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

NCT ID: NCT02185898

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-02-28

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 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Leading U.S. tobacco-burning non-menthol cigarette

Leading U.S. non-menthol cigarette

Group Type: ACTIVE_COMPARATOR

Leading U.S. non-menthol cigarette

Intervention Type: OTHER

Tobacco-burning non-menthol cigarette

Leading U.S. tobacco-burning menthol cigarette

Leading U.S. menthol cigarette

Group Type: ACTIVE_COMPARATOR

Leading U.S. menthol cigarette

Intervention Type: OTHER

Tobacco-burning menthol cigarette

Electronic cigarette #1

VUSE® (menthol flavor, 29 mg nicotine)

Group Type: EXPERIMENTAL

Electronic cigarette #1

Intervention Type: OTHER

Electronic cigarette

Electronic cigarette #2

VUSE® (original flavor, 29 mg nicotine)

Group Type: EXPERIMENTAL

Electronic cigarette #2

Intervention Type: OTHER

Electronic cigarette

Electronic cigarette #3

VUSE® (original flavor, 14 mg nicotine)

Group Type: EXPERIMENTAL

Electronic cigarette #3

Intervention Type: OTHER

Electronic cigarette

U.S. Market-sample electronic cigarettes (two brands)

blu™ (any variety) and NJOY® (any variety)

Group Type: EXPERIMENTAL

U.S. Market-sample electronic cigarettes

Intervention Type: OTHER

Marketed electronic cigarettes

Interventions

Leading U.S. non-menthol cigarette

Tobacco-burning non-menthol cigarette

Intervention Type: OTHER

Leading U.S. menthol cigarette

Tobacco-burning menthol cigarette

Intervention Type: OTHER

Electronic cigarette #1

Electronic cigarette

Intervention Type: OTHER

Electronic cigarette #2

Electronic cigarette

Intervention Type: OTHER

Electronic cigarette #3

Electronic cigarette

Intervention Type: OTHER

U.S. Market-sample electronic cigarettes

Marketed electronic cigarettes

Intervention Type: OTHER

Other Intervention Names

Marlboro Gold Pack Box; Newport Box; VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine); VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine); VUSE® Digital Vapor Cigarette (original flavor, 14 mg nicotine); blu™ (any variety) and NJOY® (any variety)

Eligibility Criteria

Inclusion Criteria

1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.

2. Generally healthy males or females, 21 years of age or older at Screening.

3. 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.

4. 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;

5. Able to safely perform the required study procedures, as determined by the Investigator.

Exclusion Criteria

1. 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;

2. Self-reports or safety labs indicate diabetes;

3. At risk for heart disease, as determined by the Investigator;

4. Use of medicine for treatment of depression or asthma;

5. Systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥95 mmHg, measured after being seated for 5 minutes;

6. Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening Visit) to participate in this study;

7. Employed by a tobacco company, the study site, or environmental test chamber vendor;

8. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study;

9. History of claustrophobia;

10. Regularly exposed to solvent fumes or gasoline (e.g., painter, gas-station mini mart employee);

11. 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

R.J. Reynolds Tobacco Company

INDUSTRY

Sponsor Role: collaborator

MAS (Materials Analytical Services), LLC

OTHER

Sponsor Role: collaborator

R.J. Reynolds Vapor Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan Segall, MD, CPI

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Atlanta

Locations

Clinical Research Atlanta

Stockbridge, Georgia, United States

Countries

United States

Other Identifiers

CSD1302

Identifier Type: -

Identifier Source: org_study_id