Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Juul Labs, Inc.

  lead INDUSTRY

Principal Investigators

• Christopher Wynne, MD · Christchurch Clinical Studies Trust Ltd

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-06-29

Primary Completion

2018-07-26

Completion

2018-07-26

Countries

• New Zealand

Study Locations