E-Cigarette Liquids for Cardiopulmonary Health

Overseen By Paula Rodriguez Miguelez, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Virginia Commonwealth University

Must not be taking: Cardiopulmonary medications

Disqualifiers: Cardiovascular, Pulmonary, Renal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how e-cigarettes affect heart and lung health. Participants will use different types of tobacco-flavored e-liquid, such as Tobacco flavored liquid type 1 and Tobacco flavored liquid type 2, or abstain from e-cigarettes, to observe any changes in cardiopulmonary health. The trial seeks individuals who have used e-cigarettes at least three times a week for the past three months. Those who meet this criterion and wish to learn more about the health effects of e-cigarettes may find this trial suitable. As an Early Phase 1 trial, this research focuses on understanding the health impacts of e-cigarettes, offering participants a chance to contribute to groundbreaking insights.

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

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that affect heart and lung health.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that e-cigarettes, including those with tobacco-flavored liquids, contain harmful substances. Studies indicate that using these devices can slightly increase blood pressure and heart rate. For example, one review found a small rise in blood pressure (2 mm Hg) and heart rate (2 beats per minute) after using e-cigarettes with nicotine.

E-cigarettes also release potentially harmful chemicals that can affect the lungs and may raise the risk of lung problems. Notably, people who use both traditional cigarettes and e-cigarettes might face a higher risk of lung cancer than those who only smoke traditional cigarettes.

This trial is in its early stages and primarily aims to assess the safety of these e-cigarette liquids. Currently, there is limited safety data from users of these specific products. However, the early phase of the trial involves researchers evaluating how well participants tolerate these liquids. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for cardiopulmonary health issues focus on medication or lifestyle changes, but this trial is exploring the impact of different tobacco-flavored e-cigarette liquids. Researchers are excited because these e-liquids might offer a less harmful alternative for smokers, potentially reducing the negative effects on heart and lung health. Unlike standard nicotine replacement options, this study explores if variations in e-liquid composition can play a role in harm reduction for smokers, which could lead to new insights and options for improving cardiopulmonary health.

What evidence suggests that this trial's treatments could be effective for cardiopulmonary health?

This trial will compare the effects of two different e-cigarette liquids on cardiopulmonary health. Research has shown that e-cigarettes, even those with tobacco flavors, can help people quit smoking regular cigarettes, achieving better success rates than some other methods. However, no evidence suggests that e-cigarettes improve heart health. In fact, studies have linked e-cigarette use to blood vessel damage and increased oxidative stress, which can harm cells. Additionally, studies highlight various health risks, such as nicotine poisoning and possible lung damage. While e-cigarettes might assist in quitting smoking, their overall effects on heart and lung health remain unclear. ^{2 6 7 8 9}

Who Is on the Research Team?

Paula Rodriguez Miguelez, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults over the age of 21 who are either regular e-cigarette users (using them at least three times a week for more than three months) or those who have never used e-cigarettes. It's not specified, but typically people with certain health conditions may be excluded.

Inclusion Criteria

I am 21 or older and do not use e-cigarettes.

I am 21 or older and have been using e-cigarettes regularly for at least 3 months.

Exclusion Criteria

Use of cigarettes for 15 days or more in the past 60 days

I have heart, lung, kidney, liver, metabolic, or brain diseases.

Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use assigned e-cigarette products or abstain from use for 2 weeks

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tobacco flavored liquid type 1
• Tobacco flavored liquid type 2

Trial Overview The study is testing two types of tobacco-flavored liquids used in cartridge-based electronic cigarettes to see how they affect the heart and lungs of the users. Participants will use these liquids and their cardiopulmonary health will be monitored.

How Is the Trial Designed?

Group I: E-cigarette liquid type 1 Experimental Treatment 1 Intervention

Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period.

Group II: E-cigarettes liquid type 2 Active Control 1 Intervention

Participants will be instructed to use at least one study product daily in place of their own e-cigarettes during the intervention period.

Group III: No e-cigarettes Active Control 1 Intervention

No e-cigarette use

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001160

Cardiopulmonary Impact of Electronic Cigarettes and ... Vaping can cause a wide array of severe adverse health effects that include nicotine poisoning, trauma from device battery explosions, and injury to the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8820458/

E-cigarettes and cardiopulmonary health: A review for clinicians In clinical trials, use of electronic cigarettes improves smoking cessation rates (OR = 1.529 [95% CI: 1.158 to 2.019]) compared to conventional therapies.

3. stacks.cdc.gov stacks.cdc.gov/view/cdc/127784/cdc_127784_DS1.pdf

Electronic Nicotine Delivery Systems and Cardiovascular Vanilla and tobacco flavored e-cig liquids showed a greater overall increase in ROS levels than apple/mint flavored e-liquid. Vanilla and ...

4. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2025/05/08/tc-2024-059019.full

Electronic cigarette use, related health outcomes and ... E-cigarette use is associated with several adverse acute health outcomes; there is currently insufficient longitudinal evidence to predict chronic health ...

5. truthinitiative.org truthinitiative.org/research-resources/emerging-tobacco-products/e-cigarettes-facts-stats-and-regulations

E-cigarettes: Facts, stats and regulations To date, there is no available evidence to suggest that e-cigarette use is associated with clinical cardiovascular outcomes such as coronary heart disease, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9590402/

Pulmonary effects of e-liquid flavors: a systematic review The aim of this review was to assess evidence from 38 reports on the adverse effects of flavored e-liquids on the respiratory system in both in vitro and in ...

7. lung.org lung.org/quit-smoking/e-cigarettes-vaping/impact-of-e-cigarettes-on-lung

Health Risks of E-Cigarettes and Vaping Using e-cigarettes causes health risks. It concluded that e-cigarettes both contain and emit a number of potentially toxic substances.

8. hopkinsmedicine.org hopkinsmedicine.org/health/wellness-and-prevention/what-does-vaping-do-to-your-lungs

What Does Vaping Do to Your Lungs? Many people wonder if vaping is bad for your lungs. Find out from an expert how it impacts lungs and which illnesses are associated with vaping.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7948134/

E-Cigarettes and Cardiopulmonary Health - PMC As discussed before, nicotine levels are ∼50-fold lower in plasma after use of e-cigarettes, snus, or tobacco than in the lung after tobacco or e-cigarette ...