Recruiting

E-Cigarette Use

Sponsor:

University of Wisconsin, Madison

Code:

NCT06610838

Conditions

Electronic Cigarette Use

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Health Assessments

Study Details

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

Study ID

NCT06610838

Start date

Jan 6, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

ENDS users

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

Non-users

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

Interventions

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 measure

  • Change in mean common carotid artery intima-media thickness (CCA-IMT) [ Time Frame: Baseline to 3 years ]
  • Change in LAA-856 [ Time Frame: Baseline to 3 years ]

Central Contacts and Locations

Central contacts

James Stein, MD

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

Timothy Baker, PhD

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

Locations

UW Center for Tobacco Research and Intervention

Recruiting

Madison, Wisconsin, United States, 53711

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2025-12-24.