NCT07215065

Brief Summary

This study investigates heavy metal exposure in young adults who use electronic cigarettes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2025May 2026

First Submitted

Initial submission to the registry

October 8, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

October 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

February 17, 2026

Status Verified

October 1, 2025

Enrollment Period

7 months

First QC Date

October 8, 2025

Last Update Submit

February 13, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Heavy metal concentration in the saliva of e-cigarette users

    Identify and quantify HM concentrations in the saliva among all participants in the sample before and after their 30 minute vaping session.

    Baseline, Immediately Following Vaping Session

  • Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)

    Participants will complete spirometry (a pulmonary function test) before and immediately after the completion of the 30 minute vaping session.

    Baseline, Immediately Following Vaping Session

  • Spirometry to Measure the Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

    Participants will complete spirometry (a pulmonary function test) before and immediately after the completion of the 30 minute vaping session.

    Baseline, Immediately Following Vaping Session

  • E-cigarette puffing behavior

    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.

    Up to 30 minutes

Study Arms (1)

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study

Also known as: Non-Interventional Observational Study
Observational

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adults (aged 18 - 29 years) who are established and current EC users.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

Study Officials

  • Alayna P Tackett, PhD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2025

First Posted

October 10, 2025

Study Start

October 22, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

February 17, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations