An open-label, single center, three-arm observational study to examine emissions from e-cigarettes versus conventional cigarettes under three environmental settings of typical residential, office and hospitality facilities.
Specific constituents will be measured in exhaled breath samples (EBS) from adult e-vapor product users and smokers when they are using e-vapor products or smoking conventional cigarettes. These constituents and particle counts (PC), will be measured in the room air samples (RAS) collected in the environmental exposure chamber (EEC) where adult e-cigarette users and smokers are using electronic cigarettes or smoking conventional cigarettes. All subjects will undergo a Screening Visit to assess if they meet study eligibility criteria. If all eligibility criteria are met and the subject signs informed consent, the subject will be assigned to one of three groups: Group I (JUUL), Group II (VUSE Solo), or Group III (Conventional Cigarettes). All three Groups will be sequentially observed in environmental settings 1 (residential), 2 (office), and 3 (hospitality). The observation period allocated for each environmental setting will be 2-days and 2-overnights for Groups I and II, and 1-day and 1-overnight for Group III. Each observation period will be referred to as a "Clinic Visit". Subjects will move on to subsequent Environment Settings (Clinic Visits 2 or 3) after completion of the previous Clinic Visit (1 or 2). Subjects must return to the clinic for Clinic Visit 1 within 60 days of the Screening Visit. Clinic Visit 2 must occur 7 ± 2 days after the Clinic Visit 1, and Clinic Visit 3 must occur 7 ± 2 days after Clinic Visit 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
43
Inflamax Research Limited
Mississauga, Ontario, Canada
Exhaled Breath Sample (EBS) - Nicotine
Absolute change from baseline in nicotine levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Exhaled Breath Sample (EBS) - Propylene glycol
Absolute change from baseline in propylene glycol levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Exhaled Breath Sample (EBS) - Vegetable Glycerin
Absolute change from baseline in vegetable glycerin levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Exhaled Breath Sample (EBS) - Carbonyls
Absolute change from baseline in carbonyl levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes. Carbonyl compounds include: formaldehyde, acetaldehyde, and acrolein.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Room Air Sample (RAS) - Nicotine
Absolute change from baseline in nicotine levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Room Air Sample (RAS) - Propylene glycol
Absolute change from baseline in propylene glycol levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions.
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Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Room Air Sample (RAS) - Vegetable Glycerin
Absolute change from baseline in vegetable glycerin levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Room Air Sample (RAS) - Carbonyls
Absolute change from baseline in carbonyl levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. Carbonyl compounds include: formaldehyde, crotonaldehyde, o-tolualdehyde, acetaldehyde, butyraldehyde (butanal), m\&p-tolualdehyde, acetone, benzaldehyde, propionaldehyde, isovaleraldehyde, hexanaldehyde (aka hexaldehyde), valeraldehyde, 2, 5-dimethylbenzaldehyde, methyl ethyl ketone (MEK), acrolein.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Room Air Sample (RAS) - Volatile organic compounds
Absolute change from baseline in volatile organic compound levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. Volatile organic compounds include: 1,3-butadiene, Benzene, isoprene, toluene, furan, ethylene oxide, vinyl chloride, propylene oxide, nitromethane, 2-nitropropane, vinyl acetate, ethylbenzene
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Room Air Samples (RAS) - Metals
Absolute change from baseline in metal levels in the room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions. Metals include: arsenic, cadmium, chromium, nickel.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Room Air Samples (RAS) - PM2.5 Particles
Absolute change from baseline levels of PM2.5 particles in room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Room Air Samples (RAS) - PM10 Particles
Absolute change from baseline levels of PM10 particles in room air when subjects use JUUL or VUSE Solo over 4-hour prescribed conditions and JUUL, VUSE Solo, or conventional cigarettes over 4-hour ad libitum conditions.
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)