Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Salsalate 750 MG Oral Tablet [DISALCID].
- Who it may be relevant to
- Registry conditions: Electronic Cigarette Use, Endothelial Dysfunction, Inflammation. Basic parameters: 18 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Placebo
Oral placebo tablet - Drug Salsalate 750 MG Oral Tablet [DISALCID]
Oral salsalate tablet
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Iowa Bioscience Innovation Facility — Iowa City
- University of Iowa — Iowa City
Identifiers
NCT: NCT06489249 · 202405142