Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
Location contact
Kenneth Houser, MS
CONTACT
Zachary Bitzer, Ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07612696
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.
Trial opening soon.
Get Notified21 year and older
All sexes
Interventional
Not applicable
Hershey, Pennsylvania, 17033, United States
Kenneth Houser, MS
CONTACT
Zachary Bitzer, Ph.D.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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%)
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Time frame: Baseline prior to study product use in Phase 1
8-isoprostane levels will be analyzed via LC-MS
Time frame: 5 minutes after directed study product use in Phase 1
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 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-isoprostane levels will be analyzed via LC-MS
Time frame: Baseline prior to study product use in Phase 1
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 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 will be measured via LC-MS/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 will be measured via LC-MS/MS
Time frame: Baseline prior to study product use in Phase 1
Nicotine levels will analyzed via LC-MS
Time frame: 5 minute after directed study product use in Phase 1
Nicotine level 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
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
Nicotine levels will be analyzed via LC-MS
Time frame: 5 minutes of directed study product laboratory use in Phase 1
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 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.
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
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 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
E-cigarette interpuff interval will be monitored via video during the 5 minutes of laboratory product usage.
Contact information is provided by the study sponsor or research team.
Kenneth Houser, MS
CONTACT
Zachary Btizer, Ph. D.
CONTACT
Milton S. Hershey Medical Center
Other
Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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