Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health

Study Overview
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Brief Summary
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Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health

Official Title
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Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health

Conditions
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E-Cig Use

Intervention / Treatment
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* Other: Tobacco flavored liquid type 1
* Other: Tobacco flavored liquid type 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: E-Cigarette group: 21 years of age or older Used e-cigarettes (≥3 times/week for ≥3 months) Non e-cigarette group ● 21 years of age or older Exclusion Criteria: 20 years old and younger Use of cigarettes for 15 days or more in the past 60 days Use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days Known allergy to propylene glycol or vegetable glycerin Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, or cerebral diseases Disorder or use of medication that affects cardiopulmonary health Evidence of pregnancy or current nursing

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cigarette liquid type 1<br>Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period. | Other: Tobacco flavored liquid type 1<br>* A commercially available cartridge-based device with tobacco flavored liquid.<br>|
| Active Comparator: E-cigarettes liquid type 2<br>Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period. | Other: Tobacco flavored liquid type 2<br>* A commercially available cartridge-based device with tobacco flavored liquid.<br>|
| No Intervention: No e-cigarettes<br>No e-cigarette use | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak oxygen consumption (VO2 peak) | Participants' peak oxygen consumption (VO2 peak) will be measured using a standardized exercise capacity test performed on a stationary bike. | Change from baseline to 2 weeks | 
| Change in Expiratory Volume | Participants expiratory volume will be measured through spirometry using a pulmonary function device. | Change from baseline to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skeletal muscle O2 utilization | Assessment of skeletal muscle oxygen utilization using near-infrared spectroscopy through the ratio of O2 delivery and O2 extraction | Change from baseline to 2 weeks | 
| Change in Maximal microvascular dilation | Participants' microvascular function (maximal dilation) will be measured using local thermal hyperemia. | Change from baseline to 2 weeks |