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

NCT06489249 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 202405142
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Electronic Cigarette Use; Endothelial Dysfunction; Inflammation

Outcome Measures

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).

  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

Study Arms (2)

Placebo then Salsalate

EXPERIMENTAL

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.

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

Salsalate then Placebo

EXPERIMENTAL

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.

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

Interventions

Placebo DRUG

Oral placebo tablet

Placebo then Salsalate; Salsalate then Placebo

Salsalate 750 MG Oral Tablet [DISALCID] DRUG

Oral salsalate tablet

Placebo then Salsalate; Salsalate then Placebo

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• no history of e-cigarette use (control) OR current with 6 months or more history of e-cigarette use (chronic use).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (2)

Iowa Bioscience Innovation Facility

Iowa City, Iowa, 52242, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Vaping; Inflammation

Interventions

salicylsalicylic acid; Tablets

Condition Hierarchy (Ancestors)

Smoking; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Anna Stanhewicz, PhD

CONTACT

3194671732; anna-stanhewicz@uiowa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)