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OpenTrials
Enrolling by Invitation

NCT Number: NCT06619964

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

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.

Enrolling by Invitation

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rochester Institute of Technology

Rochester, New York, 14623, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rochester Institute of Technology

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Rochester

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 1, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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