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Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

24. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Pennsylvania
      • Hershey, Pennsylvania, Vereinigte Staaten, 17033
        • Penn State College of Medicine
        • Kontakt:
        • Hauptermittler:
          • Zachary Bitzer, Ph.D.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: High Wattage/High Propylene Glycol
High temperature and high propylene glycol concentration
Sonstiges: 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)
Sonstiges: High concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Experimental: Low Wattage/Low Propylene Glycol
Low temperature and low propylene glycol concentration
Sonstiges: 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)
Sonstiges: Low concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Experimental: High Wattage/Low Propylene Glycol
High temperature and low propylene glycol concentration
Sonstiges: 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)
Sonstiges: Low concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Experimental: Low Wattage/High Propylene Glycol
Low temperature and high propylene glycol concentration
Sonstiges: High concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Sonstiges: 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)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
8-isoprostane in Exhaled Breath Condensate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
E-cigarette Puffing Behavior - Duration of Puffs
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Milton S. Hershey Medical Center

Mitarbeiter

National Institute on Drug Abuse (NIDA)

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. August 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Mai 2026

Zuerst gepostet (Tatsächlich)

29. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00028240
  • U54DA058271 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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