Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: E-cigarette liquid type 1 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
A commercially available cartridge-based device with tobacco flavored liquid.
|
Active Comparator: E-cigarettes liquid type 2 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
A commercially available cartridge-based device with tobacco flavored liquid.
|
No Intervention: No e-cigarettes No e-cigarette use |
Outcome Measures
Primary Outcome Measures
- Change in Peak oxygen consumption (VO2 peak) [Change from baseline to 2 weeks]
Participants' peak oxygen consumption (VO2 peak) will be measured using a standardized exercise capacity test performed on a stationary bike.
- Change in Expiratory Volume [Change from baseline to 2 weeks]
Participants expiratory volume will be measured through spirometry using a pulmonary function device.
Secondary Outcome Measures
- Change in Skeletal muscle O2 utilization [Change from baseline to 2 weeks]
Assessment of skeletal muscle oxygen utilization using near-infrared spectroscopy through the ratio of O2 delivery and O2 extraction
- Change in Maximal microvascular dilation [Change from baseline to 2 weeks]
Participants' microvascular function (maximal dilation) will be measured using local thermal hyperemia.
Eligibility Criteria
Criteria
Inclusion Criteria:
E-Cigarette group:
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21 years of age or older
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Used e-cigarettes (≥3 times/week for ≥3 months)
Non e-cigarette group
● 21 years of age or older
Exclusion Criteria:
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20 years old and younger
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Use of cigarettes for 15 days or more in the past 60 days
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Use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days
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Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days
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Known allergy to propylene glycol or vegetable glycerin
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Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, or cerebral diseases
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Disorder or use of medication that affects cardiopulmonary health
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Evidence of pregnancy or current nursing
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Paula Rodriguez Miguelez, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM20022776