Clinical trial NCT06619964: Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
Official title: Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nicotine Addiction
Keywords: electronic cigarettes
nicotine addiction
eliquid nicotine concentration
perception of risk
health effects
biomarkers of exposure
subjective affect
Lead sponsor: Rochester Institute of Technology
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Rochester
First posted: 2024-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residence of the Greater Rochester, NY area

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean daily salivary cotinine
timeFrame: From enrollment to the end of observation at 2 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester Institute of Technology
state: New York
Study officials:
References: