NCT03719391

United States Pre-Market Tobacco Application Pharmacokinetics

A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Juul Labs, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum 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 inhaltion 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 assess nicotine uptake during a 10-puff controlled and a 5-minute ad libitum use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.

Conditions

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

Interventions

Type	Name	Description
OTHER	Virginia Tobacco flavored JUUL 5% ENDS	Treatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs).
OTHER	Cool Mint flavored JUUL 5% ENDS	Treatment with Cool Mint flavored JUUL 5% ENDS (10 puffs).
OTHER	Mango flavored JUUL 5% ENDS	Treatment with Mango flavored JUUL 5% ENDS (10 puffs).
OTHER	Creme Brulee flavored JUUL 5% ENDS	Treatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs).
OTHER	VUSE Solo e-cigarette	Treatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs).
OTHER	Nicorette White Ice Mint 4mg nicotine polacrilex gum	Treatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method)
OTHER	Usual Brand combustible cigarette	Treatment with usual brand cigarette (10 puffs).

Timeline

• Start date: 2018-10-19
• Primary completion: 2018-11-21
• Completion: 2018-11-28
• First posted: 2018-10-25
• Last updated: 2021-06-14

Locations

1 site across 1 country: United States