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Corticosteroid

Salsalate for Vaping-Related Inflammation

Phase < 1

Waitlist Available

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 - 24 years of age

Be between 18 and 65 years old

Must not have

Diagnosed or suspected hepatic or metabolic disease including diabetes

Known allergies to salsalate or other study drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Summary

This trial aims to investigate the effects of e-cigarette (vaping) use on young adults' cardiovascular health. The study will focus on how inflammation plays a role in the dysfunction of blood vessels caused

Who is the study for?

This trial is for young adults who currently use e-cigarettes ('vape'). Participants should not be tobacco smokers and must have no history of cardiovascular disease. The study aims to understand the impact of vaping on blood vessel function and inflammation.

What is being tested?

The trial is testing whether Salsalate, an anti-inflammatory medication, can improve blood vessel function in vapers compared to a placebo (a pill with no active drug). It's designed to see if reducing inflammation benefits vascular health in e-cigarette users.

What are the potential side effects?

Salsalate may cause side effects like digestive upset, ringing in the ears, or allergic reactions. Since it's related to aspirin, similar precautions apply. Placebo pills typically don't cause side effects but mimic taking actual medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 24 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or might have liver disease or diabetes.

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I am allergic to salsalate or similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Salsalate then PlaceboExperimental Treatment2 Interventions

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.

Group II: Placebo then SalsalateExperimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met