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

January 13, 2026 updated by: Risa Robinson, Rochester Institute of Technology

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14623
        • Rochester Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Residence of the Greater Rochester, NY area

Description

Inclusion Criteria:

  • Age 21 yrs or older
  • Pod-style or pen-style users, not adjustable for power or airflow, nicotine greater than 0 mg/mL
  • Current everyday users
  • Use history of at least 30 days
  • No current use of combustible tobacco product, or nicotine replacement therapy
  • CO less than 6 ppm at intake
  • No plans to quit tobacco use in the next 30 days

Exclusion Criteria:

  • History of acute or chronic asthma
  • Previous diagnosis of cancer
  • Other chronic medical conditions
  • Use of chronic prescription medications
  • Pneumonia in prior six weeks
  • Upper respiratory tract infection or other febrile illness in previous 2 weeks
  • On antioxidants or anti-inflammatory therapy
  • Pregnant women or women who intend to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean daily salivary cotinine
Time Frame: From enrollment to the end of observation at 2 weeks.
Nicotine exposure as indicated by mean daily salivary cotinine will be compared for lower versus higher nicotine strength regular ecig users, on a continuous scale. This will determine the extent to which reduced nicotine products result in lower nicotine exposure.
From enrollment to the end of observation at 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochester Institute of Technology

Collaborators

National Institute on Drug Abuse (NIDA)
University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2024

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

September 28, 2024

First Submitted That Met QC Criteria

September 28, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DA057687 (U.S. NIH Grant/Contract)
  • 1R01DA057687-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nicotine Addiction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe