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

University of Iowa

Status and phase: Enrolling; Early Phase 1

Conditions: Inflammation; Endothelial Dysfunction; Electronic Cigarette Use

Treatments: Drug: Salsalate 750 MG Oral Tablet [DISALCID]; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06489249

202405142

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Placebo then Salsalate

Experimental group

Description:

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.

Treatment:

Drug: Salsalate 750 MG Oral Tablet [DISALCID]

Drug: Placebo

Salsalate then Placebo

Experimental group

Description:

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.

Treatment:

Drug: Salsalate 750 MG Oral Tablet [DISALCID]

Drug: Placebo