Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06489249

Role of Inflammation in Vascular Phenotype Associated With 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. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Iowa Bioscience Innovation Facility, Iowa City, Iowa, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Placebo

Drug

Oral placebo tablet

Salsalate 750 MG Oral Tablet [DISALCID]

Drug

Oral salsalate tablet

Primary outcomes

  1. Microvascular endothelial function (Cutaneous conductance, %maximum) following salsalate treatment compared to placebo treatment

    Time frame: a 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 treatment

    Endothelium-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).

Study contacts

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

Anna Stanhewicz, PhD

CONTACT

[email protected]

3194671732

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
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.

Published trials that share one or more normalized conditions with this study.