A Single-Center Evaluation of Environmental Emissions From Electronic Cigarettes and Tobacco-Burning Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
This study will assess environmental emissions of selected compounds in a test chamber after cigarette smoking or e-cigarette vaping.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Electronic cigarette #2
VUSE® (original flavor, 29 mg nicotine)
干预措施: Electronic cigarette #2 (Other)
Leading U.S. tobacco-burning non-menthol cigarette
Leading U.S. non-menthol cigarette
干预措施: Leading U.S. non-menthol cigarette (Other)
Leading U.S. tobacco-burning menthol cigarette
Leading U.S. menthol cigarette
干预措施: Leading U.S. menthol cigarette (Other)
Electronic cigarette #1
VUSE® (menthol flavor, 29 mg nicotine)
干预措施: Electronic cigarette #1 (Other)
Electronic cigarette #3
VUSE® (original flavor, 14 mg nicotine)
干预措施: Electronic cigarette #3 (Other)
U.S. Market-sample electronic cigarettes (two brands)
blu™ (any variety) and NJOY® (any variety)
干预措施: U.S. Market-sample electronic cigarettes (Other)
结局指标
主要结局
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.
时间窗: 2 weeks for participants in Cohorts 1 and 2; and approximately 4 weeks for participants in Cohorts 3, 4, and 5
次要结局
- 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)