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

This study has been completed.
Sponsor:
Collaborators:
Covance
R.J. Reynolds Tobacco Company
Materials Analytical Services, LLC
Information provided by (Responsible Party):
R.J. Reynolds Vapor Company
ClinicalTrials.gov Identifier:
NCT02185898
First received: July 7, 2014
Last updated: January 21, 2016
Last verified: January 2016
  Purpose
This study will assess environmental emissions of selected compounds in a test chamber after cigarette smoking or e-cigarette vaping.

Condition Intervention
Smoking
Other: Leading U.S. non-menthol cigarette
Other: Leading U.S. menthol cigarette
Other: Electronic cigarette #1
Other: Electronic cigarette #2
Other: Electronic cigarette #3
Other: U.S. Market-sample electronic cigarettes

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Single-Center Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes

Resource links provided by NLM:


Further study details as provided by R.J. Reynolds Vapor Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: May 2014
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Leading U.S. tobacco-burning non-menthol cigarette
Leading U.S. non-menthol cigarette
Other: Leading U.S. non-menthol cigarette
Tobacco-burning non-menthol cigarette
Other Name: Marlboro Gold Pack Box
Active Comparator: Leading U.S. tobacco-burning menthol cigarette
Leading U.S. menthol cigarette
Other: Leading U.S. menthol cigarette
Tobacco-burning menthol cigarette
Other Name: Newport Box
Experimental: Electronic cigarette #1
VUSE® (menthol flavor, 29 mg nicotine)
Other: Electronic cigarette #1
Electronic cigarette
Other Name: VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine)
Experimental: Electronic cigarette #2
VUSE® (original flavor, 29 mg nicotine)
Other: Electronic cigarette #2
Electronic cigarette
Other Name: VUSE® Digital Vapor Cigarette (original flavor, 29 mg nicotine)
Experimental: Electronic cigarette #3
VUSE® (original flavor, 14 mg nicotine)
Other: Electronic cigarette #3
Electronic cigarette
Other Name: VUSE® Digital Vapor Cigarette (original flavor, 14 mg nicotine)
Experimental: U.S. Market-sample electronic cigarettes (two brands)
blu™ (any variety) and NJOY® (any variety)
Other: U.S. Market-sample electronic cigarettes
Marketed electronic cigarettes
Other Name: blu™ (any variety) and NJOY® (any variety)

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02185898

Locations
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
Sponsors and Collaborators
R.J. Reynolds Vapor Company
Covance
R.J. Reynolds Tobacco Company
Materials Analytical Services, LLC
Investigators
Principal Investigator: Nathan Segall, MD, CPI Clinical Research Atlanta
  More Information

Responsible Party: R.J. Reynolds Vapor Company
ClinicalTrials.gov Identifier: NCT02185898     History of Changes
Other Study ID Numbers: CSD1302 
Study First Received: July 7, 2014
Last Updated: January 21, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by R.J. Reynolds Vapor Company:
electronic cigarettes
e-cigarettes
combustible cigarettes
second-hand smoke
environmental tobacco smoke
tobacco-burning

Additional relevant MeSH terms:
Menthol
Nicotine
Antipruritics
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Dermatologic Agents
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016