Clinical trial NCT04395274: Young Adult EC Use and Respiratory Outcomes
Official title: Young Adult EC Use and Respiratory Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: E Cig Use
Keywords: e-cigarette
respiratory health
prospective
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Food and Drug Administration (FDA)
First posted: 2020-05-20
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present proposal, a study of e-cigarette use among youth and young adults, will include both females and racial/ethnic minorities.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Level of Dependence by Product Type Will be Examined.
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - IL-6
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - IL-8
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - TNF-alpha
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - IL-4
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - IL-5
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - IL-10
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - IL-13
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - TARC
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - Eotaxin
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - MCP-1
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - MCP-4
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
measure: Respiratory Health Measures by Nasal Swab - Cotinine
timeFrame: Baseline, 3-month, 6-month, 9-month, 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: The Ohio State Comprehensive Cancer Center
name: Alayna Tackett, PhD
role: PRINCIPAL_INVESTIGATOR
References: