Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619964
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None