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

Early Phase 1

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Salsalate then Placebo	Salsalate 750 MG Oral Tablet [DISALCID]	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.
Salsalate then Placebo	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.
Placebo then Salsalate	Placebo	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.
Placebo then Salsalate	Salsalate 750 MG Oral Tablet [DISALCID]	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Locations (2): Iowa Bioscience Innovation Facility
🇺🇸
Iowa City, Iowa, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States

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