NCT04123041

Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems

A Randomized, Open-Label, Cross-Over Study to Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems With Multiple Flavors and Nicotine Concentrations, Usual Brand of Combustible Cigarettes, a Comparator E-Cigarette and Nicotine Gum in Adult Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Juul Labs, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to estimate nicotine uptake and assess subjective effects during ad libitum use sessions of 4 flavors of JUUL ENDS (also referred to as nicotine salt pod system; NSPS) products (i.e., Virginia Tobacco, Mint, Menthol and Mango) with 2 different nicotine concentrations. Subjective effects will also be assessed to gain an understanding of the user's experience during and after JUUL ENDS product use to evaluate the abuse liability of the products. The subject population will consist of healthy adult, male and female smokers, 21 to 65 years of age.

Conditions

• Electronic Cigarette Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum	JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum

Timeline

• Start date: 2019-09-23
• Primary completion: 2019-12-18
• Completion: 2019-12-18
• First posted: 2019-10-10
• Last updated: 2020-02-13

Locations

2 sites across 1 country: United States