Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes

Completed · Not applicable

Conditions studied: Smoking

In brief

This study will assess environmental emissions of selected compounds in a test chamber after cigarette smoking or e-cigarette vaping.

Key facts

Study ID

NCT02185898

Run by

R.J. Reynolds Vapor Company

People needed

71

Starts

2014-05-01

Expected to finish

2015-02-01

Last updated by the study team

2018-06-01

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Atlanta — Stockbridge, Georgia, United States

Full record on ClinicalTrials.gov

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