Clinical trial NCT06610838: Effects of E-cigarette Use on Health
Official title: Longitudinal Effects of E-cigarette Use on Cardiovascular and Pulmonary Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Electronic Cigarette Use
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-09-24
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants enrolled will comprise a large group of exclusive ENDS users who do not use combusted cigarettes and who have used ENDS regularly for at least 1 year. ENDS participants must have vaped at least 4 days/week for greater than or equal to 12 months, smoke very infrequently, and have no plans to try to stop vaping in the foreseeable future. The comparison non-user group also will be gender-matched and comprise those who report no vaping or smoking in the past 6 months and less than 5 times in 2 years.

Brief summary: 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.

Detailed description: Electronic nicotine delivery systems (ENDS) are used by millions of Americans, however, their long-term health effects are unknown. Although ENDS use delivers far lower levels of carcinogens than tobacco smoking, very little is known about whether ENDS use affects the risks of developing cardiovascular (CV) or pulmonary diseases, two of the most highly prevalent causes of morbidity and mortality in the United States. This research proposal will quantify the effects of long-term ENDS use on validated and novel biomarkers of CV and pulmonary disease and how they are influenced by use heaviness, age, body weight, and co-use of other products. This research also will shed additional light on long-term ENDS use patterns and ENDS dependence. The importance of this study does not rest upon demonstrating adverse effects of ENDS use.

The study team will recruit up to 400 long-term, stable users of ENDS and up to 200 age- and gender-matched control participants who do not use ENDS or combustible cigarettes. They will undergo comprehensive biomarker assessments over 36 months. Biomarkers assess CV and pulmonary health status and risk and include vital signs, blood samples for systemic inflammation and oxidative stress, lipids, and markers of insulin resistance and cardiometabolic health. Arterial structure changes will be assessed using carotid ultrasound. Sympathetic nervous system activation will be assessed by heart rate variability and arterial diameters. For pulmonary measures, the study team will obtain non-contrast quantitative computed tomography (CT) images to assess air trapping and texture-based measures of inflammation. The researcher also will perform spirometry. Integrated cardiopulmonary health will be assessed via treadmill stress testing. Other measures will include exhaled carbon monoxide, real-time measures of nicotine product use, nicotine dependence, and use of cannabis and alcohol. Biomarker status over time will be compared across groups and related to ENDS use heaviness, use of other products, and person factors (i.e., age, gender, race/ethnicity, weight, and smoking history). About 130 participants who were phenotyped from 2019-2021 will be included.

The Primary Aim is to determine relationships between ENDS use heaviness and changes in our CV and pulmonary health biomarkers over 3 years. Biomarker status across ENDS users and non-users over time will be compared and associations between biomarker status and ENDS use heaviness within the ENDS user group will be examined.

The Secondary Aim is to characterize changes in ENDS use patterns and dependence over time and to determine how these are related to biomarker status changes and how they are influenced by the person factors described above. The primary and secondary CV measures are changes in common carotid artery intima-media thickness (CCA IMT) and grayscale median (GSM). The primary and secondary pulmonary measures are the changes in the quantitative CT measures of air trapping and parenchymal texture. This proposal will produce the most informative evidence to date on how long-term ENDS use affects CV and pulmonary health and disease risk.

Eligibility criteria: Inclusion Criteria:

* greater than or equal to 21 years of age
* has vaped a nicotine e-cigarette product at least 4 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

Primary outcomes:
measure: Change in mean common carotid artery intima-media thickness (CCA-IMT)
timeFrame: Baseline to 3 years
measure: Change in LAA-856
timeFrame: Baseline to 3 years
Secondary outcomes:
measure: Change in common carotid artery intima-media Grayscale Median (GSM)
timeFrame: Baseline to 3 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Center for Tobacco Research and Intervention
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References: