- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02185898
Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes
A Single-Center Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
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Stockbridge, Georgia, United States, 30281
- Clinical Research Atlanta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Leading U.S. tobacco-burning non-menthol cigarette
Leading U.S. non-menthol cigarette
|
Tobacco-burning non-menthol cigarette
Other Names:
|
Active Comparator: Leading U.S. tobacco-burning menthol cigarette
Leading U.S. menthol cigarette
|
Tobacco-burning menthol cigarette
Other Names:
|
Experimental: Electronic cigarette #1
VUSE® (menthol flavor, 29 mg nicotine)
|
Electronic cigarette
Other Names:
|
Experimental: Electronic cigarette #2
VUSE® (original flavor, 29 mg nicotine)
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Electronic cigarette
Other Names:
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Experimental: Electronic cigarette #3
VUSE® (original flavor, 14 mg nicotine)
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Electronic cigarette
Other Names:
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Experimental: U.S. Market-sample electronic cigarettes (two brands)
blu™ (any variety) and NJOY® (any variety)
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Marketed electronic cigarettes
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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2 weeks for participants in Cohorts 1 and 2; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
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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
|
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
|
2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathan Segall, MD, CPI, Clinical Research Atlanta
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Burns
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Dermatologic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Antipruritics
- Nicotine
- Menthol
Other Study ID Numbers
- CSD1302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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