Vaping for Vascular Injury

(ENDS Trial)

Overseen By Adam Wanner, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Smoking, Asthma, COPD, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how vaping affects blood vessels, particularly in the lungs, and whether it causes early damage. Researchers seek to understand if stopping vaping (vaping cessation) can prevent or reduce this damage. Suitable participants include those who have used electronic cigarette Puff Bars with 5% nicotine for at least six months. The trial also requires individuals who have never smoked or vaped to join a comparison group. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on vaping's health effects.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that vaping cessation is likely to be safe for humans?

Research has shown that quitting vaping, or stopping the use of e-cigarettes, can be safe and effective. One study found that cytisinicline may help people quit vaping without major safety issues, as participants did not report many serious side effects.

Overall, quitting vaping can improve health. Vaping harms the heart and lungs, even if it is less harmful than smoking regular cigarettes. Stopping vaping can help lower these health risks.

These findings suggest that efforts to quit vaping, including treatments like cytisinicline, are generally well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about vaping cessation for detecting vascular diseases early because it directly targets the root cause of potential vascular damage, unlike other treatments that often focus on managing symptoms after the damage has occurred. Vaping cessation addresses the addiction and exposure to harmful substances that contribute to vascular problems, potentially preventing disease progression before it starts. This proactive approach could lead to significant reductions in the risk of developing serious vascular conditions, offering a preventive strategy rather than a reactive one.

What evidence suggests that vaping cessation might be effective for preventing early damage in lung vessels?

Research has shown that quitting vaping can improve health, particularly for the lungs and blood vessels. One review found that people who received help to stop vaping were more likely to quit for at least a week to a year compared to those without support. Another study found that nearly half of young adults who used a quitline stopped vaping after three months. These findings suggest that quitting vaping could help reduce early damage to lung vessels, which this study aims to investigate. ^{3 6 7 8 9}

Who Is on the Research Team?

Adam Wanner, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

Current electronic cigarette (EC) Puff Bar users defined as using EC either daily or occasionally in the past 30 days for at least 6 months, and with 5% nicotine concentration pods.

Healthy never smokers, never vapers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Participants undergo assessments to measure pulmonary vascular resistance, flow-mediated vasodilation, and airway blood flow reactivity

4 weeks

Multiple visits for assessments

Follow-up

Participants are monitored for any changes in vascular health after initial assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vaping Cessation

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4752870/

E-cigarettes and smoking cessation in real-world ... Odds of quitting cigarettes were 28% lower in those who used e-cigarettes compared with those who did not use e-cigarettes (odds ratio 0·72, 95% CI 0·57–0·91).

2. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2025/02/20/tc-2024-058798

Vaping cessation interventions: a systematic review and ... Vaping cessation interventions increase 7-day PPA rates at 1–12 months follow-up and this was consistent across prespecified subgroup analyses.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2308815

Electronic Nicotine-Delivery Systems for Smoking Cessation The addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking ...

4. ajpmonline.org ajpmonline.org/article/S0749-3797(24)00371-4/fulltext

Quitline-Based Young Adult Vaping Cessation This quitline-delivered intervention was successful at helping young adults quit vaping, with almost half abstinent after 3 months.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821816

E-Cigarette Characteristics and Cigarette Cessation ... This cohort study uses data from the Population Assessment of Tobacco and Health (PATH) Study to investigate the association of e-cigarette.

6. cdc.gov cdc.gov/tobacco/e-cigarettes/health-effects.html

Health Effects of Vaping | Smoking and Tobacco Use No tobacco products, including e-cigarettes, are safe. · Most e-cigarettes contain nicotine, which is highly addictive and is a health danger for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11074928/

Cytisinicline for Vaping Cessation in Adults: ORCA-V1 Trial Cytisinicline is a potentially effective and safe pharmacotherapy for vaping cessation in adults who use nicotine e-cigarettes and seek to quit vaping.

8. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/full/10.1002/jac5.70092

Evidence Regarding E‐Cigarettes as a Harm Reduction ... Current evidence suggests e-cigarettes may be efficacious as a harm reduction tool for those not yet ready to completely abstain from nicotine.

9. hopkinsmedicine.org hopkinsmedicine.org/health/wellness-and-prevention/5-truths-you-need-to-know-about-vaping

5 Vaping Facts You Need to Know 5 Vaping Facts You Need to Know · 1: Vaping is less harmful than smoking, but it's still not safe. · 2: Research suggests vaping is bad for your heart and lungs.