Electronic Cigarettes, Oxidative Stress, Tobacco Use
Conditions
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.
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
OTHERHigh 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)
OTHERLow 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)
OTHERHigh concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (90%)
OTHERLow concentration of Propylene Glycol
Study provided electronic cigarette liquid will have a higher percentage of propylene glycol (10%)
Sponsors
Milton S. Hershey Medical Center
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 8-isoprostane in Exhaled Breath Condensate | Baseline prior to study product use in Phase 1 | 8-isoprostane levels will be analyzed via LC-MS |
| 8-OHdG DNA Adducts in Buccal Cells | Baseline prior to study product use in Phase 1 | 8-OHdG-DNA adducts will be measured via LC-MS/MS |
| Total nicotine in Blood Samples | Baseline prior to study product use in Phase 1 | Nicotine levels will analyzed via LC-MS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| E-cigarette Puffing Behavior - Duration of Puffs | 5 minutes of directed study product laboratory use in Phase 1 | E-cigarette puff duration will be monitored via video during the 5 minutes of laboratory product usage. |
| E-cigarette Puffing Behavior - Number of Puffs | 5 minutes of directed study product laboratory use in Phase 1. | Number of e-cigarette puffs will be monitored via video during the 5 minutes of laboratory product usage. |
| E-cigarette Puffing Behavior - Interpuff Interval | 5 minutes of directed study product laboratory use in Phase 1 | E-cigarette interpuff interval will be monitored via video during the 5 minutes of laboratory product usage. |
Countries
United States
Contacts
CONTACTZachary Btizer, Ph. D.
CONTACTKenneth Houser, MS
PRINCIPAL_INVESTIGATORZachary Bitzer, Ph.D.
Penn State Hershey College of Medicine
Outcome results
None listed