NCT01989156

Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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).

Detailed description

The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS) 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) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	THS 2.2 Menthol (mTHS 2.2)	THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting
OTHER	Menthol Conventional Cigarette (mCC)	Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting
OTHER	Smoking Abstinence (SA)	SA for 5 days in confinement prolonged by 86 days in an ambulatory setting

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-10-01
• Completion: 2015-05-01
• First posted: 2013-11-20
• Last updated: 2020-03-24
• Results posted: 2017-04-05

Locations

2 sites across 1 country: United States