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

Conditions

• Electronic Cigarette Use
• Endothelial Dysfunction
• Inflammation

Eligibility Criteria

Sex

ALL

Age

18 Years - 24 Years

Healthy Volunteers

Accepted

Interventions

• Placebo — DRUG
  Oral placebo tablet
• Salsalate 750 MG Oral Tablet [DISALCID] — DRUG
  Oral salsalate tablet

Study Details

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.

Key Dates

Start date

Aug 15, 2024

Status verified

Dec 2025

Primary completion

Jun 30, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

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.

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

• Anna Stanhewicz, PhD
  3194671732
  [email protected]

Locations (2)

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