Young Adult EC Use and Respiratory Outcomes

Conditions

E Cig Use

Keywords

e-cigarette, respiratory health, prospective

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.

Related papers

No related papers found yet.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)	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.
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)	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.
Level of Dependence by Product Type Will be Examined.	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.
Respiratory Health Measures by Nasal Swab - IL-6	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).
Respiratory Health Measures by Nasal Swab - IL-8	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.
Respiratory Health Measures by Nasal Swab - TNF-alpha	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.
Respiratory Health Measures by Nasal Swab - IL-4	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.
Respiratory Health Measures by Nasal Swab - IL-5	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.
Respiratory Health Measures by Nasal Swab - IL-10	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.
Respiratory Health Measures by Nasal Swab - IL-13	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.
Respiratory Health Measures by Nasal Swab - TARC	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.
Respiratory Health Measures by Nasal Swab - Eotaxin	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.
Respiratory Health Measures by Nasal Swab - MCP-1	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.
Respiratory Health Measures by Nasal Swab - MCP-4	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.
Respiratory Health Measures by Nasal Swab - Cotinine	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.

Countries

United States

Participant flow

Pre-assignment details

Participants are assigned to a study arm (Current E-Cigarette User or Never E-Cigarette/Tobacco User) after completion of the baseline survey. 10 Participants were found to be ineligible due to their tobacco use patterns reported at baseline, these participants were excluded from the study prior to being assigned to a study arm and are not included in the participant flow.

Participants by arm

Arm	Count
Current E-Cigarette Users Monitoring current e-cigarette users	52
Never E-Cigarette / Tobacco Users Monitoring never users of any tobacco or e-cigarette products.	53
Total	105

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	20	11
Overall Study	Moved Abroad	0	1
Overall Study	Withdrawal by Subject	13	10

Baseline characteristics

Characteristic	Current E-Cigarette Users	Never E-Cigarette / Tobacco Users	Total
Age, Continuous	21.81 years STANDARD_DEVIATION 2.11	20.11 years STANDARD_DEVIATION 2.01	20.95 years STANDARD_DEVIATION 2.22
Days used e-cigarettes in past 30 days	26.38 days STANDARD_DEVIATION 6.24	0 days STANDARD_DEVIATION 0	13.07 days STANDARD_DEVIATION 13.96
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	14 Participants	14 Participants	28 Participants
Race (NIH/OMB) Black or African American	6 Participants	7 Participants	13 Participants
Race (NIH/OMB) More than one race	6 Participants	7 Participants	13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants	3 Participants	9 Participants
Race (NIH/OMB) White	20 Participants	22 Participants	42 Participants
Sex: Female, Male Female	29 Participants	45 Participants	74 Participants
Sex: Female, Male Male	23 Participants	8 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 52	0 / 53
other Total, other adverse events	11 / 52	0 / 53
serious Total, serious adverse events	0 / 52	0 / 53

Outcome results

Primary

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.