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

Study Overview

• Status: Recruiting
• Conditions: E-Cig Use
• Intervention / Treatment: Other: Tobacco flavored liquid type 1; Other: Tobacco flavored liquid type 2

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paula Rodriguez Miguelez, PhD; Phone Number: 804-396-4498; Email: prodriguezmig@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Paula Rodriguez Miguelez, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HM20022776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No