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NCT Number: NCT07612696

Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location contact

Kenneth Houser, MS

CONTACT

[email protected]

717-531-5473

Zachary Bitzer, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High temperature wattage setting on electronic cigarette

Other

Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C)

Low temperature wattage setting on electronic cigarette

Other

Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)

High concentration of Propylene Glycol

Other

Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)

Low concentration of Propylene Glycol

Other

Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)

Primary outcomes

  1. 8-isoprostane in Exhaled Breath Condensate

    Time frame: Baseline prior to study product use in Phase 1

    8-isoprostane levels will be analyzed via LC-MS

  2. 8-isoprostane in Exhaled Breath Condensate

    Time frame: 5 minutes after directed study product use in Phase 1

    8-isoprostane levels will be analyzed via LC-MS

  3. 8-isoprostane in Exhaled Breath Condensate

    Time frame: 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

  4. 8-isoprostane in Exhaled Breath Condensate

    Time frame: 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. 8-OHdG DNA Adducts in Buccal Cells

    Time frame: Baseline prior to study product use in Phase 1

    8-OHdG-DNA adducts will be measured via LC-MS/MS

  6. 8-OHdG DNA Adducts in Buccal Cells

    Time frame: 5 minutes after directed study product use in Phase 1

    8-OHdG-DNA adducts will be measured via LC-MS/MS

  7. 8-OHdG DNA Adducts in Buccal Cells

    Time frame: 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

  8. 8-OHdG DNA Adducts in Buccal Cells

    Time frame: 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

  9. Total nicotine in Blood Samples

    Time frame: Baseline prior to study product use in Phase 1

    Nicotine levels will analyzed via LC-MS

  10. Total nicotine in Blood Samples

    Time frame: 5 minute after directed study product use in Phase 1

    Nicotine level will be analyzed via LC-MS

  11. Total nicotine in Blood Samples

    Time frame: 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

  12. Total nicotine in Blood Samples

    Time frame: 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

Secondary outcomes

  1. E-cigarette Puffing Behavior - Duration of Puffs

    Time frame: 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.

  2. E-cigarette Puffing Behavior - Duration of Puffs

    Time frame: 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.

  3. E-cigarette Puffing Behavior - Number of Puffs

    Time frame: 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.

  4. E-cigarette Puffing Behavior - Number of Puffs

    Time frame: 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. E-cigarette Puffing Behavior - Interpuff Interval

    Time frame: 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.

  6. E-cigarette Puffing Behavior - Interpuff Interval

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kenneth Houser, MS

CONTACT

[email protected]

717-531-5473

Zachary Btizer, Ph. D.

CONTACT

[email protected]

717-531-4387

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 29, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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