Impact of Electronic Cigarette Temperature and Solvent on Biomarkers
10. september 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kenneth Houser, MS
- Telefonnummer: 717-531-5473
- E-post: khouser@pennstatehealth.psu.edu
Studer Kontakt Backup
- Navn: Zachary Btizer, Ph. D.
- Telefonnummer: 717-531-4387
- E-post: zbitzer@pennstatehealth.psu.edu
Studiesteder
-
-
Pennsylvania
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Hershey, Pennsylvania, Forente stater, 17033
- Penn State College of Medicine
-
Ta kontakt med:
- Kenneth Houser, MS
- Telefonnummer: 717-531-5473
- E-post: khouser@pennstatehealth.psu.edu
-
Hovedetterforsker:
- Zachary Bitzer, Ph.D.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: High Wattage/High Propylene Glycol
High temperature and high propylene glycol concentration
|
Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
|
|
Eksperimentell: Low Wattage/Low Propylene Glycol
Low temperature and low propylene glycol concentration
|
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 (10%)
|
|
Eksperimentell: High Wattage/Low Propylene Glycol
High temperature and low propylene glycol concentration
|
Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
|
|
Eksperimentell: Low Wattage/High Propylene Glycol
Low temperature and high propylene glycol concentration
|
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
8-isoprostane in Exhaled Breath Condensate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
E-cigarette Puffing Behavior - Duration of Puffs
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Zachary Bitzer, Ph.D., Penn State Hershey College of Medicine
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
15. oktober 2026
Primær fullføring (Antatt)
1. august 2028
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
13. mai 2026
Først innsendt som oppfylte QC-kriteriene
24. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00028240
- U54DA058271 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .