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NCT06159608 · ClinicalTrials.gov registry record · Early Phase 1
Sex Differences in the Vascular Effects of E-cigarette Use
A Early Phase 1 study of E-cigarette Use, sponsored by Anna Stanhewicz, PhD.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06159608 is a Early Phase 1 study of E-cigarette Use that is actively recruiting participants, run by Anna Stanhewicz, PhD. The registered enrollment target is 80 participants, below the 198-participant average among 12 other E-cigarette Use trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06159608, a Early Phase 1 study of E-cigarette Use, is actively recruiting participants, sponsored by Anna Stanhewicz, PhD.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor)
- OTHER Chronic estrogen exposure
Study Locations (1)
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-12-02 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06159608
The ClinicalTrials.gov registry entry for NCT06159608 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 12 other E-cigarette Use trials with a reported enrollment target (60% lower). The listed sponsor is Anna Stanhewicz, PhD, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with E-cigarette Use appearing as the primary indexed condition, and to 2 interventions - of which Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor) is the first listed.
NCT06159608 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT06159608 about?
NCT06159608 is a clinical study titled "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 wit...
What is the current status of trial NCT06159608?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2023-12-02. Estimated completion is 2026-12.
What conditions does trial NCT06159608 study?
This clinical trial studies the following conditions: E-cigarette Use.
What interventions are being tested in trial NCT06159608?
The interventions under investigation include: Local heating + L-NAME (NG-nitro-L-arginine methyl ester; nitric oxide synthase inhibitor) (DRUG), Chronic estrogen exposure (OTHER).
Who is sponsoring clinical trial NCT06159608?
This trial is sponsored by Anna Stanhewicz, PhD, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06159608 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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