Respiratory Effects of E-Cigarettes in Obese Youth

Study Overview
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Brief Summary
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To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.

Detailed Description
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The investigators hypothesize that obese youth e-cigarette users will have increased e-cigarette use that will worsen respiratory function. The approach will involve a clinical trial where vaping behaviors (using puff topography) and respiratory function (spirometry, plethysmography, and diffusion capacity) will be assessed while participants vape with their own e-cigarette and, on a separate visit, with the VUSE e-cigarette.

Official Title
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RESEC: Respiratory Effects of E-Cigarettes in Obese Youth

Conditions
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E-Cig Use

Intervention / Treatment
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* Other: ECIG own
* Other: ECIG Vuse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a current e-cigarette user (≥1 vaping bout daily) for at least the past 3 months, 21-25 years old, willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions, willing to complete five lab visits lasting up to 4 hours each, able to read and speak English, willing to provide informed consent. Exclusion Criteria: self-reported diagnosis of lung disease including asthma or cystic fibrosis history of cardiac event or distress within the past 3 months history of metabolic disease including thyroid disease or diabetes history of orthopedic or neuromuscular problems that preclude exercise currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding use of other tobacco products >10 days in the past month current marijuana use >10 times per month currently engaging in a vaping cessation attempt ) competitive athlete or individual currently engaged in an exercise training program involving 420min or more (moderate intensity aerobic activity) or 210 min or more (vigorous intensity aerobic activity) per week with the goal of participating in a competitive event or marathon, triathlon, etc. Participants who are engaged in usual physical activity (e.g., walking dog, biking to work, etc.) but not engaged in a structured exercise training program will not be excluded. plans to leave the Columbus or central Ohio region within the next year.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaping<br>All participants will undergo two vaping sessions: one using their own device and one using the study device | Other: ECIG own<br>* Participants will vape using their own ecig device<br>Other: ECIG Vuse<br>* Participants will vape a VUSE e-cigarette (GOLD 5%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second | Spirometry will be completed before and after a 35 min vaping session | Change from 0 to 35 minutes | 
| Functional residual capacity | Plethymosgraphy will be completed before and after a 35 min vaping session | Change from 0 to 35 minutes | 
| Diffusion capacity | DLCO will be completed before and after a 35 min vaping session | Change from 0 to 35 minutes | 
| Airway resistance | Plethymosgraphy to measure airway resistance (Raw) will be completed before and after a 35 min vaping session | Change from 0 to 35 minutes | 
| Puff count | E-cig puff topography data collection for abuse liability | 35 minutes | 
| Average Puff duration | E-cig puff topography data collection for abuse liability | 35 minutes | 
| Average Puff volume | E-cig puff topography data collection for abuse liability | 35 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tiffany-Drobes Questionnaire of Smoking Urges | Assess E-cig craving/suppression of craving | Change from 0 to 35 minutes | 
| Respiratory health questionnaire | Assess respiratory symptoms | Change from 0 to 35 minutes | 
| Exhaled carbon monoxide | Assess carbon monoxide in exhaled air | Change from 0 to 35 minutes |