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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05199480
Collaborator
(none)
57
1
3
15.6
3.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Tobacco flavored liquid type 1
  • Other: Tobacco flavored liquid type 2
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health
Actual Study Start Date :
Jan 10, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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

  2. Change in Maximal microvascular dilation [Change from baseline to 2 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05199480
Other Study ID Numbers:
  • HM20022776
First Posted:
Jan 20, 2022
Last Update Posted:
Feb 7, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 7, 2022