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Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

10 september 2026 bijgewerkt door: Zachary Bitzer, Milton S. Hershey Medical Center

Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Hershey, Pennsylvania, Verenigde Staten, 17033
        • Penn State College of Medicine
        • Contact:
        • Hoofdonderzoeker:
          • Zachary Bitzer, Ph.D.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: High Wattage/High Propylene Glycol
High temperature and high propylene glycol concentration
Ander: High temperature wattage setting on electronic cigarette
Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)
Ander: High concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Experimenteel: Low Wattage/Low Propylene Glycol
Low temperature and low propylene glycol concentration
Ander: Low temperature wattage setting on electronic cigarette
Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)
Ander: Low concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Experimenteel: High Wattage/Low Propylene Glycol
High temperature and low propylene glycol concentration
Ander: High temperature wattage setting on electronic cigarette
Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)
Ander: Low concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Experimenteel: Low Wattage/High Propylene Glycol
Low temperature and high propylene glycol concentration
Ander: High concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Ander: Low temperature wattage setting on electronic cigarette
Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
8-isoprostane in Exhaled Breath Condensate
Tijdsspanne: Baseline prior to study product use in Phase 1
8-isoprostane levels will be analyzed via LC-MS
Baseline prior to study product use in Phase 1
8-isoprostane in Exhaled Breath Condensate
Tijdsspanne: 5 minutes after directed study product use in Phase 1
8-isoprostane levels will be analyzed via LC-MS
5 minutes after directed study product use in Phase 1
8-isoprostane in Exhaled Breath Condensate
Tijdsspanne: 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
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
Tijdsspanne: 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
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
Tijdsspanne: Baseline prior to study product use in Phase 1
8-OHdG-DNA adducts will be measured via LC-MS/MS
Baseline prior to study product use in Phase 1
8-OHdG DNA Adducts in Buccal Cells
Tijdsspanne: 5 minutes after directed study product use in Phase 1
8-OHdG-DNA adducts will be measured via LC-MS/MS
5 minutes after directed study product use in Phase 1
8-OHdG DNA Adducts in Buccal Cells
Tijdsspanne: 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
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
Tijdsspanne: 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
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
Tijdsspanne: Baseline prior to study product use in Phase 1
Nicotine levels will analyzed via LC-MS
Baseline prior to study product use in Phase 1
Total nicotine in Blood Samples
Tijdsspanne: 5 minute after directed study product use in Phase 1
Nicotine level will be analyzed via LC-MS
5 minute after directed study product use in Phase 1
Total nicotine in Blood Samples
Tijdsspanne: 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
Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
Total nicotine in Blood Samples
Tijdsspanne: 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
5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
E-cigarette Puffing Behavior - Duration of Puffs
Tijdsspanne: 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.
5 minutes of directed study product laboratory use in Phase 1
E-cigarette Puffing Behavior - Duration of Puffs
Tijdsspanne: 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.
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
Tijdsspanne: 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.
5 minutes of directed study product laboratory use in Phase 1.
E-cigarette Puffing Behavior - Number of Puffs
Tijdsspanne: 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.
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
Tijdsspanne: 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.
5 minutes of directed study product laboratory use in Phase 1
E-cigarette Puffing Behavior - Interpuff Interval
Tijdsspanne: 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.
5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Milton S. Hershey Medical Center

Medewerkers

National Institute on Drug Abuse (NIDA)

Onderzoekers

  • Hoofdonderzoeker: Zachary Bitzer, Ph.D., Penn State Hershey College of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 oktober 2026

Primaire voltooiing (Geschat)

1 augustus 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

13 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

10 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00028240
  • U54DA058271 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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