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Not yet recruiting NCT07612696

Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

No phase Interventional Oxidative Stress Tobacco Use Electronic Cigarettes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High temperature wattage setting on electronic cigarette, Low temperature wattage setting on electronic cigarette, High concentration of Propylene Glycol, Low concentration of Propylene Glycol.
Who it may be relevant to
Registry conditions: Oxidative Stress, Tobacco Use, Electronic Cigarettes. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 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 High concentration of Propylene Glycol
    Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
  • Other Low concentration of Propylene Glycol
    Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)

Primary outcome measures

  • 8-isoprostane in Exhaled Breath Condensate [Time frame: Baseline prior to study product use in Phase 1]
  • 8-isoprostane in Exhaled Breath Condensate [Time frame: 5 minutes after directed study product use in Phase 1]
  • 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 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-OHdG DNA Adducts in Buccal Cells [Time frame: Baseline prior to study product use in Phase 1]
  • 8-OHdG DNA Adducts in Buccal Cells [Time frame: 5 minutes after directed study product use in Phase 1]
  • 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 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]
  • Total nicotine in Blood Samples [Time frame: Baseline prior to study product use in Phase 1]
  • Total nicotine in Blood Samples [Time frame: 5 minute after directed study product use in Phase 1]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Penn State College of Medicine — Hershey

Identifiers

NCT: NCT07612696 · STUDY00028240 · U54DA058271

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗