NCT03593239

Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based Electronic Nicotine Delivery System (ENDS Products), in Healthy Adult Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Juul Labs, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

Detailed description

E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhalation of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will provide an understanding of the levels of nicotine obtained with use of the company's 1.7% and 5% ENDS products.

Conditions

• Nicotine Dependence
• Nicotine Dependence, Cigarettes
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Tobacco flavored JUUL 1.7% ENDS	Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)
OTHER	Tobacco flavored JUUL 5% ENDS	Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)
OTHER	Mint flavored JUUL 1.7% ENDS	Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)
OTHER	Mint flavored JUUL 5% ENDS	Treatment with Mint flavored JUUL 5% ENDS(10 puffs)
OTHER	Fruit Medley flavored JUUL 1.7% ENDS	Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)
OTHER	Fruit Medley flavored JUUL 5% ENDS	Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)
OTHER	Crème brulee flavored JUUL 1.7% ENDS	Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)
OTHER	Crème brulee flavored JUUL 5% ENDS	Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)
OTHER	JUUL 1.7% ENDS 10 puffs vs. ad lib puffs	Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs
OTHER	JUUL 5% ENDS 10 puffs vs. ad lib puffs	Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs

Timeline

• Start date: 2018-06-29
• Primary completion: 2018-07-26
• Completion: 2018-07-26
• First posted: 2018-07-20
• Last updated: 2021-06-21

Locations

1 site across 1 country: New Zealand