Developing and Testing Waterpipe-specific Health Warning Labels

Completed · Not applicable

Conditions studied: Waterpipe Smoking, Health Warning Label, Harm Perception, Puffing Behaviour, Quitting Smoking, Health Risk Behaviors

In brief

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 health advocates on the potential of WP-HWLs policies and provide a model for other states to respond to the WP epidemic.

Key facts

Study ID

NCT05317663

Run by

Florida International University

People needed

44

Starts

2022-10-03

Expected to finish

2024-12-09

Last updated by the study team

2024-12-10

Who can join

Age: 21 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age of 21-35 years.
• Beginners WP smokers (defined as started WP smoking in the past 6 months, but smoke WP less than weekly); or established WP smokers (defined as smoked at least once a week in the past 6 months).
• Generally healthy individuals (determined by physical examination).
• Is willing to provide informed consent.
• Is willing to attend the lab as required by the study protocol.
• Have abstained from WP for 12 hours prior to each lab session.

You may not qualify if…

• Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
• Individuals with self-reported history of chronic disease or psychiatric conditions.
• Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).
• Report tobacco product use regularly (> 5 times/month in the past year).

Where it is running

• Florida International University — Miami, Florida, United States

Full record on ClinicalTrials.gov

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