NCT04800211

Biomarkers of Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to E-vapor Products

An Open-Label, Parallel-Group, Controlled Study to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure and Biomarkers of Potential Harm in Adult Smokers Who Completely Switch to Using e-Vapor Products for 24 Weeks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Altria Client Services LLC · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to estimate changes in biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in adult cigarette smokers (AS) who switched to using an e-vapor product (EVP) relative to adult smokers who continue smoking exclusively.

Detailed description

This study was conducted as a randomized, parallel-group, open-label, 24-week, controlled clinical study split into an initial 12-week study (Study 1), with a follow-up at 24 weeks (Study 2) in a sub-population of switchers. For Study 1 a total of 450 subjects were enrolled. Of those subjects who successfully completed Study 1, 150 were then enrolled into Study 2 with no interruption in study participation. The study compared changes in BoE and BoPH in AS who switched to ad libitum use of one of two test EVPs with those in the Control group who continued to smoke conventional cigarettes. The study enrolled AS who were considered to be in overall good health.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	Experimental: Test Product 1	Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
OTHER	Experimental: Test Product 2	Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)

Timeline

• Start date: 2017-01-17
• Primary completion: 2018-07-20
• Completion: 2018-11-06
• First posted: 2021-03-16
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

10 sites across 1 country: United States