NCT04107779

Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

A Randomized, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to Using JUUL Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Juul Labs, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to using JUUL Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations

Detailed description

Previous studies and data reported in the literature support that Electronic Nicotine Delivery Systems (ENDS) have less toxicant exposure. This study will serve as a clinical evaluation of exclusive-use of selected JUUL ENDS in 2 different nicotine concentrations (5%, 3%), with the purpose of gaining data to support the hypothesis that exclusive-use of JUUL ENDS over the course of 6 days will result in a significant reduction in toxicant exposure compared to combustible cigarettes. This will be a randomized, open label, parallel group study in adult smokers to be conducted at up to 5 sites in the United States. Changes in Biomarkers of Exposure (BoEs) from baseline when using four JUUL ENDS with 2 different nicotine concentrations (5%, 3%) relative to Usual Brand (UB) of combustible cigarettes and a study group abstaining from any tobacco/nicotine product use will be assessed in this study. JUUL ENDS will be used either exclusively or partially (dual-use), with subjects in the dual-use group using both JUUL 5% ENDS (choice of Virginia Tobacco (VT), Mint, Menthol or Mango flavors) and UB of combustible cigarettes.

Conditions

• Electronic Cigarette Use
• Cigarette Use, Electronic
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS	JUUL 5%, ENDS for 6-days in confinement
OTHER	Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS	JUUL 3%, ENDS for 6-days in confinement
OTHER	Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS	JUUL 5%, ENDS for 6-days in confinement
OTHER	Switch from UB of Combustible Cigarette to JUUL 3% Mint ENDS	JUUL 3%, ENDS for 6-days in confinement
OTHER	Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDS	JUUL 5%, ENDS for 6-days in confinement
OTHER	Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDS	JUUL 3%, ENDS for 6-days in confinement
OTHER	Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDS	JUUL 5%, ENDS for 6-days in confinement
OTHER	Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDS	JUUL 3%, ENDS for 6-days in confinement
OTHER	Switch to Dual-use of JUUL 5% and UB of Combustible Cigarette	Combination use of JUUL 5% (Virginia Tobacco, Mint, Menthol or Mango flavored) and usual brand combustible cigarettes for 6-days in confinement
OTHER	Tobacco/Nicotine Abstention	No smoking for 6-days in confinement.
OTHER	Usual Brand of cigarettes	Continue smoking UB for 6-days in confinement.

Timeline

• Start date: 2019-09-17
• Primary completion: 2020-02-17
• Completion: 2020-06-24
• First posted: 2019-09-27
• Last updated: 2020-07-28

Locations

5 sites across 1 country: United States