NCT06303115

CSD231005 Nicotine Pouch Biomarkers of Exposure

A Multi Site, Open Label, Parallel Group Study to Assess Changes in Tobacco Related Biomarkers of Exposure Following Switching From Smoking of Combustible Cigarettes to Exclusive Use of Nicotine Pouches in Adult Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.

Conditions

• Tobacco Use
• Smoking

Interventions

Type	Name	Description
OTHER	Nicotine Pouch P1312914, 4 mg nicotine	P1312914 pouch product
OTHER	Nicotine Pouch P1312915, 8 mg nicotine	P1312915 pouch product
OTHER	Nicotine Pouch P1013215, 8 mg nicotine	P1013215 pouch product
OTHER	Nicotine Pouch P1013218, 10 mg nicotine	P1013218 pouch product
OTHER	Nicotine Pouch P1012919, 12 mg nicotine	P1012919 pouch product
OTHER	Smoking Abstinence	No tobacco/nicotine
OTHER	Continued UB cigarette smoking	Usual Brand Cigarette

Timeline

• Start date: 2024-08-22
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2024-03-12
• Last updated: 2025-04-11

Locations

5 sites across 1 country: United States