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Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use

Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06489249
Enrollment
24
Registered
2024-07-05
Start date
2024-08-15
Completion date
2026-10-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electronic Cigarette Use, Endothelial Dysfunction, Inflammation

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. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.

Interventions

DRUGPlacebo

Oral placebo tablet

DRUGSalsalate 750 MG Oral Tablet [DISALCID]

Oral salsalate tablet

Sponsors

University of Iowa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 - 24 years of age * no history of e-cigarette use (control) OR current with 6 months or more history of e-cigarette use (chronic use).

Exclusion criteria

* tobacco cigarette use (current or history of) * use of stimulant drugs * skin diseases * cardiovascular disease * diagnosed or suspected hepatic or metabolic disease including diabetes * statin or other cholesterol-lowering medication * antihypertensive medication * current pregnancy or breastfeeding * blood pressure greater than or equal to 140mmHg systolic and/or greater than or equal to 90mmHg diastolic * allergy to materials used during the experiment * known allergies to salsalate or other study drugs

Design outcomes

Primary

MeasureTime frameDescription
Microvascular endothelial function (Cutaneous conductance, %maximum) following salsalate treatment compared to placebo treatmenta total of 2 times throughout the study (approximately 4 weeks): 1) at the completion of 4 days of oral salsalate treatment, and 2) at the completion of 4 days of placebo treatmentEndothelium-dependent vasodilation assessed as cutaneous conductance response (cutaneous conductance = local red blood cell flux/mean arterial pressure; %maximum) to local heating of the skin (42 degrees Celcius).

Countries

United States

Contacts

Primary ContactAnna Stanhewicz, PhD
anna-stanhewicz@uiowa.edu3194671732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026