Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use; Oxidative Stress; Electronic Cigarettes
• Intervention / Treatment: Other: High temperature wattage setting on electronic cigarette; Other: High concentration of Propylene Glycol; Other: Low temperature wattage setting on electronic cigarette; Other: Low concentration of Propylene Glycol

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth Houser, MS; Phone Number: 717-531-5473; Email: khouser@pennstatehealth.psu.edu
• Study Contact Backup: Name: Zachary Btizer, Ph. D.; Phone Number: 717-531-4387; Email: zbitzer@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine
      • Contact: Kenneth Houser, MS; Phone Number: 717-531-5473; Email: khouser@pennstatehealth.psu.edu
      • Principal Investigator: Zachary Bitzer, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Wattage/High Propylene Glycol; High temperature and high propylene glycol concentration	Other: High temperature wattage setting on electronic cigarette; Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C); Other: High concentration of Propylene Glycol; Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
Experimental: Low Wattage/Low Propylene Glycol; Low temperature and low propylene glycol concentration	Other: Low temperature wattage setting on electronic cigarette; Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C); Other: Low concentration of Propylene Glycol; Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Experimental: High Wattage/Low Propylene Glycol; High temperature and low propylene glycol concentration	Other: High temperature wattage setting on electronic cigarette; Study provided electronic cigarette will be set to a high wattage resulting in a higher usage temperature (275 C); Other: Low concentration of Propylene Glycol; Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Experimental: Low Wattage/High Propylene Glycol; Low temperature and high propylene glycol concentration	Other: High concentration of Propylene Glycol; Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%); Other: Low temperature wattage setting on electronic cigarette; Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
8-isoprostane in Exhaled Breath Condensate	8-isoprostane levels will be analyzed via LC-MS	Baseline prior to study product use in Phase 1
8-isoprostane in Exhaled Breath Condensate	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	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	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	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	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	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	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	Nicotine levels will analyzed via LC-MS	Baseline prior to study product use in Phase 1
Total nicotine in Blood Samples	Nicotine level will be analyzed via LC-MS	5 minute after directed study product use in Phase 1
Total nicotine in Blood Samples	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
E-cigarette Puffing Behavior - Duration of Puffs	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Zachary Bitzer, Ph.D., Penn State Hershey College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Vaping; Tobacco Use
• Other Study ID Numbers: STUDY00028240; U54DA058271 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No