Electronic Cigarette UseEarly Phase 1NCT06489249
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
A Early Phase 1 study testing Salsalate 750 MG Oral Tablet [DISALCID] in people with Electronic Cigarette Use and Endothelial Dysfunction, run by University of Iowa at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use, Endothelial Dysfunction, Inflammation
- What is being tested?
- Salsalate 750 MG Oral Tablet [DISALCID]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2024to Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Iowa Bioscience Innovation Facility
Iowa City, Iowa, 52242
Anna Stanhewicz, P.h.D, 319-467-1732, anna-stanhewicz@uiowa.edu
Claire Goebel, B.S., 319-335-1914, cgoebl@uiowa.edu
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Anna Stanhewicz, PhD, 319-467-1732, anna-stanhewicz@uiowa.edu
About this study
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.
- Being tested
- Placebo, Salsalate 750 MG Oral Tablet [DISALCID]
- Medical subject headings
- Vaping, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral placebo tablet
Salsalate 750 MG Oral Tablet [DISALCID]Drug
Oral salsalate tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: Salsalate 750 MG Oral Tablet [DISALCID] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start15 Aug 2024
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Stanhewicz, PhD, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489249
- Sponsor's protocol ID
- 202405142
- Status last verified
- Oct 2026
- First submitted
- 28 Jun 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
- ClinicalTrials.gov ID
- NCT06489249
- Acronym / sponsor ID
- 202405142
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo then Salsalate | Experimental | Drug: Placebo, Drug: 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. |
| Salsalate then Placebo | Experimental | Drug: Placebo, Drug: 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (11 listed)
- tobacco cigarette use (current or history of)
- use of stimulant drugs
- skin diseases
- cardiovascular disease
- diagnosed or suspected hepatic or metabolic disease including diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral placebo tablet | Drug | Placebo then Salsalate, Salsalate then Placebo |
| Salsalate 750 MG Oral Tablet [DISALCID]Oral salsalate tablet | Drug | Placebo then Salsalate, Salsalate then Placebo |
Primary outcome
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Salsalate 750 MG Oral Tablet [DISALCID] in people with Electronic Cigarette Use and Endothelial Dysfunction, run by University of Iowa at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Stanhewicz, PhD (3194671732, anna-stanhewicz@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.