Health TrialsbyHealthPanel

Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

ConditionsOxidative StressTobacco UseElectronic Cigarettes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMilton S. Hershey Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • High temperature wattage setting on electronic cigarette

    Other intervention

    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 cigarette

    Other intervention

    Study provided electronic cigarette will be set to a low wattage resulting in a lower usage temperature (200 C)

  • High concentration of Propylene Glycol

    Other intervention

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

  • Low concentration of Propylene Glycol

    Other intervention

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

Treatment groups

50 Participants
are divided into 4 treatment groups
Group A: High Wattage/High Propylene GlycolExperimental treatment 2 interventions
Group B: Low Wattage/Low Propylene GlycolExperimental treatment 2 interventions
Group C: High Wattage/Low Propylene GlycolExperimental treatment 2 interventions
Group D: Low Wattage/High Propylene GlycolExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

8-isoprostane in Exhaled Breath Condensate

8-isoprostane levels will be analyzed via LC-MS

Time frame
Baseline prior to study product use in Phase 1
2

8-isoprostane in Exhaled Breath Condensate

8-isoprostane levels will be analyzed via LC-MS

Time frame
5 minutes after directed study product use in Phase 1
3

8-isoprostane in Exhaled Breath Condensate

8-isoprostane levels will be analyzed via LC-MS

Time frame
Immediately prior to study product use in Phase 2; visit occurs after 2 weeks of at home product use
4

8-isoprostane in Exhaled Breath Condensate

8-isoprostane levels will be analyzed via LC-MS

Time frame
5 minutes after directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use

Secondary outcomes

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.

Time frame
5 minutes of directed study product laboratory use in Phase 1
2

E-cigarette Puffing Behavior - Duration of Puffs

E-cigarette puff duration will be monitored via video during the 5 minutes of laboratory product usage.

Time frame
5 minutes of directed study product laboratory use in Phase 2b; visit occurs after 2 weeks of at home product use
3

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.

Time frame
5 minutes of directed study product laboratory use in Phase 1.
4

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.

Time frame
5 minutes of directed study product use in Phase 2b; visit occurs after 2 weeks of at home product use

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: