About this trial
Goal: Investigate the health effects of electronic cigarettes (e-cigarettes) and whether a short break from using them can improve health.
Participants:
Up to 148 people (74 who use e-cigarettes and 74 who don't) Age and sex will be matched between the groups.
Study Design:
Two connected studies:
Observational Study: Compares general health (including lung function, heart health, blood pressure, and inflammation) of e-cigarette users to non-smokers.
Clinical Trial: E-cigarette users will be randomly assigned to either:
Take a 7-day break from e-cigarettes (intervention group) Continue using e-cigarettes as usual (control group) Both groups will have their health measured before and after the 7-day period. Main Outcome: How well your heart and lungs work during exercise.
Other Outcomes: Lung function, blood vessel function, risk factors for heart disease, and body measurements.
Why is this study important?
E-cigarettes are becoming more popular, but their health effects are unknown. This study will provide new information on whether e-cigarettes harm your health and if quitting for a short time can improve it.
This information can be used to create better public health policies about e-cigarettes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
14 years of age or older
Reporting using nicotine electronic cigarettes (e-cigarettes)
Serum cotinine levels equal to or greater than 3 ng/mL
Disqualifiers
Contraindications for maximum exercise testing or any of study procedures
Use of any smoking product except e-cigarette (combustible cigarette, cigar, hookah, marijuana, etc.)
Trial design
Parallel
Treatments tested in this trial
Pause
Behavioral7 days of no e-cigarette consumption
Treatment groups
Trial outcomes
Primary outcomes
Maximal oxygen consumption
Maximal cardiorespiratory fitness assessed in a treadmill test
Maximal oxygen consumption
Maximal cardiorespiratory fitness assessed in a treadmill test
Secondary outcomes
Pulmonary function
Assessed through spirometry analysis of flow volume loops patterns
Pulmonary function
Assessed through spirometry analysis of flow volume loops patterns
Endothelial function
Assessed through ultrasonography of brachial artery
Endothelial function
Assessed through ultrasonography of brachial artery
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: