Examining Heavy Metal Exposure and Respiratory Health in Young Adult Electronic Cigarette Users
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Heavy metal concentration in the saliva of e-cigarette users
Study Overview
Brief Summary
This study investigates heavy metal exposure in young adults who use electronic cigarettes.
Detailed Description
PRIMARY OBJECTIVES:
I. Identify and quantify heavy metals (HM) concentration in the saliva of e-cigarette users.
II. Examine changes in pulmonary functioning and HM concentration pre/post vaping.
III. Examine the association between vaping intensity and HM concentration in the saliva of e-cigarette users.
OUTLINE: This is an observational study.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 29 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18-29 years
- •Established electronic cigarette (EC) user (participant uses ECs on a daily/weekly basis [used on ≥ 5 days in past 30-days] for the past 3 months)
- •Willing to abstain from nicotine for at least 12 hours before the laboratory visit
- •Willing to not eat food or drink water/beverages for at least 30 minutes before the laboratory visit [required for salivary collection]
- •Utilize 4th generation EC products (pod-mod or disposable EC products; e.g., JUUL, Hyde)
- •Must be able to read and write in English
Exclusion Criteria
- •Recently COVID-19+ (defined as a positive test in the past 30 days) or a recent COVID-19 hospitalization (within the past 6 months)
- •Attempting to quit the use of ECs
- •Is pregnant, planning on becoming pregnant and/or breastfeeding [will be verified using a urine pregnancy test]
- •Self-reported severe or significant psychological and/or psychiatric conditions [e.g., not currently receiving treatment/medication; only past and/or stable conditions will be allowed]
- •A history of cardiac events and/or distress within the past 3 months
- •Diagnosed with a chronic, serious lung disease or current infection (e.g., pneumonia, pulmonary edema)
- •Are deaf, hard of hearing, or have a severe motor disability
Arms & Interventions
Observational
Participants vape their own electronic cigarette device as much or as little as they like over 30 minutes on study. Participants also undergo saliva sample collection, spirometry to measure respiratory function, and complete questionnaires.
Intervention: Non-Interventional Study (Other)
Outcomes
Primary Outcomes
Heavy metal concentration in the saliva of e-cigarette users
Time Frame: Baseline, Immediately Following Vaping Session
Identify and quantify HM concentrations in the saliva among all participants in the sample before and after their 30 minute vaping session.
Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
Time Frame: Baseline, Immediately Following Vaping Session
Participants will complete spirometry (a pulmonary function test) before and immediately after the completion of the 30 minute vaping session.
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Time Frame: Baseline, Immediately Following Vaping Session
Participants will complete spirometry (a pulmonary function test) before and immediately after the completion of the 30 minute vaping session.
E-cigarette puffing behavior
Time Frame: Up to 30 minutes
E-cigarette puffing behavior will be measured with a topography device that records frequency, duration, and flow rate of e-cigarette puffs. These measures are combined to inform the overall measure of e-cigarette puffing behavior.
Secondary Outcomes
No secondary outcomes reported
Investigators
Alayna Tackett
Principal Investigator
Ohio State University Comprehensive Cancer Center