Impact of Electronic Cigarette Temperature and Solvent on Biomarkers
24. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Kenneth Houser, MS
- Telefonnummer: 717-531-5473
- E-mail: khouser@pennstatehealth.psu.edu
Undersøgelse Kontakt Backup
- Navn: Zachary Btizer, Ph. D.
- Telefonnummer: 717-531-4387
- E-mail: zbitzer@pennstatehealth.psu.edu
Studiesteder
-
-
Pennsylvania
-
Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State College of Medicine
-
Kontakt:
- Kenneth Houser, MS
- Telefonnummer: 717-531-5473
- E-mail: khouser@pennstatehealth.psu.edu
-
Ledende efterforsker:
- Zachary Bitzer, Ph.D.
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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%)
|
|
Eksperimentel: 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%)
|
|
Eksperimentel: 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%)
|
|
Eksperimentel: 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)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Zachary Bitzer, Ph.D., Penn State Hershey College of Medicine
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. august 2028
Studieafslutning (Anslået)
1. december 2028
Datoer for studieregistrering
Først indsendt
13. maj 2026
Først indsendt, der opfyldte QC-kriterier
24. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00028240
- U54DA058271 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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