Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-29

Study Completion Date

2018-07-26

Brief Summary

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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.

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Detailed Description

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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

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Nicotine Dependence Nicotine Dependence, Cigarettes Tobacco Use Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tobacco flavored JUUL 1.7% ENDS

Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Group Type EXPERIMENTAL

Tobacco flavored JUUL 1.7% ENDS

Intervention Type OTHER

Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Tobacco flavored JUUL 5% ENDS

Tobacco flavored JUUL 5% ENDS (10 puffs)

Group Type EXPERIMENTAL

Tobacco flavored JUUL 5% ENDS

Intervention Type OTHER

Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)

Mint flavored JUUL 1.7% ENDS

Mint flavored JUUL 1.7% ENDS (10 puffs);

Group Type EXPERIMENTAL

Mint flavored JUUL 1.7% ENDS

Intervention Type OTHER

Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)

Mint flavored JUUL 5% ENDS

Mint flavored JUUL 5% ENDS (10 puffs)

Group Type EXPERIMENTAL

Mint flavored JUUL 5% ENDS

Intervention Type OTHER

Treatment with Mint flavored JUUL 5% ENDS(10 puffs)

Fruit Medley flavored JUUL 1.7% ENDS

Fruit Medley flavored JUUL 1.7% ENDS (10 puffs)

Group Type EXPERIMENTAL

Fruit Medley flavored JUUL 1.7% ENDS

Intervention Type OTHER

Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)

Fruit Medley flavored JUUL 5% ENDS

Fruit Medley flavored JUUL 5% ENDS (10 puffs)

Group Type EXPERIMENTAL

Fruit Medley flavored JUUL 5% ENDS

Intervention Type OTHER

Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)

Crème brulee flavored JUUL 1.7% ENDS

Crème brulee flavored JUUL 1.7% ENDS (10 puffs)

Group Type EXPERIMENTAL

Crème brulee flavored JUUL 1.7% ENDS

Intervention Type OTHER

Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)

Crème brulee flavored JUUL 5% ENDS

Crème brulee flavored JUUL 5% ENDS (10 puffs)

Group Type EXPERIMENTAL

Crème brulee flavored JUUL 5% ENDS

Intervention Type OTHER

Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)

JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

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

Group Type EXPERIMENTAL

JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

Intervention Type OTHER

Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs

JUUL 5% ENDS 10 puffs vs. ad lib puffs

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

Group Type EXPERIMENTAL

JUUL 5% ENDS 10 puffs vs. ad lib puffs

Intervention Type OTHER

Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs

Interventions

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Tobacco flavored JUUL 1.7% ENDS

Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Intervention Type OTHER

Tobacco flavored JUUL 5% ENDS

Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)

Intervention Type OTHER

Mint flavored JUUL 1.7% ENDS

Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)

Intervention Type OTHER

Mint flavored JUUL 5% ENDS

Treatment with Mint flavored JUUL 5% ENDS(10 puffs)

Intervention Type OTHER

Fruit Medley flavored JUUL 1.7% ENDS

Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)

Intervention Type OTHER

Fruit Medley flavored JUUL 5% ENDS

Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)

Intervention Type OTHER

Crème brulee flavored JUUL 1.7% ENDS

Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)

Intervention Type OTHER

Crème brulee flavored JUUL 5% ENDS

Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)

Intervention Type OTHER

JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs

Intervention Type OTHER

JUUL 5% ENDS 10 puffs vs. ad lib puffs

Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes