Sex Differences in the Vascular Effects of E-cigarette Use
Anna Stanhewicz, PhD · NCT06159608
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Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–24 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Early Phase 1
- Target enrollment
- 80
- US sites recruiting
- 1
- Study start
- December 2, 2023
- Record last updated
- December 15, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor); Chronic estrogen exposure
Conditions: E-cigarette Use
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
University of Iowa
Iowa City, IA 52242
Site contact: Anna Stanhewicz · 319-467-1732 · anna-stanhewicz@uiowa.edu
Study contacts (from the official record)
- Anna Reid-Stanhewicz, PHD · 319-467-1732 · anna-stanhewicz@uiowa.edu
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All smoking & vaping studies in Iowa →- RecruitingHealthy volunteersEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
University of Iowa
- Location
- Iowa City, IA + 1 other US site
- Eligibility basics
- Ages 18–24