Trial | NCT03463837  Report issue

Title

Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
A Randomized, Open-Label, Parallel-Group Study to Characterize Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Treatment with JUUL 5%, Virginia Tobacco ...

  • Study Participants

    90
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.
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.
Study Started
Mar 04
2018
Primary Completion
Jul 27
2018
Study Completion
Aug 13
2018
Last Update
Jun 21
2021

Other Treatment with JUUL 5%, Virginia Tobacco

JUUL 5%, ENDS for 5-days in confinement

  • Other names: JUUL

Other Treatment with JUUL 5%, Cool Mint, ENDS

JUUL 5%, ENDS for 5-days in confinement

  • Other names: JUUL

Other Treatment with JUUL 5%, Mango, ENDS

JUUL 5%, ENDS for 5-days in confinement

  • Other names: JUUL

Other JUUL 5%, Creme Bruele, ENDS

JUUL 5%, ENDS for 5-days in confinement

  • Other names: JUUL

Other Combustible cigarette

Exclusive use of combustible cigarette for 5 days in confinement.

Other Smoking Cessation

No smoking for 5-days in confinement.

Treatment with JUUL 5%, Virginia Tobacco Experimental

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

Treatment with JUUL 5%, Cool Mint, ENDS Experimental

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

Treatment with JUUL 5%, Mango, ENDS Experimental

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

JUUL 5%, Creme Bruele, ENDS Experimental

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

Combustible cigarette Active Comparator

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

Smoking cessation (no smoking) Sham Comparator

Smoking cessation (no smoking).

Criteria 

Key Inclusion Criteria:

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

Key Exclusion Criteria

Has a history or presence of clinically significant conditions.
Has a body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screen
Has a history of drug or alcohol abuse
Has an estimated creatinine clearance < 80 mL/minute
If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.
Has used nicotine-containing products other than manufactured cigarettes within 14days of screening.
Is planning to quit smoking during the study, planning to quit within 3 months following Day 1
No Results Posted