NCT06179290

Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products

A Multi-site, Open-Label, Parallel-Group Study To Evaluate Changes In Tobacco-Related Biomarkers of Exposure and Biomarkers of Potential Harm With Use of Heated Tobacco Products Compared to Combustible Cigarettes in Adult Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 921 (actual)
• Sponsor: Altria Client Services LLC · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate changes in biomarkers of exposure (BoE) to harmful and potentially harmful constituents (HPHCs) in adult smokers who completely switch to Ploom heated tobacco products (HTPs) compared to those who continue to smoke usual brand combustible cigarettes (UBCC).

Detailed description

This is a multi-site, open-label, two-group (menthol and non-menthol), six-arm (HTP, Continue Smoking, and Smoking Abstinence arms within each group) randomized, clinical study to evaluate changes in BoEs in adult smokers who remain smoking, switch to the Ploom HTP, or abstain from smoking, for 60 days (5 days in clinic followed by a 55-day ambulatory phase). Target enrollment is 300 male and female adult smokers between the ages of 22 and 65 in overall good health.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	Ploom HTP Menthol HTS; MX3 (681)	Menthol heated tobacco product
OTHER	Ploom HTP Tobacco HTS; R8 (120)	Non-menthol heated tobacco product
OTHER	Smoking Abstinence (menthol)	No smoking or other tobacco product use for duration of the study, menthol group comparator
OTHER	Smoking Abstinence (non-menthol)	No smoking or other tobacco product use for duration of the study, non-menthol group comparator

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-05-15
• Completion: 2025-03-24
• First posted: 2023-12-21
• Last updated: 2025-05-04

Locations

7 sites across 1 country: United States