NCT05869318

Brief Summary

To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress65%
Apr 2023Dec 2027

Study Start

First participant enrolled

April 4, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

May 11, 2023

Last Update Submit

October 15, 2025

Conditions

E-Cig Use

Outcome Measures

Primary Outcomes (7)

  • Forced expiratory volume in 1 second

    Spirometry will be completed before and after a 35 min vaping session

    Change from 0 to 35 minutes

  • Functional residual capacity

    Plethymosgraphy will be completed before and after a 35 min vaping session

    Change from 0 to 35 minutes

  • Diffusion capacity

    DLCO will be completed before and after a 35 min vaping session

    Change from 0 to 35 minutes

  • Airway resistance

    Plethymosgraphy to measure airway resistance (Raw) will be completed before and after a 35 min vaping session

    Change from 0 to 35 minutes

  • Puff count

    E-cig puff topography data collection for abuse liability

    35 minutes

  • Average Puff duration

    E-cig puff topography data collection for abuse liability

    35 minutes

  • Average Puff volume

    E-cig puff topography data collection for abuse liability

    35 minutes

Secondary Outcomes (3)

  • Tiffany-Drobes Questionnaire of Smoking Urges

    Change from 0 to 35 minutes

  • Respiratory health questionnaire

    Change from 0 to 35 minutes

  • Exhaled carbon monoxide

    Change from 0 to 35 minutes

Study Arms (1)

Vaping

EXPERIMENTAL

All participants will undergo two vaping sessions: one using their own device and one using the study device

Other: ECIG ownOther: ECIG Vuse

Interventions

ECIG ownOTHER

Participants will vape using their own ecig device

Vaping
ECIG VuseOTHER

Participants will vape a VUSE e-cigarette (GOLD 5%)

Vaping

Eligibility Criteria

Age21 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • a current e-cigarette user (≥1 vaping bout daily) for at least the past 3 months,
  • years old,
  • willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions,
  • willing to complete five lab visits lasting up to 4 hours each,
  • able to read and speak English,
  • willing to provide informed consent.

You may not qualify if:

  • self-reported diagnosis of lung disease including asthma or cystic fibrosis
  • history of cardiac event or distress within the past 3 months
  • history of metabolic disease including thyroid disease or diabetes
  • history of orthopedic or neuromuscular problems that preclude exercise
  • currently pregnant (determined using urine pregnancy test), planning to become pregnant, delivered a child in the past 6 weeks even if not breastfeeding, or currently breastfeeding
  • use of other tobacco products \>10 days in the past month
  • current marijuana use \>10 times per month
  • currently engaging in a vaping cessation attempt
  • ) competitive athlete or individual currently engaged in an exercise training program involving 420min or more (moderate intensity aerobic activity) or 210 min or more (vigorous intensity aerobic activity) per week with the goal of participating in a competitive event or marathon, triathlon, etc. Participants who are engaged in usual physical activity (e.g., walking dog, biking to work, etc.) but not engaged in a "structured exercise training program" will not be excluded.
  • plans to leave the Columbus or central Ohio region within the next year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Officials

  • Dharini M Bhammar, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 22, 2023

Study Start

April 4, 2023

Primary Completion

May 21, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)