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

Juul Labs, Inc.90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Nicotine Dependence, Other Tobacco Product Tobacco Use Smoking, Tobacco

Interventions

Treatment with JUUL 5%, Virginia TobaccoOTHER

JUUL 5%, ENDS for 5-days in confinement

Treatment with JUUL 5%, Cool Mint, ENDSOTHER

JUUL 5%, ENDS for 5-days in confinement

Treatment with JUUL 5%, Mango, ENDSOTHER

JUUL 5%, ENDS for 5-days in confinement

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Celerion

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Change in primary biomarkers day 5 values for each JUUL 5% product will be compared to baseline:

Change in ; Urine N nitrosonornicotine (NNN), 4 (methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), 3 hydroxypropylmercapturic acid (3-HPMA), monohydroxybutenylmercapturic acid (MHBMA), and S-phenyl mercapturic acid (S-PMA) "Blood carboxyhemoglobin (COHb)