Not Yet RecruitingNot Applicable

Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

United States50 participantsStarted 2026-07-15

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is measuring oxidative stress markers like 8-isoprostane and DNA damage indicators in my breath and cheek cells — what do those biomarkers actually tell us about the harm being done to my body from e-cigarette use, and why would that matter for my health going forward?
2Since this trial is not yet recruiting, do you know when it's expected to open, and is there any reason I should wait for it versus making changes to my tobacco or e-cigarette use right now?
3The study seems to be comparing different e-cigarette temperatures and solvents rather than testing a treatment — does participating in something like this involve any continued e-cigarette exposure that could affect my health, and is that something we should weigh carefully given my current condition?
4This trial also measures nicotine levels in the blood across different conditions — given what you know about my health, could the nicotine exposure involved in a study like this pose any particular risks for me that we should discuss before I consider it?
5Are there standard cessation programs or treatments for tobacco use that might be a better or more immediate priority for me compared to joining an observational study like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

8-isoprostane in Exhaled Breath Condensate

Timeframe: Baseline prior to study product use in Phase 1

8-isoprostane in Exhaled Breath Condensate

Timeframe: 5 minutes after directed study product use in Phase 1

8-isoprostane in Exhaled Breath Condensate

Timeframe: 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

Timeframe: 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

Timeframe: Baseline prior to study product use in Phase 1

8-OHdG DNA Adducts in Buccal Cells

Timeframe: 5 minutes after directed study product use in Phase 1

8-OHdG DNA Adducts in Buccal Cells

Timeframe: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use

Trial details

NCT IDNCT07612696

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08

Contact for this trial

Zachary Btizer, Ph. D.

717-531-4387 zbitzer@pennstatehealth.psu.edu

View on ClinicalTrials.gov More Oxidative Stress trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

8-isoprostane in Exhaled Breath Condensate

Timeframe: Baseline prior to study product use in Phase 1

8-isoprostane in Exhaled Breath Condensate

Timeframe: 5 minutes after directed study product use in Phase 1

8-isoprostane in Exhaled Breath Condensate

Timeframe: 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

Timeframe: 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

Timeframe: Baseline prior to study product use in Phase 1

8-OHdG DNA Adducts in Buccal Cells

Timeframe: 5 minutes after directed study product use in Phase 1

8-OHdG DNA Adducts in Buccal Cells

Timeframe: Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use