Second Hand Tobacco SmokeNCT03605641
Study to Evaluate Constituents in Exhaled Breath and Room Air From Use of E-vapor Products and Conventional Cigarettes
A study testing JUUL, VUSE Solo and Conventional Cigarette in people with Second Hand Tobacco Smoke, run by Juul Labs, Inc. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Second Hand Tobacco Smoke
- What is being tested?
- JUUL, VUSE Solo and Conventional Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2018to 2 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria before being enrolled into the study. Subjects must:
- Be informed of the nature of the study and agree to and are able to read, review, and sign the informed consent document (in English) prior to the first study procedure. The Investigator must be satisfied that the volunteer has the ability to read and communicate in English in order to participate in the study.
- Subjects screened as a part of an IRB-approved General Screening Protocol at the CRO site may be included in this study without additional Screening procedures provided all the required Screening procedures have been performed within 60 days prior to Clinic Visit 1.
- Be a healthy male or female volunteer aged 21 - 65 years at the time of Screening Visit.
- Have a positive urine cotinine result at Screening (Screening Visit) of >200 ng/ml.
- Be judged by the Investigator to be in good general health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the Investigator and judged to be not clinically significant for study participation.
- Agree to abide by the study restrictions and return for the required assessments.
- Have a self-reported daily conventional cigarette consumption rate of a minimum of 10 cigarettes per day for a minimum of 3 months prior to Screening Visit.
Who cannot join
- Subjects who meet any of the following exclusion criteria will not be enrolled in the study.
- Subjects must not:
- Report receiving any investigational product within 30 days prior to Screening (Screening Visit).
- Report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, oncologic or neurologic system(s) or psychiatric disease as determined by the Investigator.
- Have any clinically significant results from laboratory tests, physical examinations, vital signs assessments, and electrocardiograms, as judged by the Investigator.
- Report a clinically significant illness during the 30 days prior to enrollment, as determined by the Investigator.
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- Report a history of drug or alcohol addiction or abuse within the past 1 year.
- Have positive screen for alcohol or drugs of abuse at Screening (Screening Visit) or check-in at Clinical Visit 1.
- Have positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (anti-HCV).
- Have body mass index (BMI) greater than 40 kg/m2 or less than 18 kg/m2 at Screening (Screening Visit).
- Have used prescription anti-diabetic medication and/or insulin therapy within 12 months of Screening (Screening Visit).
- Have taken medication for depression or asthma within 6 months of Screening (Screening Visit).
- Have used prescription or over-the-counter bronchodilator medication (eg, inhaled or oral β-agonists) within 6 months of Screening (Screening Visit).
- Be breast-feeding or pregnant female subjects (confirmed by a positive pregnancy test). Female subjects, who are considered women of child bearing potential (WOCBP) and sexually active, must be willing and able to use an acceptable method of contraception from Screening (Screening Visit) through the end of the study.
- Be allergic to propylene glycol or glycerin.
- Be or have a first-degree relative (ie, parent, sibling or child) be a current employee of the Sponsor or Site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Center Clinical Trial to Evaluate Selected Constituents in the Exhaled Breath and Room Air From the Use of E-vapor Products and Conventional Cigarettes Studied Under Residential, Office and Hospitality Environmental Conditions
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.
Read the detailed description
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.
- Conditions
- Second Hand Tobacco Smoke
- Being tested
- JUUL, VUSE Solo, Conventional Cigarette
- Keywords
- E-Cigarettes, Conventional Cigarettes, JUUL, VUSE
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUULOther
JUUL Virginia Tobacco
VUSE SoloOther
VUSE SOLO Original
Conventional CigaretteOther
Subject preferred conventional cigarette
| Study group | Role | What they receive |
|---|---|---|
| JUUL electronic cigarette | Experimental | JUUL electronic cigarette. Virginia Tobacco 5% tobacco-derived nicotine. Receives: Other: JUUL |
| VUSE Solo electronic cigarette | Active comparator | Reynolds American International VUSE Solo electronic cigarette. Original flavor 4.8% tobacco-derived nicotine. Receives: Other: VUSE Solo |
| Conventional cigarette | Active comparator | Canadian purchased, store bought (not hand-rolled) conventional full-flavored cigarettes of subjects' preference. Receives: Other: Conventional Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start17 Sep 2018
- Primary completion2 Dec 2018
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Second Hand Tobacco SmokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juul Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Responsible party
- Sponsor
- Investigators
- Peter Couroux, MD, Principal investigator, Inflamax Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605641
- Sponsor's protocol ID
- 755-00045
- Status last verified
- Dec 2018
- First submitted
- 16 Jul 2018
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bam TS, Bellew W, Berezhnova I, Jackson-Morris A, Jones A, Latif E, Molinari MA, Quan G, Singh RJ, Wisotzky M; Tobacco Control Department International Union Against Tuberculosis and Lung Disease. Position statement on electronic cigarettes or electronic nicotine delivery systems. Int J Tuberc Lung Dis. 2014 Jan;18(1):5-7. doi: 10.5588/ijtld.13.0815. No abstract available.
PubMed 24365545Schober W, Szendrei K, Matzen W, Osiander-Fuchs H, Heitmann D, Schettgen T, Jorres RA, Fromme H. Use of electronic cigarettes (e-cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette consumers. Int J Hyg Environ Health. 2014 Jul;217(6):628-37. doi: 10.1016/j.ijheh.2013.11.003. Epub 2013 Dec 6.
PubMed 24373737Schripp T, Markewitz D, Uhde E, Salthammer T. Does e-cigarette consumption cause passive vaping? Indoor Air. 2013 Feb;23(1):25-31. doi: 10.1111/j.1600-0668.2012.00792.x. Epub 2012 Jul 2.
PubMed 22672560Czogala J, Goniewicz ML, Fidelus B, Zielinska-Danch W, Travers MJ, Sobczak A. Secondhand exposure to vapors from electronic cigarettes. Nicotine Tob Res. 2014 Jun;16(6):655-62. doi: 10.1093/ntr/ntt203. Epub 2013 Dec 11.
PubMed 24336346Chang H. Research gaps related to the environmental impacts of electronic cigarettes. Tob Control. 2014 May;23 Suppl 2(Suppl 2):ii54-8. doi: 10.1136/tobaccocontrol-2013-051480.
PubMed 24732165Liu J, Liang Q, Oldham MJ, Rostami AA, Wagner KA, Gillman IG, Patel P, Savioz R, Sarkar M. Determination of Selected Chemical Levels in Room Air and on Surfaces after the Use of Cartridge- and Tank-Based E-Vapor Products or Conventional Cigarettes. Int J Environ Res Public Health. 2017 Aug 28;14(9):969. doi: 10.3390/ijerph14090969.
PubMed 28846634Hess IM, Lachireddy K, Capon A. A systematic review of the health risks from passive exposure to electronic cigarette vapour. Public Health Res Pract. 2016 Apr 15;26(2):2621617. doi: 10.17061/phrp2621617.
PubMed 27734060ANSI/ASHRAE Standard 62.1-2016. Ventilation for Acceptable Indoor Air Quality. American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Center Clinical Trial to Evaluate Selected Constituents in the Exhaled Breath and Room Air From the Use of E-vapor Products and Conventional Cigarettes Studied Under Residential, Office and Hospitality Environmental Conditions
- ClinicalTrials.gov ID
- NCT03605641
- Acronym / sponsor ID
- 755-00045
- Conditions
- Second Hand Tobacco Smoke
- Keywords
- E-Cigarettes, Conventional Cigarettes, JUUL, VUSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Juul Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Inflamax Research Incorporated
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JUUL electronic cigarette | Experimental | Other: JUULJUUL electronic cigarette. Virginia Tobacco 5% tobacco-derived nicotine. |
| VUSE Solo electronic cigarette | Active comparator | Other: VUSE SoloReynolds American International VUSE Solo electronic cigarette. Original flavor 4.8% tobacco-derived nicotine. |
| Conventional cigarette | Active comparator | Other: Conventional CigaretteCanadian purchased, store bought (not hand-rolled) conventional full-flavored cigarettes of subjects' preference. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must satisfy the following criteria before being enrolled into the study. Subjects must:
- Be informed of the nature of the study and agree to and are able to read, review, and sign the informed consent document (in English) prior to the first study procedure. The Investigator must be satisfied that the volunteer has the ability to read and communicate in English in order to participate in the study.
- Subjects screened as a part of an IRB-approved General Screening Protocol at the CRO site may be included in this study without additional Screening procedures provided all the required Screening procedures have been performed within 60 days prior to Clinic Visit 1.
- Be a healthy male or female volunteer aged 21 - 65 years at the time of Screening Visit.
- Have a positive urine cotinine result at Screening (Screening Visit) of >200 ng/ml.
Key exclusion criteria (16 listed)
- Subjects who meet any of the following exclusion criteria will not be enrolled in the study.
- Report receiving any investigational product within 30 days prior to Screening (Screening Visit).
- Report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, oncologic or neurologic system(s) or psychiatric disease as determined by the Investigator.
- Have any clinically significant results from laboratory tests, physical examinations, vital signs assessments, and electrocardiograms, as judged by the Investigator.
- Report a clinically significant illness during the 30 days prior to enrollment, as determined by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUULJUUL Virginia Tobacco | Other | JUUL electronic cigarette |
| VUSE SoloVUSE SOLO Original | Other | VUSE Solo electronic cigarette |
| Conventional CigaretteSubject preferred conventional cigarette | Other | Conventional cigarette |
Primary outcome
Exhaled Breath Sample (EBS) - Nicotine
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Absolute change from baseline in nicotine levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes.
Exhaled Breath Sample (EBS) - Propylene glycol
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Absolute change from baseline in propylene glycol levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes.
Exhaled Breath Sample (EBS) - Vegetable Glycerin
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
Absolute change from baseline in vegetable glycerin levels in the EBS of subjects who use JUUL, VUSE Solo, or conventional cigarettes.
Exhaled Breath Sample (EBS) - Carbonyls
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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.
Room Air Sample (RAS) - Nicotine
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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.
Room Air Sample (RAS) - Propylene glycol
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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.
Room Air Sample (RAS) - Vegetable Glycerin
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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.
Room Air Sample (RAS) - Carbonyls
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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.
Room Air Sample (RAS) - Volatile organic compounds
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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
Room Air Samples (RAS) - Metals
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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.
Room Air Samples (RAS) - PM2.5 Particles
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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.
Room Air Samples (RAS) - PM10 Particles
Time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Background: PubMed 24365545Bam TS, Bellew W, Berezhnova I, Jackson-Morris A, Jones A, Latif E, Molinari MA, Quan G, Singh RJ, Wisotzky M; Tobacco Control Department International Union Against Tuberculosis and Lung Disease. Position statement on electronic cigarettes or electronic nicotine delivery systems. Int J Tuberc Lung Dis. 2014 Jan;18(1):5-7. doi: 10.5588/ijtld.13.0815. No abstract available.
- Background: PubMed 24373737Schober W, Szendrei K, Matzen W, Osiander-Fuchs H, Heitmann D, Schettgen T, Jorres RA, Fromme H. Use of electronic cigarettes (e-cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette consumers. Int J Hyg Environ Health. 2014 Jul;217(6):628-37. doi: 10.1016/j.ijheh.2013.11.003. Epub 2013 Dec 6.
- Background: PubMed 22672560Schripp T, Markewitz D, Uhde E, Salthammer T. Does e-cigarette consumption cause passive vaping? Indoor Air. 2013 Feb;23(1):25-31. doi: 10.1111/j.1600-0668.2012.00792.x. Epub 2012 Jul 2.
- Background: PubMed 24336346Czogala J, Goniewicz ML, Fidelus B, Zielinska-Danch W, Travers MJ, Sobczak A. Secondhand exposure to vapors from electronic cigarettes. Nicotine Tob Res. 2014 Jun;16(6):655-62. doi: 10.1093/ntr/ntt203. Epub 2013 Dec 11.
- Background: PubMed 24732165Chang H. Research gaps related to the environmental impacts of electronic cigarettes. Tob Control. 2014 May;23 Suppl 2(Suppl 2):ii54-8. doi: 10.1136/tobaccocontrol-2013-051480.
- Background: PubMed 28846634Liu J, Liang Q, Oldham MJ, Rostami AA, Wagner KA, Gillman IG, Patel P, Savioz R, Sarkar M. Determination of Selected Chemical Levels in Room Air and on Surfaces after the Use of Cartridge- and Tank-Based E-Vapor Products or Conventional Cigarettes. Int J Environ Res Public Health. 2017 Aug 28;14(9):969. doi: 10.3390/ijerph14090969.
- Background: PubMed 27734060Hess IM, Lachireddy K, Capon A. A systematic review of the health risks from passive exposure to electronic cigarette vapour. Public Health Res Pract. 2016 Apr 15;26(2):2621617. doi: 10.17061/phrp2621617.
- BackgroundANSI/ASHRAE Standard 62.1-2016. Ventilation for Acceptable Indoor Air Quality. American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Couroux, MD principal investigator
Inflamax Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUUL, VUSE Solo and Conventional Cigarette in people with Second Hand Tobacco Smoke, run by Juul Labs, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled Breath Sample (EBS) - Nicotine (time frame: Clinic Visit (JUUL/VUSE: 2 days and 2 overnights; conventional cigarette: 1 day and 1 overnight)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605641, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.