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

Enrolling by invitation

Conditions studied: Nicotine Addiction

In brief

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.

Key facts

Study ID

NCT06619964

Run by

Rochester Institute of Technology

People needed

120

Starts

2024-11-05

Expected to finish

2029-02-28

Last updated by the study team

2026-01-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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