Recruiting
Early Phase 1

Observational Study

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT06159608

Conditions

E-cigarette Use

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Accepted

Interventions

Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor)

Chronic estrogen exposure

Study Details

Brief summary:

The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as "vaping" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored.

In this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a dime-sized area of the skin in otherwise healthy young (18-24yrs) chronic e-cigarette users. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, we also draw blood from the subjects to measure circulating factors that may contribute to cardiovascular health and examine markers of inflammatory activation. We will also collect urine from female participants to measure estradiol.

Conditions

E-cigarette Use

Study ID

NCT06159608

Start date

Dec 2, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-24 years old
  • one of the following:

1. have no history of e-cigarette use
2. be a current e-cigarette user who has been using e-cigarettes for 6 months or longer

Exclusion Criteria:

  • history of cardiovascular, metabolic, and/or skin diseases
  • body mass index >30 kg/m2
  • blood pressure ≥140 systolic and/or ≥ 90 diastolic
  • current or history of tobacco cigarette use
  • current antihypertensive or cholesterol-lowering medication
  • current use of cannabis, marijuana, and/or other illegal substances
  • current use of stimulant drugs
  • currently pregnant or breastfeeding
  • allergy to materials used during the experiment (e.g. latex),
  • known allergy to study drugs
  • healthy control subjects will also be excluded if they have ever used e-cigarettes in the past

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Healthy Young Women

Young women who do not use e-cigarettes

other: Healthy Young Men

Young men who do not use e-cigarettes

other: Young Women using E-cigarettes

Young women chronically use e-cigarettes

other: Young Men using E-cigarettes

Young men chronically use e-cigarettes

Interventions

Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor)

Differences in endothelium- and nitric oxide (NO)-dependent dilation between groups

Chronic estrogen exposure

differences in urine estrogen levels across the menstrual cycle between women groups only

Primary outcome measure

  • Change in microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry [ Time Frame: at the study visit, an average of 4 hours ]
  • monthly estrogen exposure [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2025-12-15.