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Developing and Testing Health Warning Labels on the ENDS Device

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Mar 30, 2026, no change to tracked fieldsv12-v13
  2. Enrollment target: 210 to 80
    • Primary completion date: Apr 30, 2026 to Dec 30, 2026
    • Study completion date: Apr 30, 2026 to Apr 30, 2027
    • Eligibility criteria shortened, about 7 words
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2023 to Dec 13, 2023
    • Site details revised
    v9
  5. Start date: Aug 1, 2023 to Dec 1, 2023v8
Show 6 earlier versionsHide 6 earlier versions
  1. Secondary endpoints: 7 to 11
    • Eligibility criteria expanded, about 1 word
    v7
  2. Phase: Phase 4 to Not applicable
    • Start date: Mar 1, 2023 to Aug 1, 2023
    v6
  3. Start date: Sep 1, 2022 to Mar 1, 2023v5
  4. Phase: Not applicable to Phase 4v4
  5. Start date: Jun 1, 2022 to Sep 1, 2022v3
  6. Study description expanded, about 3 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04907136
Lead Sponsor Florida International University
Collaborators: University of Miami
Conditions
(from sponsor)		 Electronic Cigarette Use
Related terms Vaping
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov