Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers (Diamond)

Juul Labs

Status: Completed

Conditions: Smoking, Tobacco; Nicotine Dependence, Other Tobacco Product; Tobacco Use

Treatments: Other: JUUL 5%, Creme Bruele, ENDS; Other: Smoking Cessation; Other: Treatment with JUUL 5%, Cool Mint, ENDS; Other: Treatment with JUUL 5%, Virginia Tobacco; Other: Combustible cigarette; Other: Treatment with JUUL 5%, Mango, ENDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03463837

755-00041

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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).

Key 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 6 patient groups

Treatment with JUUL 5%, Virginia Tobacco

Experimental group

Description:

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

Treatment:

Other: Treatment with JUUL 5%, Virginia Tobacco

Treatment with JUUL 5%, Cool Mint, ENDS

Experimental group

Description:

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

Treatment:

Other: Treatment with JUUL 5%, Cool Mint, ENDS

Treatment with JUUL 5%, Mango, ENDS

Experimental group

Description:

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

Treatment:

Other: Treatment with JUUL 5%, Mango, ENDS

JUUL 5%, Creme Bruele, ENDS

Experimental group

Description:

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

Treatment:

Other: JUUL 5%, Creme Bruele, ENDS

Combustible cigarette

Active Comparator group

Description:

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

Treatment:

Other: Combustible cigarette

Smoking cessation (no smoking)

Sham Comparator group

Description:

Smoking cessation (no smoking).

Treatment:

Other: Smoking Cessation