Young Adult EC Use and Respiratory Outcomes

NCT04395274 | Completed Results DMC

• 3 other identifiers: OSU-230061K01HL148907-01NCI-2024-06207
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

E Cig Use

Keywords

e-cigarette; respiratory health; prospective

Outcome Measures

Primary Outcomes (15)

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

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

  Baseline, 3-month, 6-month, 9-month, 12-month

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

  Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up 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). Scores range from 0 to 10 with higher values indicating greater levels of dependence.

  Baseline, 3-month, 6-month, 9-month, 12-month

• Respiratory Health Measures by Nasal Swab - IL-6

  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).

  Baseline, 3-month, 6-month, 9-month, 12-month

• Respiratory Health Measures by Nasal Swab - IL-8

  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

• Respiratory Health Measures by Nasal Swab - TNF-alpha

  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

• Respiratory Health Measures by Nasal Swab - IL-4

  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

• Respiratory Health Measures by Nasal Swab - IL-5

  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

• Respiratory Health Measures by Nasal Swab - IL-10

  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

• Respiratory Health Measures by Nasal Swab - IL-13

  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

• Respiratory Health Measures by Nasal Swab - TARC

  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

• Respiratory Health Measures by Nasal Swab - Eotaxin

  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

• Respiratory Health Measures by Nasal Swab - MCP-1

  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

• Respiratory Health Measures by Nasal Swab - MCP-4

  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

• Respiratory Health Measures by Nasal Swab - Cotinine

  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

Study Arms (2)

Current E-Cigarette Users

Monitoring current e-cigarette users

Never E-Cigarette / Tobacco Users

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

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43214, United States

Location

Related Links

• The Jamesline

Biospecimen

Retention: SAMPLES WITHOUT DNA

salivary collection, respiratory health

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Results Point of Contact

• Title: Dr. Alayna Tackett
• Organization: Ohio State University Comprehensive Cancer Center

alayna.tackett@osumc.edu

614-558-2679

Study Officials

• Alayna Tackett, PhD

  The Ohio State Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 20, 2020
• Study Start: December 15, 2021
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)