Respiratory Effects of E-Cigarettes in Obese Youth

NCT ID: NCT05869318

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2027-12-31

Brief Summary

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

Detailed Description

The investigators hypothesize that obese youth e-cigarette users will have increased e-cigarette use that will worsen respiratory function. The approach will involve a clinical trial where vaping behaviors (using puff topography) and respiratory function (spirometry, plethysmography, and diffusion capacity) will be assessed while participants vape with their own e-cigarette and, on a separate visit, with the VUSE e-cigarette.

Conditions

E-Cig Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaping

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

Group Type: EXPERIMENTAL

ECIG own

Intervention Type: OTHER

Participants will vape using their own ecig device

ECIG Vuse

Intervention Type: OTHER

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

Interventions

ECIG own

Participants will vape using their own ecig device

Intervention Type: OTHER

ECIG Vuse

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• a current e-cigarette user (≥1 vaping bout daily) for at least the past 3 months,
• 21-25 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Dharini Bhammar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dharini M Bhammar, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2023-04458

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-22219

Identifier Type: -

Identifier Source: org_study_id