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Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids

NCT06619964 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-01-15

No results posted yet for this study

Summary

The goal of this observational study is to learn if electronic cigarette users who currently choose to use lower nicotine eliquids have reduced harm compared those who choose higher nicotine eliquids.

The main questions it aims to answer are:

* Do lower nicotine users actually consume less nicotine compared to higher nicotine users?
* Do lower nicotine users have lower amounts of harmful and potentially harmful constituent exposures compared to higher nicotine users?
* Do lower nicotine users perceive their choice of product to be less harmful than higher nicotine products? Researchers will monitor ecig users of different nicotine concentrations for two weeks in their natural environment to determine how much eliquid and nicotine they consumed, assess their daily mood and craving, and measure exposure and health effect.

Participants will:

* Complete surveys on history of tobacco use, nicotine dependence and perception.
* Use their electronic cigarette with their usual nicotine eliquid ad lib for two weeks in their natural environment.
* Complete daily questionnaires for mood and craving for two weeks in their natural environment.
* Collect three salivary samples at home, morning, afternoon and evening, each day for two weeks, in their natural environment.
* Use a topography monitor to record puffing behavior for every puff taken during week two, in their natural environment.
* Provide saliva, urine and blood samples in the lab at the end of each week.

Conditions

  • Nicotine Addiction

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Rochester

    collaborator OTHER

  • Rochester Institute of Technology

    lead OTHER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06619964 on ClinicalTrials.gov