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

NCT02185898 | Completed

• 1 other identifier: CSD1302
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking

Keywords

electronic cigarettes; e-cigarettes; combustible cigarettes; second-hand smoke; environmental tobacco smoke; tobacco-burning

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  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.

  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.

  2 weeks for participants in Cohorts 1, 2, and 6; and approximately 4 weeks for participants in Cohorts 3, 4, and 5

Study Arms (6)

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

ACTIVE COMPARATOR

Leading U.S. non-menthol cigarette

Other: Leading U.S. non-menthol cigarette

Leading U.S. tobacco-burning menthol cigarette

ACTIVE COMPARATOR

Leading U.S. menthol cigarette

Other: Leading U.S. menthol cigarette

Electronic cigarette #1

EXPERIMENTAL

VUSE® (menthol flavor, 29 mg nicotine)

Other: Electronic cigarette #1

Electronic cigarette #2

EXPERIMENTAL

VUSE® (original flavor, 29 mg nicotine)

Other: Electronic cigarette #2

Electronic cigarette #3

EXPERIMENTAL

VUSE® (original flavor, 14 mg nicotine)

Other: Electronic cigarette #3

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

EXPERIMENTAL

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

Other: U.S. Market-sample electronic cigarettes

Interventions

Leading U.S. non-menthol cigarette OTHER

Tobacco-burning non-menthol cigarette

Also known as: Marlboro Gold Pack Box

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

Leading U.S. menthol cigarette OTHER

Tobacco-burning menthol cigarette

Also known as: Newport Box

Leading U.S. tobacco-burning menthol cigarette

Electronic cigarette #1 OTHER

Electronic cigarette

Also known as: VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine)

Electronic cigarette #1

Electronic cigarette #2 OTHER

Electronic cigarette

Also known as: VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)

Electronic cigarette #2

Electronic cigarette #3 OTHER

Electronic cigarette

Also known as: VUSE® Digital Vapor Cigarette (original flavor, 14 mg nicotine)

Electronic cigarette #3

U.S. Market-sample electronic cigarettes OTHER

Marketed electronic cigarettes

Also known as: blu™ (any variety) and NJOY® (any variety)

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

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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.

Sponsors & Collaborators

• R.J. Reynolds Vapor Company: lead
• Covance: collaborator
• R.J. Reynolds Tobacco Company: collaborator
• MAS (Materials Analytical Services), LLC: collaborator

Study Sites (1)

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

MeSH Terms

Conditions

Smoking; Vaping

Interventions

Menthol; Nicotine; UBE2N protein, human

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nathan Segall, MD, CPI

  Clinical Research Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)