NCT05664672

Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches

A Randomized, Controlled, Open-label Short-term Study to Evaluate Changes in Exposure to Harmful and Potentially Harmful Constituents in Adult Smokers Who Completely Switch to on!® Nicotine Pouches in a Clinical Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Altria Client Services LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on!® NPs. The study intends to determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who completely switch from smoking to use of on!® NP compared to those who continue smoking cigarettes or stop using all tobacco products.

Detailed description

This is an open-label, randomized, 5 parallel-group clinical study evaluating changes in exposure to selected harmful and potentially harmful constituents (HPHCs) and product use behavior in adult smokers who are randomly assigned to 1 of the 5 groups; continue smoking, partially or completely switch to oral tobacco-derived nicotine products, or stop using any tobacco products for 7 days.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	OTDN Product 1	Mint on!® 2 mg nicotine pouches
OTHER	OTDN Product 2	Mint on!® 4 mg nicotine pouches
OTHER	OTDN Product 3	Mint on!® 8 mg nicotine pouches
OTHER	No Tobacco	subjects completely stop all tobacco product usage for 7 days

Timeline

• Start date: 2021-05-11
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2022-12-27
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

3 sites across 1 country: United States