Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This project seeks to determine how e-cigarette (EC) physical design features, including those that allow the user to manipulate the quality and quantity of aerosols, affect exposure and toxicity from oxidants and other aerosol constituents.
详细描述
Subjects will be provided with a study e-cigarette and e-liquid to use during the duration of the study. They will be asked to complete various questionaries as well as provide blood, exhaled breath, exhaled breath condensate, saliva and buccal cell samples.
Their puffing behavior and biomarkers of tobacco exposure and harm will be measured as follows:
E-cigarette (EC) puffing behavior - In order to determine a measurement of toxicant dose, topography markers such as puff duration, number of puffs, and interpuff interval (IPI) will be assessed via video recorded sessions.
E-liquid consumption will be assessed by weighing the filled tanks before and after the session.
Subjective effects such as nicotine withdrawal symptoms, urge to vape, and positive/negative effects will be assessed by questionnaires during the human lab studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older
- •Normal pulmonary and cardiovascular function with no history of COPD or cardiovascular disease (excluding hypertension)
- •Current exclusive use of a sub-ohm/mod or pod EC devices (≥ 1mL e-liquid/per day, ≥6 mg/ml nicotine concentration, EC for ≥ 1 year)
- •No plan on quitting nicotine use over the course of the study
- •All other forms of nicotine must be used <5 days out of the past 28 days.
- •Able to read and write in English
- •Have access to email and a smartphone/computer that has reliable internet connection
排除标准
- •Women who are pregnant and/or nursing or trying to become pregnant
- •Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)
- •Respiratory diseases (e.g., exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data
- •Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months
- •Have immediate family or household members currently participating in this trial
研究组 & 干预措施
High Wattage/Low Propylene Glycol
High temperature and low propylene glycol concentration
干预措施: Low concentration of Propylene Glycol (Other)
Low Wattage/High Propylene Glycol
Low temperature and high propylene glycol concentration
干预措施: Low temperature wattage setting on electronic cigarette (Other)
Low Wattage/High Propylene Glycol
Low temperature and high propylene glycol concentration
干预措施: High concentration of Propylene Glycol (Other)
High Wattage/Low Propylene Glycol
High temperature and low propylene glycol concentration
干预措施: High temperature wattage setting on electronic cigarette (Other)
Low Wattage/Low Propylene Glycol
Low temperature and low propylene glycol concentration
干预措施: Low concentration of Propylene Glycol (Other)
High Wattage/High Propylene Glycol
High temperature and high propylene glycol concentration
干预措施: High concentration of Propylene Glycol (Other)
High Wattage/High Propylene Glycol
High temperature and high propylene glycol concentration
干预措施: High temperature wattage setting on electronic cigarette (Other)
Low Wattage/Low Propylene Glycol
Low temperature and low propylene glycol concentration
干预措施: Low temperature wattage setting on electronic cigarette (Other)
研究者
Zachary Bitzer
Assistant Professor, Department of Public Health Sciences
Milton S. Hershey Medical Center