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

E-Cig Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199480
• Other study ID #: HM20022776
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 10, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: Paula Rodriguez Miguelez, PhD
• Phone: 804-396-4498
• Email: prodriguezmig[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• E-Cig Use

Intervention

Drug:
• Tobacco flavored liquid type 1
A commercially available cartridge-based device with tobacco flavored liquid.
• Tobacco flavored liquid type 2
A commercially available cartridge-based device with tobacco flavored liquid.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Expiratory Volume	Participants expiratory volume will be measured through spirometry using a pulmonary function device.	Change from baseline to 2 weeks
Secondary	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
Secondary	Change in Maximal microvascular dilation	Participants' microvascular function (maximal dilation) will be measured using local thermal hyperemia.	Change from baseline to 2 weeks