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Completed

NCT Number: NCT04395274

Young Adult EC Use and Respiratory Outcomes

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.

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Key information

Conditions

E Cig Use Behavior Smoking Vaping

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability

Treatment and study plan

Primary outcomes

  1. Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.

  2. Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.

  3. Level of Dependence by Product Type Will be Examined.

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    Changes in product use evaluated with an evaluation of the changes in dependence using the Hooked on Nicotine Checklist (HONC).

    Scores range from 0 to 10 with higher values indicating greater levels of dependence.

  4. Respiratory Health Measures by Nasal Swab - IL-6

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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).

  5. Respiratory Health Measures by Nasal Swab - IL-8

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  6. Respiratory Health Measures by Nasal Swab - TNF-alpha

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  7. Respiratory Health Measures by Nasal Swab - IL-4

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  8. Respiratory Health Measures by Nasal Swab - IL-5

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  9. Respiratory Health Measures by Nasal Swab - IL-10

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  10. Respiratory Health Measures by Nasal Swab - IL-13

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  11. Respiratory Health Measures by Nasal Swab - TARC

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  12. Respiratory Health Measures by Nasal Swab - Eotaxin

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  13. Respiratory Health Measures by Nasal Swab - MCP-1

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  14. Respiratory Health Measures by Nasal Swab - MCP-4

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

  15. Respiratory Health Measures by Nasal Swab - Cotinine

    Time frame: Baseline, 3-month, 6-month, 9-month, 12-month

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 20, 2020
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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