Status:
COMPLETED
Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
Lead Sponsor:
Juul Labs, Inc.
Collaborating Sponsors:
Celerion
Conditions:
Nicotine Dependence, Other Tobacco Product
Tobacco Use
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
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 healt...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03463837
Start Date
March 4 2018
End Date
August 13 2018
Last Update
June 21 2021
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68516