Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

Juul Labs

Status: Completed

Conditions: Nicotine Dependence; Tobacco Smoking; Nicotine Dependence, Cigarettes; Tobacco Use

Treatments: Other: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs; Other: Fruit Medley flavored JUUL 5% ENDS; Other: Crème brulee flavored JUUL 1.7% ENDS; Other: Fruit Medley flavored JUUL 1.7% ENDS; Other: Mint flavored JUUL 1.7% ENDS; Other: Tobacco flavored JUUL 5% ENDS; Other: Mint flavored JUUL 5% ENDS; Other: JUUL 5% ENDS 10 puffs vs. ad lib puffs; Other: Crème brulee flavored JUUL 5% ENDS; Other: Tobacco flavored JUUL 1.7% ENDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03593239

PROT-00008 / v2.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female aged 18 to 60 years of age inclusive.
• Current smoker or e-cigarette user:
• Able to participate, and willing to give written informed consent and to comply with the ° study restrictions.

Exclusion criteria

• Clinically significant abnormality on screening ECG.
• Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
• Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
• Positive result for urine drugs of abuse test or alcohol breath test at screening.
• Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
• Positive urine pregnancy test at screening or Assessment Days in female subjects of child bearing potential.
• Any clinically significant concomitant disease or conditions.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 10 patient groups

Tobacco flavored JUUL 1.7% ENDS

Experimental group

Description:

Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Treatment:

Other: Tobacco flavored JUUL 1.7% ENDS

Tobacco flavored JUUL 5% ENDS

Experimental group

Description:

Tobacco flavored JUUL 5% ENDS (10 puffs)

Treatment:

Other: Tobacco flavored JUUL 5% ENDS

Mint flavored JUUL 1.7% ENDS

Experimental group

Description:

Mint flavored JUUL 1.7% ENDS (10 puffs);

Treatment:

Other: Mint flavored JUUL 1.7% ENDS

Mint flavored JUUL 5% ENDS

Experimental group

Description:

Mint flavored JUUL 5% ENDS (10 puffs)

Treatment:

Other: Mint flavored JUUL 5% ENDS

Fruit Medley flavored JUUL 1.7% ENDS

Experimental group

Description:

Fruit Medley flavored JUUL 1.7% ENDS (10 puffs)

Treatment:

Other: Fruit Medley flavored JUUL 1.7% ENDS

Fruit Medley flavored JUUL 5% ENDS

Experimental group

Description:

Fruit Medley flavored JUUL 5% ENDS (10 puffs)

Treatment:

Other: Fruit Medley flavored JUUL 5% ENDS

Crème brulee flavored JUUL 1.7% ENDS

Experimental group

Description:

Crème brulee flavored JUUL 1.7% ENDS (10 puffs)

Treatment:

Other: Crème brulee flavored JUUL 1.7% ENDS

Crème brulee flavored JUUL 5% ENDS

Experimental group

Description:

Crème brulee flavored JUUL 5% ENDS (10 puffs)

Treatment:

Other: Crème brulee flavored JUUL 5% ENDS

JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

Experimental group

Description:

Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs

Treatment:

Other: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

JUUL 5% ENDS 10 puffs vs. ad lib puffs

Experimental group

Description:

Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs

Treatment:

Other: JUUL 5% ENDS 10 puffs vs. ad lib puffs