Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

NCT07612696 | Not Yet Recruiting

• 2 other identifiers: STUDY00028240U54DA058271
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxidative Stress; Tobacco Use; Electronic Cigarettes

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• E-cigarette Puffing Behavior - Duration of Puffs

  5 minutes of directed study product laboratory use in Phase 1

• E-cigarette Puffing Behavior - Duration of Puffs

  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

  5 minutes of directed study product laboratory use in Phase 1.

• E-cigarette Puffing Behavior - Number of Puffs

  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

  5 minutes of directed study product laboratory use in Phase 1

Study Arms (4)

High Wattage/High Propylene Glycol

EXPERIMENTAL

High temperature and high propylene glycol concentration

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

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

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

Other: Low temperature wattage setting on electronic cigarette; Other: High concentration of Propylene Glycol

Interventions

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)

High Wattage/High Propylene Glycol; High Wattage/Low Propylene Glycol

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)

Low Wattage/High Propylene Glycol; Low Wattage/Low Propylene Glycol

High concentration of Propylene Glycol OTHER

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

High Wattage/High Propylene Glycol; Low Wattage/High Propylene Glycol

Low concentration of Propylene Glycol OTHER

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

High Wattage/Low Propylene Glycol; Low Wattage/Low Propylene Glycol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Tobacco Use; Vaping

Condition Hierarchy (Ancestors)

Behavior; Smoking

Study Officials

• Zachary Bitzer, Ph.D.

  Penn State Hershey College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Btizer, Ph. D.

CONTACT

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

Kenneth Houser, MS

CONTACT

717-531-5473; khouser@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Public Health Sciences

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)