The Impact of Chronic E-Cigarette Usage on Microvascular Health

NCT06860698 | Recruiting FDA Drug

• 1 other identifier: HM20029023
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The study is focused on investigating the mechanisms involved in microvascular health in subjects that use e-cigarettes frequently. To explore microvascular health, different techniques and compounds. For one of the tests, iontophoresis, the drug's use will be stored and handled as described by the approved IND and non-IDS plan.

Conditions

E-Cig Use

Keywords

Microvascular Health

Outcome Measures

Primary Outcomes (2)

• Endothelial dependent dilation

  Endothelial-dependent dilation will be assessed using laser doppler speckle contrast in both groups through the intervention

  Participation is one week

• Neurogenic response

  Neurogenic response will be assessed using axon reflex in both groups through the intervention

  Participation is one week

Study Arms (2)

Chronic e-cigs users

Used e-cigarettes with nicotine (≥3 times/week for ≥6 months)

Other: E-cig use

Never Users

Use of cigarettes or other tobacco products less than 50 times in their lifetime.

Other: E-cig use

Interventions

E-cig use OTHER

Based on e-cigarette usage, participants will be divided into those who used e-cigarettes and those who did not use e-cigarettes

Chronic e-cigs users; Never Users

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Chronic e-cigs users and never users that are between 18 and 29 years of age.

You may qualify if:

• Between 18 and 29 years of age
• Used e-cigarettes with nicotine (≥3 times/week for ≥6 months)

You may not qualify if:

• years old and younger or 30 years old or older.
• Former combustible tobacco user/ former smoker
• Use of cigarettes for 15 days or more in the past 60 days
• Use of other tobacco products (cigars, hookah, smokeless), marijuana and/or illicit or prescription drugs weekly or more frequently in the past 60 days
• Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
• Disorder or use of medication that affects cardiopulmonary health
• Evidence of pregnancy or current nursing
• Non e-Cig using arm
• \- Between 18 and 29 years of age
• years old and younger or 30 years old and older
• Use of cigarettes or other tobacco products more than 50 times in their lifetime.
• Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders
• 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

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and breath condensate will be collected and stored and the department of Kinesiology and Health Sciences.

MeSH Terms

Conditions

Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Paula Rodriguez Miguelez

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Rodriguez Miguelez

CONTACT

(804) 396-4498; prodriguezmig@vcu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: July 14, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)