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Health Warning Labels for Hookah Smoking
N/A
Recruiting
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.
Must not have
Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initially at the beginning of the smoking session (abstinence verification), and within 10 minutes after the wp smoking session
Awards & highlights
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 belowSelect...
I am between 21 and 35 years old.
Select...
I am between 21 and 35 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initially at the beginning of the smoking session (abstinence verification), and within 10 minutes after the wp smoking session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initially at the beginning of the smoking session (abstinence verification), and within 10 minutes after the wp smoking session
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 moreTrial 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.
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Who is running the clinical trial?
Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,307 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You use tobacco products more than five times per month within the last year.I started smoking water pipes recently or have been smoking them at least once a week.I have a history of heart issues, blood pressure problems, seizures, or I regularly use prescription meds.You have a long-term health condition or mental health condition that you have reported.I am not pregnant or breastfeeding.You are willing to attend the lab as required by the study protocol.I started smoking water pipes recently or have been smoking them at least once a week.I am between 21 and 35 years old.I am between 21 and 35 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Waterpipe with Health Warning Label (HWL)
- Group 2: Absence of Waterpipe without Health Warning Label (HWL)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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