NCT03463837

Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers

A Randomized, Open-Label, Parallel-Group Study to Characterize Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Juul Labs, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The JUUL 5% Electronic Nicotine Delivery System (ENDS) is being studied as an alternative to combustible cigarette use. This study aims to find out how much nicotine is in the blood and urine of healthy adult subjects after using three JUUL 5% ENDS compared to smoking usual brands of combustible cigarettes and stopping smoking.

Detailed description

This study will serve as a clinical evaluation of the exclusive use of selected JUUL ENDS, with the purpose of gaining an understanding of toxicant exposure.

Conditions

• Nicotine Dependence, Other Tobacco Product
• Tobacco Use
• Smoking, Tobacco

Interventions

Type	Name	Description
OTHER	Treatment with JUUL 5%, Virginia Tobacco	JUUL 5%, ENDS for 5-days in confinement
OTHER	Treatment with JUUL 5%, Cool Mint, ENDS	JUUL 5%, ENDS for 5-days in confinement
OTHER	Treatment with JUUL 5%, Mango, ENDS	JUUL 5%, ENDS for 5-days in confinement
OTHER	JUUL 5%, Creme Bruele, ENDS	JUUL 5%, ENDS for 5-days in confinement
OTHER	Combustible cigarette	Exclusive use of combustible cigarette for 5 days in confinement.
OTHER	Smoking Cessation	No smoking for 5-days in confinement.

Timeline

• Start date: 2018-03-04
• Primary completion: 2018-07-27
• Completion: 2018-08-13
• First posted: 2018-03-13
• Last updated: 2021-06-21

Locations

1 site across 1 country: United States