Recruiting
Early Phase 1

Inflammation

Sponsor:

University of Iowa

Code:

NCT06489249

Conditions

Electronic Cigarette Use

Endothelial Dysfunction

Inflammation

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Accepted

Interventions

Placebo

Salsalate 750 MG Oral Tablet [DISALCID]

Study Details

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.

Conditions

Electronic Cigarette Use

Endothelial Dysfunction

Inflammation

Study ID

NCT06489249

Start date

Aug 15, 2024

Status verified date

Dec, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Placebo

Oral placebo tablet

Salsalate 750 MG Oral Tablet [DISALCID]

Oral salsalate tablet

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Iowa Bioscience Innovation Facility

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

University of Iowa

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-12-15.