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.
- Hookah Smoking
- Harm Perception
- Pica
- Quitting Smoking
- Risky Health Behaviors
- Health Warning Label
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 13 Secondary · Reporting Duration: at 3-month assessment
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Waterpipe with Health Warning Label (HWL)
1 of 2
Absence of Waterpipe without Health Warning Label (HWL)
1 of 2
Experimental Treatment
248 Total Participants · 2 Treatment Groups
Primary Treatment: Test Health Warning Label (HWL) · No Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 21 - 35 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Florida | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Florida International University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Most responsive sites:
- Florida International University: < 48 hours
Typically responds via
| Phone Call | 100.0% |
Average response time
- < 2 Days
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
Does this clinical experiment accommodate those aged 80 and over?
"This study seeks to include individuals between the ages of 21 and 35." - Anonymous Online Contributor
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor