Oxidative StressNCT07612696
Impact of Electronic Cigarette Temperature and Solvent on Biomarkers
A study testing High temperature wattage setting on electronic cigarette, Low temperature wattage setting on electronic cigarette and High concentration of Propylene Glycol in people with Oxidative Stress and Tobacco Use, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Oxidative Stress, Tobacco Use, Electronic Cigarettes
- What is being tested?
- High temperature wattage setting on electronic cigarette, Low temperature wattage setting on electronic cigarette and High concentration of Propylene Glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Kenneth Houser, MS, 717-531-5473, khouser@pennstatehealth.psu.edu
Zachary Bitzer, Ph.D.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Oxidative Stress, Tobacco Use, Electronic Cigarettes
- Being tested
- High temperature wattage setting on electronic cigarette, Low temperature wattage setting on electronic cigarette, High concentration of Propylene Glycol, Low concentration of Propylene Glycol
- Medical subject headings
- Tobacco Use, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High temperature wattage setting on electronic cigaretteOther
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 cigaretteOther
Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)
High concentration of Propylene GlycolOther
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Low concentration of Propylene GlycolOther
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
| Study group | Role | What they receive |
|---|---|---|
| High Wattage/High Propylene Glycol | Experimental | High temperature and high propylene glycol concentration Receives: Other: High temperature wattage setting on electronic cigarette; Other: High concentration of Propylene Glycol |
| Low Wattage/Low Propylene Glycol | Experimental | Low temperature and low propylene glycol concentration Receives: Other: Low temperature wattage setting on electronic cigarette; Other: Low concentration of Propylene Glycol |
| High Wattage/Low Propylene Glycol | Experimental | High temperature and low propylene glycol concentration Receives: Other: High temperature wattage setting on electronic cigarette; Other: Low concentration of Propylene Glycol |
| Low Wattage/High Propylene Glycol | Experimental | Low temperature and high propylene glycol concentration Receives: Other: Low temperature wattage setting on electronic cigarette; Other: High concentration of Propylene Glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-isoprostane in Exhaled Breath Condensate
8-isoprostane levels will be analyzed via LC-MS
Measured: Baseline prior to study product use in Phase 1
8-isoprostane in Exhaled Breath Condensate
8-isoprostane levels will be analyzed via LC-MS
Measured: 5 minutes after directed study product use in Phase 1
8-isoprostane in Exhaled Breath Condensate
8-isoprostane levels will be analyzed via LC-MS
Measured: 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
8-isoprostane levels will be analyzed via LC-MS
Measured: 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
8-OHdG-DNA adducts will be measured via LC-MS/MS
Measured: Baseline prior to study product use in Phase 1
8-OHdG DNA Adducts in Buccal Cells
8-OHdG-DNA adducts will be measured via LC-MS/MS
Measured: 5 minutes after directed study product use in Phase 1
8-OHdG DNA Adducts in Buccal Cells
8-OHdG-DNA adducts will be measured via LC-MS/MS
Measured: 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
8-OHdG-DNA adducts will be measured via LC-MS/MS
Measured: 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
Nicotine levels will analyzed via LC-MS
Measured: Baseline prior to study product use in Phase 1
Total nicotine in Blood Samples
Nicotine level will be analyzed via LC-MS
Measured: 5 minute after directed study product use in Phase 1
Total nicotine in Blood Samples
Nicotine levels will be analyzed via LC-MS
Measured: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
Total nicotine in Blood Samples
Nicotine levels will be analyzed via LC-MS
Measured: 5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
Secondary outcomes (6)
E-cigarette Puffing Behavior - Duration of Puffs
E-cigarette puff duration will be monitored via video during the 5 minutes of laboratory product usage.
Measured: 5 minutes of directed study product laboratory use in Phase 1
E-cigarette Puffing Behavior - Duration of Puffs
E-cigarette puff duration will be monitored via video during the 5 minutes of laboratory product usage.
Measured: 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
Number of e-cigarette puffs will be monitored via video during the 5 minutes of laboratory product usage.
Measured: 5 minutes of directed study product laboratory use in Phase 1.
E-cigarette Puffing Behavior - Number of Puffs
Number of e-cigarette puffs will be monitored via video during the 5 minutes of laboratory product usage.
Measured: 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
E-cigarette interpuff interval will be monitored via video during the 5 minutes of laboratory product usage.
Measured: 5 minutes of directed study product laboratory use in Phase 1
E-cigarette Puffing Behavior - Interpuff Interval
E-cigarette interpuff interval will be monitored via video during the 5 minutes of laboratory product usage.
Measured: 5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 Oct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Zachary Bitzer, Milton S. Hershey Medical Center
- Investigators
- Zachary Bitzer, Ph.D., Principal investigator, Penn State Hershey College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612696
- Sponsor's protocol ID
- STUDY00028240
- Other IDs
- U54DA058271
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure
- ClinicalTrials.gov ID
- NCT07612696
- Acronym / sponsor ID
- STUDY00028240
- Conditions
- Oxidative Stress, Tobacco Use, Electronic Cigarettes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Wattage/High Propylene Glycol | Experimental | Other: High temperature wattage setting on electronic cigarette, Other: High concentration of Propylene GlycolHigh temperature and high propylene glycol concentration |
| Low Wattage/Low Propylene Glycol | Experimental | Other: Low temperature wattage setting on electronic cigarette, Other: Low concentration of Propylene GlycolLow temperature and low propylene glycol concentration |
| High Wattage/Low Propylene Glycol | Experimental | Other: High temperature wattage setting on electronic cigarette, Other: Low concentration of Propylene GlycolHigh temperature and low propylene glycol concentration |
| Low Wattage/High Propylene Glycol | Experimental | Other: Low temperature wattage setting on electronic cigarette, Other: High concentration of Propylene GlycolLow temperature and high propylene glycol concentration |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High temperature wattage setting on electronic cigaretteStudy provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C) | Other | High Wattage/High Propylene Glycol, High Wattage/Low Propylene Glycol |
| Low temperature wattage setting on electronic cigaretteStudy provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C) | Other | Low Wattage/High Propylene Glycol, Low Wattage/Low Propylene Glycol |
| High concentration of Propylene GlycolStudy provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%) | Other | High Wattage/High Propylene Glycol, Low Wattage/High Propylene Glycol |
| Low concentration of Propylene GlycolStudy provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%) | Other | High Wattage/Low Propylene Glycol, Low Wattage/Low Propylene Glycol |
Primary outcome
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
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
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
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
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
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
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-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
Total nicotine in Blood Samples
Time frame: Baseline prior to study product use in Phase 1
Nicotine levels will analyzed via LC-MS
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
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
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
6 secondary outcomes
E-cigarette Puffing Behavior - Duration of Puffs
Time frame: 5 minutes of directed study product laboratory use in Phase 1
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 Puffing Behavior - Number of Puffs
Time frame: 5 minutes of directed study product laboratory use in Phase 1.
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
E-cigarette Puffing Behavior - Interpuff Interval
Time frame: 5 minutes of directed study product laboratory use in Phase 1
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Oxidative Stress
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingObservational study
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Gaucher Disease Type I, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zachary Bitzer, Ph.D. principal investigator
Penn State Hershey College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High temperature wattage setting on electronic cigarette, Low temperature wattage setting on electronic cigarette and High concentration of Propylene Glycol in people with Oxidative Stress and Tobacco Use, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zachary Btizer, Ph. D. (717-531-4387, zbitzer@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
8-isoprostane in Exhaled Breath Condensate (time frame: Baseline prior to study product use in Phase 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.