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NCT Number: NCT06159608

Sex Differences in the Vascular Effects of E-cigarette Use

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.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Anna Stanhewicz

CONTACT

[email protected]

319-467-1732

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-24 years old
  • one of the following:
  • have no history of e-cigarette use
  • 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

Treatment and study plan

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

Drug

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

Chronic estrogen exposure

Other

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

Primary outcomes

  1. Change in microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry

    Time frame: at the study visit, an average of 4 hours

    cutaneous vascular vasodilator responses to local heating over a microdialysis fiber receiving lactated Ringer's solution, followed by L-NAME infusion to quantify NO-dependent response

  2. monthly estrogen exposure

    Time frame: 1 month

    daily estradiol levels will be measured in all women for 1 month/menstrual cycle

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Reid-Stanhewicz, PHD

CONTACT

[email protected]

319-467-1732

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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