Developing and Testing Health Warning Labels on the ENDS Device

Part of paid clinical trials in Miami, Florida.

Sponsor
Florida International University
Study ID
NCT04907136
Status
Recruiting
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Conditions

  • Electronic Cigarette Use

Eligibility Criteria

Sex
ALL
Age
21 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Preferred ENDS — OTHER
    Preferred ENDS without HWL on device
  • Preferred ENDS with HWL — OTHER
    Preferred ENDS with a HWL on device

Study Details

In this project, after systematically developing electronic nicotine delivery systems (ENDS) pictorial health warning labels (HWLs), a proven clinical lab model will be used to examine and test their effect when these are placed on the ENDS device on a variety of subjective (e.g. satisfaction, harm perception, nicotine dependence, intention to quit) and objective outcomes (e.g. plasma nicotine, puff topography) in young adults.

Key Dates

Start date
Dec 13, 2023
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Preferred ENDS
    All participants will complete a lab visit where they will use their preferred ENDS ad libitum for up to 60 minutes
  • Experimental: Preferred ENDS with HWL
    All participants will complete a lab visit where they will use their preferred ENDS with a HWL on the device ad libitum for up to 60 minutes

Primary Outcome Measure

Plasma nicotine [ Time Frame: During the 2 participant visits. Blood will be taken 2 times in each ENDS use session: before and after an approximately 60-min ad lib use period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida International UniversityMiamiFlorida33199
Katherine Pita, BSN
[email protected]
786-209-9642

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By research site
Florida International University· Miami, FL

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