Use Topography on Measured Abuse Liability and Adverse Effects

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2027-01-02

Completion Date

2028-12-31

Last Updated

2026-10-28

Healthy Volunteers

Yes

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Oral nicotine pouches

Complete at-home sampling of ONPs

DRUG

Oral nicotine pouches

Use ONP with upper lip and gum placement

DRUG

Oral nicotine pouches

Use ONP with lower lip and gum placement

DRUG

Oral nicotine pouches

Use ONP with ad libitum use

OTHER

Survey Administration

Ancillary studies

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States