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

Early Phase 1

Completed

• Conditions: E-Cig Use
• Interventions: Drug: Tobacco flavored liquid type 1; Drug: Tobacco flavored liquid type 2

• Registration Number: NCT05199480
• Lead Sponsor: Virginia Commonwealth University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-05
• Study Start: 2022-01-10
• Study First Posted: 2022-01-20
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E-cigarette liquid type 1	Tobacco flavored 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.
E-cigarettes liquid type 2	Tobacco flavored 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Maximal microvascular dilation	Change from baseline to 2 weeks	Participants' microvascular function (maximal dilation) will be measured using local thermal hyperemia.
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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States