NCT06610838 · University of Wisconsin, Madison
Effects of E-cigarette Use on Health
(VAPECHECK)
What this study is about
Electronic nicotine delivery systems (ENDS) are used by millions of Americans, however their long-term health effects are unknown. This research proposal will quantify the effects of long-term ENDS use on validated and novel biomarkers of cardiovascular and pulmonary disease and how they are influenced by use heaviness, age, body weight, and co-use of other products.
View original scientific description
Electronic nicotine delivery systems (ENDS) are used by millions of Americans, however their long-term health effects are unknown. This research proposal will quantify the effects of long-term ENDS use on validated and novel biomarkers of cardiovascular and pulmonary disease and how they are influenced by use heaviness, age, body weight, and co-use of other products. This study will produce the most informative evidence to date on how long-term ENDS use affects cardiovascular and pulmonary health.
Interventions
OTHER
Health Assessments
Participants will complete the blood tests, questionnaires, cardiovascular tests, and pulmonary test at visits 1, 2, and 4. Non-Contrast Chest CT and cardiopulmonary treadmill (VO2 max) stress tests will occur at visits 1 and 4. Visit 3 will not include cardiovascular and pulmonary tests.
Primary outcome measures
Change in mean common carotid artery intima-media thickness (CCA-IMT)
Time frame: Baseline to 3 years
Carotid ultrasound CCA-IMT measures the thickness of the carotid artery wall and is a measure of arterial injury. Rates of change vary by age, sex, and race, but less increase is associated with less cardiovascular disease risk.
Change in LAA-856
Time frame: Baseline to 3 years
Quantitative computed tomography (CT) can measure LAA-856 \[percent of lung voxels less than -856 HU\], which describes air trapping. Less air trapping indicates less progression of obstructive ventilation in and risk of obstructive lung diseases.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- greater than or equal to 21 years of age
- has vaped a nicotine e-cigarette product at least 2 days/week for most weeks for greater than or equal to 12 months
- plans to remain in catchment area for greater than or equal to 3 years
- smoked 5 or fewer tobacco cigarettes in the past 6 months
- no serious CV, pulmonary, or other medical problems
- not currently pregnant
- no plans to stop vaping
Exclusion criteria
- serious CV, pulmonary, or other medical problems (e.g., moderate or severe aortic stenosis, class III or IV heart failure, blood pressure greater than or equal to 160/100 mmHg, interstitial lung disease, sarcoidosis, Stage 3 or 4 cancer)
- combusted or vaped cannabis use 3 days/week or more in the past 3 months
- currently pregnant
- not able to read an write English
- incarceration
Where
- Madison, Wisconsin
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations