Young Adult EC Use and Respiratory Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Young Adult EC Use and Respiratory Outcomes

Conditions
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E Cig Use

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: own a smartphone and willing to add study EMA and spirometry application to it. a current exclusive-EC user (endorse ≥weekly use over the past 3 months) and report never trying OTPs between the ages of 18-25 years old at the time of enrollment read and speak English willing to complete five, 2-week periods of daily EMA and home-based spirometry never-users must indicate never trying any tobacco product to be eligible for enrollment Exclusion Criteria: 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 unstable or significant psychiatric conditions (past and stable conditions will be allowed) history of cardiac event or distress within the past 3 months are currently pregnant, planning to become pregnant, or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Current E-Cigarette Users<br>Monitoring current e-cigarette users | |
| Never E-Cigarette / Tobacco Users<br>Monitoring never users of any tobacco or e-cigarette products. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry to measure the change from baseline in forced vital capacity (FVC) | Spirometry (a pulmonary function diagnostic test) will be completed during each session. For e-cigarette users, assessments will be completed in session. | Baseline, 3-month, 6-month, 9-month, 12-month | 
| Spirometry to measure the change from baseline in forced expiratory volume (FEV) | Spirometry (a pulmonary function diagnostic test) will be completed during each session. For e-cigarette users, assessments will be completed in session. | Baseline, 3-month, 6-month, 9-month, 12-month | 
| Level of dependence by product type will be examined. | Changes in product use evaluated with an evaluation of the changes in dependence using the Hooked on Nicotine Checklist (HONC). | Baseline, 3-month, 6-month, 9-month, 12-month | 
| Respiratory health measures by nasal swab. | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarette, respiratory health, prospective