Effects of E-cigarette Use on Health

NCT06610838 | Recruiting DMC

• 5 other identifiers: 2024-06841R01HL175602-01A534253SMPH/MEDICINE/GEN INT MDProtocol Version 10/23/25
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Electronic Cigarette Use

Outcome Measures

Primary Outcomes (2)

• Change in mean common carotid artery intima-media thickness (CCA-IMT)

  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.

  Baseline to 3 years

• Change in LAA-856

  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.

  Baseline to 3 years

Secondary Outcomes (1)

• Change in common carotid artery intima-media Grayscale Median (GSM)

  Baseline to 3 years

Study Arms (2)

ENDS users

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

Other: Health Assessments

Non-users

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

Other: Health Assessments

Interventions

Health Assessments 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.

ENDS users; Non-users

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 2 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

UW Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

RECRUITING

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Timothy Baker, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Stein, MD

CONTACT

608-262-2075; jhs@medicine.wisc.edu

Timothy Baker, PhD

CONTACT

503-387-5167; tbb@ctri.wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 24, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The study team will submit processed and cleaned data to the Biologic Specimen and Data Repository (BioLINCC) approximately 3 months prior to any publication date or 3 months after the end of the performance period, whichever is sooner. Data will be available indefinitely (i.e., for as long as the BioLINCC repository is maintained or chooses to continue to archive our study data).
• Access Criteria: Data will be shared with controlled access in BioLINCC for general research use, as allowed by the participant's informed consent agreement and the Institutional Certification.

Locations

US (1)