An interventional study of High temperature wattage setting on electronic cigarette and Low temperature wattage setting on electronic cigarette in Oxidative Stress, Tobacco Use and Electronic Cigarettes, sponsored by Milton S. Hershey Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Basic science
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.
420 studies on the registry are indexed under Tobacco Use; 82 are open to participants now.
This study's planned enrollment of 50 is below the median of 124 across 351 interventional studies indexed under Tobacco Use.
Browse Tobacco Use studies →Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High temperature and high propylene glycol concentration
Other: High temperature wattage setting on electronic cigarette · Other: High concentration of Propylene Glycol
Low temperature and low propylene glycol concentration
Other: Low temperature wattage setting on electronic cigarette · Other: Low concentration of Propylene Glycol
High temperature and low propylene glycol concentration
Other: High temperature wattage setting on electronic cigarette · Other: Low concentration of Propylene Glycol
Low temperature and high propylene glycol concentration
Other: Low temperature wattage setting on electronic cigarette · Other: High concentration of Propylene Glycol
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%)
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
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
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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