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Health Warning Labels for Hookah Smoking

Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of 21-35 years.
Age of 21-35 years.
Screening 3 weeks
Treatment Varies
Follow Up at 3-month assessment
Awards & highlights

Study Summary

This trial will adapt 12 waterpipe health warning labels (HWLs) for young adults in Florida, test their performance in a clinical lab experiment, and advocate for the adoption of WP-HWL policies.

Who is the study for?
This trial is for young adults aged 21-35 in Florida who are either new to waterpipe (WP) smoking or smoke at least once a week. Participants must be generally healthy, not pregnant, breastfeeding, or have chronic diseases. They should abstain from WP for 12 hours before lab sessions and agree to attend all study visits.Check my eligibility
What is being tested?
The study tests the effectiveness of health warning labels (HWLs) on waterpipes compared to no label. It aims to see if HWLs change smokers' views on harm and intentions to quit by measuring their responses and exposure levels to toxins like carbon monoxide and nicotine.See study design
What are the potential side effects?
Since this trial involves behavioral interventions with health warning labels rather than medical treatments, there are no direct side effects associated with the interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am between 21 and 35 years old.
I am between 21 and 35 years old.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3-month assessment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3-month assessment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intention and motivation to quit
Secondary outcome measures
Blood pressure
Change in WP smoking
Duke Sensory Questionnaire (DSQ)
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Waterpipe with Health Warning Label (HWL)Experimental Treatment1 Intervention
All participants will complete a lab visit where they will smoke waterpipe with HWL for up to 45 minutes.
Group II: Absence of Waterpipe without Health Warning Label (HWL)Experimental Treatment1 Intervention
All participants will complete a lab visit where they will smoke waterpipe without HWL for up to 45 minutes.

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,307 Total Patients Enrolled

Media Library

Test Health Warning Label (HWL) Clinical Trial Eligibility Overview. Trial Name: NCT05317663 — N/A
Hookah Smoking Research Study Groups: Waterpipe with Health Warning Label (HWL), Absence of Waterpipe without Health Warning Label (HWL)
Test Health Warning Label (HWL) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317663 — N/A
Hookah Smoking Clinical Trial 2023: Test Health Warning Label (HWL) Highlights & Side Effects. Trial Name: NCT05317663 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Test Health Warning Label (HWL) been given regulatory clearance by the FDA?

"There is ample scientific evidence that Test HWL is a safe and efficacious treatment, thus it received the highest rating of 3 on our scale."

Answered by AI

Is the enrollment process for this experiment open currently?

"As per clinicaltrials.gov, this investigation is recruiting patients at the moment. The initial listing was published on October 3rd 2022 and it has been updated most recently on the same date."

Answered by AI

Does this clinical experiment accommodate those aged 80 and over?

"This study seeks to include individuals between the ages of 21 and 35."

Answered by AI

What are the prime purposes of this experiment?

"This trial's primary outcome measure is plasma nicotine levels, pre- and post-smoking at a 3 month assessment. The Minnesota Nicotine Withdrawal Scale measured over 45 minutes of ad lib use period will be used as the secondary indicator; this questionnaire consists of 11 items scored 0 to 100 presented on a Visual Analog Scale. To evaluate oxidative stress and DNA damage, Exhaled Breath Condensate (EBC) analysis - collecting samples via Respiratory Tube Tympanic Membrane collector during 15 mins of tidal breathing - also serves as an additional metric for evaluation. Lung Function Tests such as spirometry % predicted value (FVC"

Answered by AI

What is the current enrollment size for this research project?

"Accurate. Clinicaltrials.gov documents that this medical study, which was first published on the 3rd of October 2022, is still recruiting volunteers. The trial requires 248 participants from a single medical centre to complete it."

Answered by AI

Who is able to sign up for participation in this experiment?

"This scientific study is actively looking to enrol 248 individuals aged 21-35 who engage in risk behaviour and have a baseline level of health. Additionally, prospective participants must be either recent initiators or regular consumers of the studied product (defined as within 6 months), pass a physical examination, provide informed consent, agree to visit lab sessions as mandated by protocol, and abstain from the said substance for 12 hours prior to each laboratory appointment."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
Florida International University
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I want to quit.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Florida International University: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
~99 spots leftby Apr 2025