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OpenTrials
Completed

NCT Number: NCT05199480

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

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

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Key information

Conditions

E-Cig Use Behavior Smoking Vaping

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tobacco flavored liquid type 1

Drug

A commercially available cartridge-based device with tobacco flavored liquid.

Tobacco flavored liquid type 2

Drug

A commercially available cartridge-based device with tobacco flavored liquid.

Primary outcomes

  1. Change in Peak oxygen consumption (VO2 peak)

    Time frame: 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.

  2. Change in Expiratory Volume

    Time frame: Change from baseline to 2 weeks

    Participants expiratory volume will be measured through spirometry using a pulmonary function device.

Secondary outcomes

  1. Change in Skeletal muscle O2 utilization

    Time frame: 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

  2. Change in Maximal microvascular dilation

    Time frame: Change from baseline to 2 weeks

    Participants' microvascular function (maximal dilation) will be measured using local thermal hyperemia.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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