Young Adult EC Use and Respiratory Outcomes

The Ohio State University

Status: Completed

Conditions: E Cig Use

Treatments: Behavioral: Other

Study type: Observational

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04395274

NCI-2024-06207 (Other Identifier)

OSU-23006

1K01HL148907-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

E-cigarette (EC) use continues to increase among youth, and EC may be detrimental to youth respiratory health. Public health officials and the Food and Drug Administration (FDA) can now regulate ECs. The proposed study uses naturalistic assessments called ecological momentary assessment (EMA) to understand how ECs use may impact the respiratory health of youth and young adult users compared to never-using peers.

Full description

Using a prospective longitudinal design, 150 youth and young adults aged 18-25 years (100 exclusive-EC users; 50 never-users) will complete 5 sessions (baseline, 3-,6-, 9-, and 12-months). Sessions will include naturalistic measures such as measures of respiratory health, questionnaires, and nasal epithelial lining fluid (NELF) nasal samples. To assess acute changes in pulmonary functioning related to tobacco product use, participants will complete twice daily EMA and home-based spirometry for the 2 weeks following the Day 1 session and the 2 weeks prior to each follow-up zoom session. Never-users will participate in a brief 15-30-minute individual interview consisting of questions related to reasons for never-EC use and other protective factors that will be used to build future prevention messaging.

Enrollment: 115 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. own a smartphone and willing to add study EMA and spirometry application to it.
2. a current exclusive-EC user (endorse ≥weekly use over the past 3 months) and report never trying OTPs
3. between the ages of 18-25 years old at the time of enrollment
4. read and speak English
5. willing to complete five, 2-week periods of daily EMA and home-based spirometry
6. never-users must indicate never trying any tobacco product to be eligible for enrollment

Exclusion criteria

1. self-reported diagnosis of lung disease including cystic fibrosis or chronic obstructive pulmonary disease; we will not exclude youth who have asthma, but will incorporate this as a covariate during analyses
2. unstable or significant psychiatric conditions (past and stable conditions will be allowed)
3. history of cardiac event or distress within the past 3 months
4. are currently pregnant, planning to become pregnant, or breastfeeding
5. are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability

Trial design

115 participants in 2 patient groups

Current E-Cigarette Users

Description:

Monitoring current e-cigarette users

Never E-Cigarette / Tobacco Users

Description:

Monitoring never users of any tobacco or e-cigarette products.