clinical trial · NCT06303115
CSD231005 Nicotine Pouch Biomarkers of Exposure
RAI Services Company·N/A·completed·n = 200
Tobacco UseSmokingNicotine Pouch P1312914, 4 mg nicotineNicotine Pouch P1312915, 8 mg nicotineNicotine Pouch P1013215, 8 mg nicotineNicotine Pouch P1013218, 10 mg nicotineNicotine Pouch P1012919, 12 mg nicotineSmoking AbstinenceContinued UB cigarette smoking
brief 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.
started
Aug 22, 2024
primary completion
Jan 15, 2025
completion
Jan 15, 2025
last updated
Apr 11, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol