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Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

10 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Pennsylvania
      • Hershey, Pennsylvania, Stany Zjednoczone, 17033
        • Penn State College of Medicine
        • Kontakt:
        • Główny śledczy:
          • Zachary Bitzer, Ph.D.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: High Wattage/High Propylene Glycol
High temperature and high propylene glycol concentration
Inny: 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)
Inny: High concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Eksperymentalny: Low Wattage/Low Propylene Glycol
Low temperature and low propylene glycol concentration
Inny: 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)
Inny: Low concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Eksperymentalny: High Wattage/Low Propylene Glycol
High temperature and low propylene glycol concentration
Inny: 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)
Inny: Low concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Eksperymentalny: Low Wattage/High Propylene Glycol
Low temperature and high propylene glycol concentration
Inny: High concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Inny: 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)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
8-isoprostane in Exhaled Breath Condensate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
E-cigarette Puffing Behavior - Duration of Puffs
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Milton S. Hershey Medical Center

Współpracownicy

National Institute on Drug Abuse (NIDA)

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 października 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

13 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 maja 2026

Pierwszy wysłany (Rzeczywisty)

29 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY00028240
  • U54DA058271 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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