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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-24
SponsorUniversity of Iowa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

tobacco cigarette use (current or history of)

use of stimulant drugs

skin diseases

cardiovascular disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • Placebo

    Drug

    Oral placebo tablet

  • Salsalate 750 MG Oral Tablet [DISALCID]

    Drug

    Oral salsalate tablet

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Placebo then SalsalateExperimental treatment 2 interventions
Group B: Salsalate then PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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