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

Part of paid clinical trials in Rochester, New York.

Sponsor
Rochester Institute of Technology
Study ID
NCT06619964
Status
Enrolling By Invitation

Conditions

  • Nicotine Addiction

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Nov 5, 2024
Status verified
Jan 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
120 participants (estimated)

Primary Outcome Measure

Mean daily salivary cotinine [ Time Frame: From enrollment to the end of observation at 2 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rochester Institute of TechnologyRochesterNew York14623-

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