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

NCT05199480 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HM20022776
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

E-Cig Use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Skeletal muscle O2 utilization

  Change from baseline to 2 weeks

• Change in Maximal microvascular dilation

  Change from baseline to 2 weeks

Study Arms (3)

E-cigarette liquid type 1

EXPERIMENTAL

Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period.

Drug: Tobacco flavored liquid type 1

E-cigarettes liquid type 2

ACTIVE COMPARATOR

Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period.

Drug: Tobacco flavored liquid type 2

No e-cigarettes

NO INTERVENTION

No e-cigarette use

Interventions

Tobacco flavored liquid type 1 DRUG

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

E-cigarette liquid type 1

Tobacco flavored liquid type 2 DRUG

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

E-cigarettes liquid type 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• E-Cigarette group:
• years of age or older
• Used e-cigarettes (≥3 times/week for ≥3 months)
• Non e-cigarette group
• ● 21 years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Paula Rodriguez Miguelez, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 20, 2022
• Study Start: January 10, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)