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Effects of E-cigarette Use on Health

NCT ID: NCT06610838

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-06

Study Completion Date

2029-06-30

Brief Summary

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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

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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.

Conditions

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Electronic Cigarette Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ENDS users

Long-term stable users of electronic nicotine delivery systems, 21 years of age or older, who do not use combustible (conventional) cigarettes

Health Assessments

Intervention Type OTHER

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.

Non-users

Gender-matched control participants who do not use ENDS or combustible cigarettes

Health Assessments

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Baker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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UW Center for Tobacco Research and Intervention

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James Stein, MD

Role: CONTACT

Phone: 608-262-2075

Email: [email protected]

Timothy Baker, PhD

Role: CONTACT

Phone: 503-387-5167

Email: [email protected]

Other Identifiers

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1R01HL175602-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534253

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/GEN INT MD

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 10/23/25

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0684

Identifier Type: -

Identifier Source: org_study_id