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Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

24. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • Pennsylvania
      • Hershey, Pennsylvania, Spojené státy, 17033
        • Penn State College of Medicine
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Zachary Bitzer, Ph.D.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Nerandomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: High Wattage/High Propylene Glycol
High temperature and high propylene glycol concentration
Jiný: 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)
Jiný: High concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Experimentální: Low Wattage/Low Propylene Glycol
Low temperature and low propylene glycol concentration
Jiný: 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)
Jiný: Low concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Experimentální: High Wattage/Low Propylene Glycol
High temperature and low propylene glycol concentration
Jiný: 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)
Jiný: Low concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Experimentální: Low Wattage/High Propylene Glycol
Low temperature and high propylene glycol concentration
Jiný: High concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Jiný: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
8-isoprostane in Exhaled Breath Condensate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
E-cigarette Puffing Behavior - Duration of Puffs
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Milton S. Hershey Medical Center

Spolupracovníci

National Institute on Drug Abuse (NIDA)

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. srpna 2028

Dokončení studie (Odhadovaný)

1. prosince 2028

Termíny zápisu do studia

První předloženo

13. května 2026

První předloženo, které splnilo kritéria kontroly kvality

24. května 2026

První zveřejněno (Aktuální)

29. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • STUDY00028240
  • U54DA058271 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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