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.
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. The total nicotine delivered and GSH oxidation will be calculated in blood via LC-MS. Exhaled breath condensate (EBC) samples will be analyzed by Liquid Chromatography/Mass Spectroscopy (LC/MS) and include the primary biomarker of oxidative stress (8-isoprostane) and a series of proinflammatory cytokines (IL-6 and hsCRP). Exfoliated buccal mucosal cells will be analyzed for 8-OHdG-DNA adducts by LC-MS/MS as a biomarker of oral oxidant exposure/damage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
50
Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)
Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Penn State College of Medicine
Hershey, Pennsylvania, United States
8-isoprostane in Exhaled Breath Condensate
8-isoprostane levels will be analyzed via LC-MS
Time frame: Baseline prior to study product use in Phase 1
8-isoprostane in Exhaled Breath Condensate
8-isoprostane levels will be analyzed via LC-MS
Time frame: 5 minutes after directed study product use in Phase 1
8-isoprostane in Exhaled Breath Condensate
8-isoprostane levels will be analyzed via LC-MS
Time frame: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
8-isoprostane in Exhaled Breath Condensate
8-isoprostane levels will be analyzed via LC-MS
Time frame: 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
8-OHdG DNA Adducts in Buccal Cells
8-OHdG-DNA adducts will be measured via LC-MS/MS
Time frame: Baseline prior to study product use in Phase 1
8-OHdG DNA Adducts in Buccal Cells
8-OHdG-DNA adducts will be measured via LC-MS/MS
Time frame: 5 minutes after directed study product use in Phase 1
8-OHdG DNA Adducts in Buccal Cells
8-OHdG-DNA adducts will be measured via LC-MS/MS
Time frame: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
8-OHdG DNA Adducts in Buccal Cells
8-OHdG-DNA adducts will be measured via LC-MS/MS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Time frame: 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
Total nicotine in Blood Samples
Nicotine levels will analyzed via LC-MS
Time frame: Baseline prior to study product use in Phase 1
Total nicotine in Blood Samples
Nicotine level will be analyzed via LC-MS
Time frame: 5 minute after directed study product use in Phase 1
Total nicotine in Blood Samples
Nicotine levels will be analyzed via LC-MS
Time frame: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
Total nicotine in Blood Samples
Nicotine levels will be analyzed via LC-MS
Time frame: 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
E-cigarette Puffing Behavior - Duration of Puffs
E-cigarette puff duration will be monitored via video during the 5 minutes of laboratory product usage.
Time frame: 5 minutes of directed study product laboratory use in Phase 1
E-cigarette Puffing Behavior - Duration of Puffs
E-cigarette puff duration will be monitored via video during the 5 minutes of laboratory product usage.
Time frame: 5 minutes of directed study product laboratory use in Phase 2b; visit occurs after 2 weeks of at home product use
E-cigarette Puffing Behavior - Number of Puffs
Number of e-cigarette puffs will be monitored via video during the 5 minutes of laboratory product usage.
Time frame: 5 minutes of directed study product laboratory use in Phase 1.
E-cigarette Puffing Behavior - Number of Puffs
Number of e-cigarette puffs will be monitored via video during the 5 minutes of laboratory product usage.
Time frame: 5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
E-cigarette Puffing Behavior - Interpuff Interval
E-cigarette interpuff interval will be monitored via video during the 5 minutes of laboratory product usage.
Time frame: 5 minutes of directed study product laboratory use in Phase 1
E-cigarette Puffing Behavior - Interpuff Interval
E-cigarette interpuff interval will be monitored via video during the 5 minutes of laboratory product usage.
Time frame: 5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use