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NCT05317663 · ClinicalTrials.gov registry record · NA

Developing and Testing Waterpipe-specific Health Warning Labels

A NA study, sponsored by Florida International University.

Completed
Registry status
NA
Development phase
44
Enrollment target

NCT05317663: Completed NA study, sponsored by Florida International University.

NCT05317663 is a NA study that has completed, run by Florida International University. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05317663, a NA study, has completed, sponsored by Florida International University.

COMPLETED
Registry status
NA
Development phase
44 participants
Enrollment target

Study Summary

Waterpipe (WP) smoking has become one of the leading tobacco use methods among youth in Florida. The impact of this dramatic rise is amplified by the mounting evidence of WP addictive and harmful nature, as well as the lag of policy response to it. Evidence suggests WP use leads to nicotine addiction, and increases the risk of lung cancer, heart and respiratory disease and exposure to secondhand smoke. The spread of WP use among youth has been fueled by a misperception of reduced-harm compared to cigarettes. Health Warning Labels (HWLs) represent one of the most successful tobacco control strategies to communicate smoking- related risks, and studies have consistently shown that HWLs are associated with a decrease in smoking rates and smoking-related morbidity and mortality. Therefore, communicating WP risks to young people through HWLs has been identified as a priority by major health bodies in the US including the FDA. Using the Delphi method among international tobacco control experts, our team has developed a set of 12 WP HWLs corresponding to 4 health themes; health risks/addiction, harm to others, WP-specific harm, WP harm compared to cigarettes. Building on this work, and using a mixed- method approach incorporating qualitative and quantitative research, the investigators propose to: Aim 1: Adapt the 12 HWLs to young WP smokers in Florida using exploratory focus groups. Aim 2: Test in a clinical lab experiment the performance of the top 4 HWLs on the WP device compared to no-HWL/control on harm perception, intention to quit, and toxicant exposure (Carbon monoxide (CO), nicotine, oxidative stress). Aim 3: Use the knowledge obtained to advocate for the adoption of WP-HWLs policies and disseminate information about WP harmful effects to young people in Florida and nationally. Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in Florida. This pioneering work will inform the FDA and public he

Primary Outcome

Intention and motivation to quit will be measured by using 3 items; "Does the participant intend to reduce WP smoking?"; "Does the participant intend to quit WP smoking?", and "How motivated is the participant to quit WP smoking in the next month?" The scale will be scored on a 5-point scale ranging from 1 (not at all), to 5 (very much).

Interventions

  • BEHAVIORAL Test Health Warning Label (HWL)
  • BEHAVIORAL Test without Health Warning Label (no-HWL)

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2022-10-03
Est. Completion 2024-12-09
Phase NA
Florida International University

89 total trials

What the finished NCT05317663 record still lists

NCT05317663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Test Health Warning Label (HWL) is the first listed.

NCT05317663 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05317663 about?

NCT05317663 is a clinical study titled "Developing and Testing Waterpipe-specific Health Warning Labels". Waterpipe (WP) smoking has become one of the leading tobacco use methods among youth in Florida. The impact of this dramatic rise is amplified by the mounting evidence of WP addictive and harmful nature, as well as the lag of policy response to it. Evidence suggests WP use leads to nicotine addictio...

What is the current status of trial NCT05317663?

This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2022-10-03. Estimated completion is 2024-12-09.

What interventions are being tested in trial NCT05317663?

The interventions under investigation include: Test Health Warning Label (HWL) (BEHAVIORAL), Test without Health Warning Label (no-HWL) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05317663?

This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05317663's enrollment target sits among peer trials

44 1423rd of 2000 higher than 566 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05317663, the US trial registry maintained by the National Library of Medicine. NCT05317663 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.