Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult 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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-04

Study Completion Date

2018-08-13

Brief Summary

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The JUUL 5% Electronic Nicotine Delivery System (ENDS) is being studied as an alternative to combustible cigarette use. This study aims to find out how much nicotine is in the blood and urine of healthy adult subjects after using three JUUL 5% ENDS compared to smoking usual brands of combustible cigarettes and stopping smoking.

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Detailed Description

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This study will serve as a clinical evaluation of the exclusive use of selected JUUL ENDS, with the purpose of gaining an understanding of toxicant exposure.

Conditions

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Nicotine Dependence, Other Tobacco Product Tobacco Use Smoking, Tobacco

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment with JUUL 5%, Virginia Tobacco

JUUL 5%,Virginia Tobacco \[5 days\] in confinement.

Group Type EXPERIMENTAL

Treatment with JUUL 5%, Virginia Tobacco

Intervention Type OTHER

JUUL 5%, ENDS for 5-days in confinement

Treatment with JUUL 5%, Cool Mint, ENDS

JUUL 5%, Cool Mint \[5 days\] in confinement.

Group Type EXPERIMENTAL

Treatment with JUUL 5%, Cool Mint, ENDS

Intervention Type OTHER

JUUL 5%, ENDS for 5-days in confinement

Treatment with JUUL 5%, Mango, ENDS

JUUL 5%, Mango \[5 days\] in confinement.

Group Type EXPERIMENTAL

Treatment with JUUL 5%, Mango, ENDS

Intervention Type OTHER

JUUL 5%, ENDS for 5-days in confinement

JUUL 5%, Creme Bruele, ENDS

JUUL 5%, Creme Bruele \[5 days\] in confinement.

Group Type EXPERIMENTAL

JUUL 5%, Creme Bruele, ENDS

Intervention Type OTHER

JUUL 5%, ENDS for 5-days in confinement

Combustible cigarette

Exclusive use of combustible cigarette \[5 days\] in confinement.

Group Type ACTIVE_COMPARATOR

Combustible cigarette

Intervention Type OTHER

Exclusive use of combustible cigarette for 5 days in confinement.

Smoking cessation (no smoking)

Smoking cessation (no smoking).

Group Type SHAM_COMPARATOR

Smoking Cessation

Intervention Type OTHER

No smoking for 5-days in confinement.

Interventions

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Treatment with JUUL 5%, Virginia Tobacco

JUUL 5%, ENDS for 5-days in confinement

Intervention Type OTHER

Treatment with JUUL 5%, Cool Mint, ENDS

JUUL 5%, ENDS for 5-days in confinement

Intervention Type OTHER

Treatment with JUUL 5%, Mango, ENDS

JUUL 5%, ENDS for 5-days in confinement

Intervention Type OTHER

JUUL 5%, Creme Bruele, ENDS

JUUL 5%, ENDS for 5-days in confinement

Intervention Type OTHER

Combustible cigarette

Exclusive use of combustible cigarette for 5 days in confinement.

Intervention Type OTHER

Smoking Cessation

No smoking for 5-days in confinement.

Intervention Type OTHER

Other Intervention Names

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JUUL JUUL JUUL JUUL

Eligibility Criteria

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Inclusion Criteria

1. Healthy, adult, male or female smoker, 21 to 65 years of age.
2. Has been a smoker for at least 12 months prior to Screening.
3. Currently smokes an average of 10 cigarettes each day.
4. Has a positive urine cotinine (≥ 500 ng/mL).
5. Has an exhaled carbon monoxide (CO) \> 12 ppm.
6. A female subject of childbearing potential must have been using contraception and agree to continue using it through completion of the study:
7. Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF).

Exclusion Criteria

1. Has a history or presence of clinically significant conditions.
2. Has a body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screen
3. Has a history of drug or alcohol abuse
4. Has an estimated creatinine clearance \< 80 mL/minute
5. If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.
6. Has used nicotine-containing products other than manufactured cigarettes within 14days of screening.
7. Is planning to quit smoking during the study, planning to quit within 3 months following Day 1

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes