Status:
COMPLETED
Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes
Lead Sponsor:
R.J. Reynolds Vapor Company
Collaborating Sponsors:
Covance
R.J. Reynolds Tobacco Company
Conditions:
Smoking
Eligibility:
All Genders
21-99 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02185898
Start Date
May 1 2014
End Date
February 1 2015
Last Update
June 1 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281