SmokingNCT02185898
Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes
A study testing Leading U.S. non-menthol cigarette, Leading U.S. menthol cigarette and Electronic cigarette #1 in people with Smoking, run by R.J. Reynolds Vapor Company at 1 site in United States.
Trial summary
This study will assess environmental emissions of selected compounds in a test chamber after cigarette smoking or e-cigarette vaping. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Leading U.S. non-menthol cigarette, Leading U.S. menthol cigarette and Electronic cigarette #1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2015
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy males or females, 21 years of age or older at Screening.
- Able to meet cohort-specific requirements as follows:
- Cohort 1 - Leading U.S. tobacco-burning non-menthol cigarette, and
- Cohort 2 - Leading U.S. tobacco-burning menthol cigarette:
- self-reports at the Screening Visit smoking at least 5 cigarettes per day and inhaling the smoke, for at least 3 months prior to Screening
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- self-reports smoking Leading U.S. tobacco-burning non-menthol cigarette or Leading U.S. tobacco-burning menthol cigarette as usual brand (UB) cigarettes [UB cigarette is defined as the cigarette brand style currently smoked most frequently by the participant];
- Cohort 3 - Electronic cigarette #1 smokers, and
- Cohort 4 - Electronic cigarette #2 smokers:
- self-reports at the Screening Visit smoking a non-menthol e-cigarette at least once per day, for at least 3 months prior to Screening;
- willing to switch from using their current e-cigarette brand style to using a different e-cigarette brand style during the study;
- Cohort 5 - Electronic cigarette #3 smokers:
- self-reports at the Screening Visit smoking a menthol e-cigarette at least once per day, for at least 3 months prior to Screening;
- willing to switch from using their current e-cigarette brand style to using a different e-cigarette brand style during the study;
- Cohort 6 - U.S Market-sample electronic cigarette smokers:
- self-reports at the Screening Visit smoking the selected U.S. market-sample e-cigarettes (menthol or non-menthol) at least once per day, for at least three months prior to Screening;
- willing to continue exclusive use of their preferred style (flavor) of e-cigarette during the study.
- Females of childbearing potential must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until study discharge or be surgically sterile for at least 90 days prior to enrollment;
- Able to safely perform the required study procedures, as determined by the Investigator.
Who cannot join
- Clinically significant or unstable/uncontrolled acute or chronic medical conditions at Screening, as determined by the Investigator, that would preclude a participant from participating safely in the study (e.g., hypertension, asthma, or other lung disease; cardiac disease; neurological disease; or psychiatric disorders) based on screening assessments such as safety labs and medical history or physical examination at Enrollment;
- Self-reports or safety labs indicate diabetes;
- At risk for heart disease, as determined by the Investigator;
- Use of medicine for treatment of depression or asthma;
- Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥95 mmHg, measured after being seated for 5 minutes;
- Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening Visit) to participate in this study;
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- Employed by a tobacco company, the study site, or environmental test chamber vendor;
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study;
- History of claustrophobia;
- Regularly exposed to solvent fumes or gasoline (e.g., painter, gas-station mini mart employee);
- Determined by the Investigator to be inappropriate for this study, including a participant who is unable to communicate or unwilling to cooperate with the clinical staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
Official title: A Single-Center Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes
This study will assess environmental emissions of selected compounds in a test chamber after cigarette smoking or e-cigarette vaping.
Read the detailed description
Secondhand smoke is the aged and diluted combination of smoke exhaled by a smoker and sidestream smoke (smoke from the lit end of a cigarette). Electronic cigarettes are different from tobacco-burning cigarettes in that they produce vapor, not smoke. For consistency with common usage, secondhand smoke (SHS) refers to true secondhand smoke from cigarettes and secondhand vapor from e-cigarettes.
The goals of this study are to 1) increase understanding of the composition of SHS from e-cigarettes, 2) quantitatively compare the amount of SHS generated by e-cigarettes and a market sample of commercial e-cigarettes to leading brand styles of commercial tobacco-burning cigarettes, and 3) quantitate the emission factors of e-cigarettes including the market-sample e-cigarettes.
- Conditions
- Smoking
- Being tested
- Leading U.S. non-menthol cigarette, Leading U.S. menthol cigarette, Electronic cigarette #1, Electronic cigarette #2, Electronic cigarette #3
- Keywords
- electronic cigarettes, e-cigarettes, combustible cigarettes, second-hand smoke, environmental tobacco smoke, tobacco-burning
- Medical subject headings
- Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leading U.S. non-menthol cigaretteOther
Also called Marlboro Gold Pack Box
Tobacco-burning non-menthol cigarette
Leading U.S. menthol cigaretteOther
Also called Newport Box
Tobacco-burning menthol cigarette
Electronic cigarette #1Other
Also called VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine)
Electronic cigarette
Electronic cigarette #2Other
Also called VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)
Electronic cigarette
Electronic cigarette #3Other
Also called VUSE® Digital Vapor Cigarette (original flavor, 14 mg nicotine)
Electronic cigarette
U.S. Market-sample electronic cigarettesOther
Also called blu™ (any variety) and NJOY® (any variety)
Marketed electronic cigarettes
| Study group | Role | What they receive |
|---|---|---|
| Leading U.S. tobacco-burning non-menthol cigarette | Active comparator | Leading U.S. non-menthol cigarette Receives: Other: Leading U.S. non-menthol cigarette |
| Leading U.S. tobacco-burning menthol cigarette | Active comparator | Leading U.S. menthol cigarette Receives: Other: Leading U.S. menthol cigarette |
| Electronic cigarette #1 | Experimental | VUSE® (menthol flavor, 29 mg nicotine) Receives: Other: Electronic cigarette #1 |
| Electronic cigarette #2 | Experimental | VUSE® (original flavor, 29 mg nicotine) Receives: Other: Electronic cigarette #2 |
| Electronic cigarette #3 | Experimental | VUSE® (original flavor, 14 mg nicotine) Receives: Other: Electronic cigarette #3 |
| U.S. Market-sample electronic cigarettes (two brands) | Experimental | blu™ (any variety) and NJOY® (any variety) Receives: Other: U.S. Market-sample electronic cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarette #1, #2, and #3 compared to after human smoking of tobacco-burning cigarettes.
Measured: 2 weeks for participants in Cohorts 1 and 2; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
Secondary outcomes (3)
To determine selected SHS constituent emission factors for each tobacco-burning cigarette, each e-cigarette, and the market-sample e-cigarettes (collectively).
Measured: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
To assess the differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes and tobacco-burning cigarettes compared to after a non-smoking blank condition.
Measured: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
To assess differences in levels of additional selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes compared to after human smoking of tobacco-burning cigarettes.
Measured: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- R.J. Reynolds Vapor Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance, R.J. Reynolds Tobacco Company, MAS (Materials Analytical Services), LLC
- Responsible party
- Sponsor
- Investigators
- Nathan Segall, MD, CPI, Principal investigator, Clinical Research Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185898
- Sponsor's protocol ID
- CSD1302
- Status last verified
- May 2018
- First submitted
- 7 Jul 2014
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes
- ClinicalTrials.gov ID
- NCT02185898
- Acronym / sponsor ID
- CSD1302
- Conditions
- Smoking
- Keywords
- electronic cigarettes, e-cigarettes, combustible cigarettes, second-hand smoke, environmental tobacco smoke, tobacco-burning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- R.J. Reynolds Vapor CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Covance, R.J. Reynolds Tobacco Company, MAS (Materials Analytical Services), LLC
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- 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.
This study will assess environmental emissions of selected compounds in a test chamber after cigarette smoking or e-cigarette vaping.
Detailed description
Secondhand smoke is the aged and diluted combination of smoke exhaled by a smoker and sidestream smoke (smoke from the lit end of a cigarette). Electronic cigarettes are different from tobacco-burning cigarettes in that they produce vapor, not smoke. For consistency with common usage, secondhand smoke (SHS) refers to true secondhand smoke from cigarettes and secondhand vapor from e-cigarettes.
The goals of this study are to 1) increase understanding of the composition of SHS from e-cigarettes, 2) quantitatively compare the amount of SHS generated by e-cigarettes and a market sample of commercial e-cigarettes to leading brand styles of commercial tobacco-burning cigarettes, and 3) quantitate the emission factors of e-cigarettes including the market-sample e-cigarettes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Leading U.S. tobacco-burning non-menthol cigarette | Active comparator | Other: Leading U.S. non-menthol cigaretteLeading U.S. non-menthol cigarette |
| Leading U.S. tobacco-burning menthol cigarette | Active comparator | Other: Leading U.S. menthol cigaretteLeading U.S. menthol cigarette |
| Electronic cigarette #1 | Experimental | Other: Electronic cigarette #1VUSE® (menthol flavor, 29 mg nicotine) |
| Electronic cigarette #2 | Experimental | Other: Electronic cigarette #2VUSE® (original flavor, 29 mg nicotine) |
| Electronic cigarette #3 | Experimental | Other: Electronic cigarette #3VUSE® (original flavor, 14 mg nicotine) |
| U.S. Market-sample electronic cigarettes (two brands) | Experimental | Other: U.S. Market-sample electronic cigarettesblu™ (any variety) and NJOY® (any variety) |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy males or females, 21 years of age or older at Screening.
- Able to meet cohort-specific requirements as follows:
- Cohort 1 - Leading U.S. tobacco-burning non-menthol cigarette, and
- Cohort 3 - Electronic cigarette #1 smokers, and
Key exclusion criteria (11 listed)
- Clinically significant or unstable/uncontrolled acute or chronic medical conditions at Screening, as determined by the Investigator, that would preclude a participant from participating safely in the study (e.g., hypertension, asthma, or other lung disease; cardiac disease; neurological disease; or psychiatric disorders) based on screening assessments such as safety labs and medical history or physical examination at Enrollment;
- Self-reports or safety labs indicate diabetes;
- At risk for heart disease, as determined by the Investigator;
- Use of medicine for treatment of depression or asthma;
- Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥95 mmHg, measured after being seated for 5 minutes;
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 |
|---|---|---|
| Leading U.S. non-menthol cigaretteAlso: Marlboro Gold Pack BoxTobacco-burning non-menthol cigarette | Other | Leading U.S. tobacco-burning non-menthol cigarette |
| Leading U.S. menthol cigaretteAlso: Newport BoxTobacco-burning menthol cigarette | Other | Leading U.S. tobacco-burning menthol cigarette |
| Electronic cigarette #1Also: VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine)Electronic cigarette | Other | Electronic cigarette #1 |
| Electronic cigarette #2Also: VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)Electronic cigarette | Other | Electronic cigarette #2 |
| Electronic cigarette #3Also: VUSE® Digital Vapor Cigarette (original flavor, 14 mg nicotine)Electronic cigarette | Other | Electronic cigarette #3 |
| U.S. Market-sample electronic cigarettesAlso: blu™ (any variety) and NJOY® (any variety)Marketed electronic cigarettes | Other | U.S. Market-sample electronic cigarettes (two brands) |
Primary outcome
To assess differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarette #1, #2, and #3 compared to after human smoking of tobacco-burning cigarettes.
Time frame: 2 weeks for participants in Cohorts 1 and 2; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
3 secondary outcomes
To determine selected SHS constituent emission factors for each tobacco-burning cigarette, each e-cigarette, and the market-sample e-cigarettes (collectively).
Time frame: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
To assess the differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes and tobacco-burning cigarettes compared to after a non-smoking blank condition.
Time frame: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
To assess differences in levels of additional selected SHS constituents in an environmental test chamber after human smoking of e-cigarettes compared to after human smoking of tobacco-burning cigarettes.
Time frame: 2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
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 1 Jun 2018.
- 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.
Nathan Segall, MD, CPI principal investigator
Clinical Research Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leading U.S. non-menthol cigarette, Leading U.S. menthol cigarette and Electronic cigarette #1 in people with Smoking, run by R.J. Reynolds Vapor Company at 1 site in United States.
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 19 inclusion and 11 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 1 Jun 2018. 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 United States. 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?
To assess differences in levels of selected SHS constituents in an environmental test chamber after human smoking of e-cigarette #1, #2, and #3 compared to after human smoking of tobacco-burning cigarettes. (time frame: 2 weeks for participants in Cohorts 1 and 2; and approximately 4 weeks for participants in Cohorts 3, 4, and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2018.