At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, Open-label, 3-arm Parallel Group, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Apparently Healthy Smokers Switching to the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) or Observing Smoking Abstinence, Compared to Continuing to Use Menthol Conventional Cigarettes, for 5 Days in Confinement and Prolonged by 86 Days in an Ambulatory Setting
In Brief
A clinical study evaluating THS 2.2 Menthol (mTHS 2.2), Menthol Conventional Cigarette (mCC), and 1 other intervention for Smoking. Completed, enrolled 160 participants across 2 sites.
Detailed Summary
Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).
Study Details
Timeline
Interventions
THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting
Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting
SA for 5 days in confinement prolonged by 86 days in an ambulatory setting