Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
- Conditions
- Nicotine Addiction
- Registration Number
- NCT06619964
- Lead Sponsor
- Rochester Institute of Technology
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 120
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean daily salivary cotinine 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rochester Institute of Technology
🇺🇸Rochester, New York, United States