NCT03700112

Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.

An Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 Puff and Ad-libitum) Conditions, in Healthy Adult Smokers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Juul Labs, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers

Detailed description

E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.

Conditions

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

Interventions

Type	Name	Description
OTHER	JUUL Virginia Tobacco flavored 5.0% ENDS	Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum
OTHER	PMI iQOS Heat sticks	PMI IQOS Heat sticks is administered using a controlled method and ad-libitum
OTHER	Reynolds VUSE Solo ENDS - Original	Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum
OTHER	Imperial MyBlu ENDS - Original	Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum
OTHER	Altria MarkTen ENDS - Bold Classic	Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum
OTHER	MLV PHIX ENDS - Original Tobacco	MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum
OTHER	NJOY Daily EXTRA ENDS - Rich Tobacco	NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum
OTHER	Altria Marlboro combustible cigarette - Red	Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum

Timeline

• Start date: 2018-12-04
• Primary completion: 2019-02-24
• Completion: 2019-04-09
• First posted: 2018-10-09
• Last updated: 2021-06-14

Locations

1 site across 1 country: New Zealand