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.

Study Overview

• Status: Recruiting
• Conditions: E Cig Use
• Intervention / Treatment: Behavioral: Other

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.

• Study Type: Observational
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • The Ohio State University
      • Contact: Logan Miller; Phone Number: 844-744-2447; Email: Tackett-Lab@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 21 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Current E-Cigarette Users; Monitoring current e-cigarette users
Never E-Cigarette / Tobacco Users; Monitoring never users of any tobacco or e-cigarette products.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Alayna Tackett, PhD, The Ohio State Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: prospective; e-cigarette; respiratory health
• Other Study ID Numbers: OSU-23006; 1K01HL148907-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes