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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Electronic Cigarette Use; Endothelial Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: Salsalate 750 MG Oral Tablet [DISALCID]

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Anna Stanhewicz, PhD; Phone Number: 3194671732; Email: anna-stanhewicz@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Anna Stanhewicz, PhD; Phone Number: 319-467-1732; Email: anna-stanhewicz@uiowa.edu
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • Iowa Bioscience Innovation Facility
      • Contact: Anna Stanhewicz, P.h.D; Phone Number: 319-467-1732; Email: anna-stanhewicz@uiowa.edu
      • Contact: Claire Goebel, B.S.; Phone Number: 319-335-1914; Email: cgoebl@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo then Salsalate; Placebo oral table twice daily for 4 days prior to experimental testing followed by 14 day washout period and then salsalate oral tablet 1500mg twice daily for 4 days prior to experimental testing.	Drug: Placebo; Oral placebo tablet; Drug: Salsalate 750 MG Oral Tablet [DISALCID]; Oral salsalate tablet
Experimental: Salsalate then Placebo; Salsalate oral tablet 1500mg twice daily for 4 days prior to experimental testing followed by 14 day washout period and then placebo oral tablet twice daily for 4 days prior to experimental testing.	Drug: Placebo; Oral placebo tablet; Drug: Salsalate 750 MG Oral Tablet [DISALCID]; Oral salsalate tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular endothelial function (Cutaneous conductance, %maximum) following salsalate treatment compared to 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).	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

Collaborators and Investigators

• Sponsor: University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Smoking; Inflammation; Vaping; Pharmaceutical Preparations; Dosage Forms; Tablets; salicylsalicylic acid
• Other Study ID Numbers: 202405142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No