Developing and Testing Waterpipe-specific Health Warning Labels

Health Risk Behaviors Clinical Trial

Official title:

Developing and Testing Waterpipe-specific Health Warning Labels Targeting Young People in Florida

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317663
• Other study ID #: 20B16
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: May 2025

Study information

• Verified date: November 2023
• Source: Florida International University
• Contact: Wasim Maziak, PhD, MD
• Phone: 3053484501
• Email: wmaziak[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

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

Description:

Our Team developed 12 pictorial Health Warning Labels (HWLs) for the waterpipe (WP) corresponding to 4 themes; health risks/addiction, harm to others, specific harm, and harm compared to cigarettes. The investigators will build on this work to advance HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally through the following specific aims:

1. Adapt the HWLs to young adults in Florida using focus groups. The investigators will conduct mixed- gender focus groups combined with brief survey with regular WP smokers (6-8 groups; n ≈ 65; age 18-29 yrs) to 1- adapt the 12 HWLs to our target population, 2- explore their optimal placement and size, and 3- select the top 4 HWLs for testing (Aim 2).

2. Test the top 4 HWLs in a clinical lab experiment. Using the top 4 HWLs on the device, the investigators will recruit 2 groups of WP smokers (n= 248; age 18-29 yrs) based on their use frequency (beginners, established) for a within- (HWL vs no-HWL; pre- vs post- smoking) and between-subject (beginner vs. established; 4 HWLs) experiment. Participants will be randomly assigned to one of the 4 HWLs conditions and undergo 2 smoking sessions that differ by HWL (HWL vs. no-HWL), with pre-post smoking assessment of harm perception, intention to quit, and toxicant exposure. Participants will receive a follow-up phone call 3- month after exposure to assess longer-term changes in quit attitude and behavior. The investigators hypothesize that applying pictorial HWLs to the WP device will; 1- significantly increase harm perception and intention to quit, and reduce puffing behavior, satisfaction, and exposure to toxicants compared to no-HWL; 2- this effect will be more pronounced in beginner than established smokers.

3. Disseminate knowledge. The investigators will partner with Tobacco-Free Workgroup, and Truth Initiative to advocate for the adoption of HWLs policies and disseminate knowledge about WP harmful effects to young people in Florida and nationally.

Impact: Communicating WP risks through HWLs promises to reduce WP use and WP-related morbidly and mortality among young adults in the US.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: May 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Health Risk Behaviors
• Quitting Smoking
• Waterpipe Smoking

Intervention

Behavioral:
• Test Health Warning Label (HWL)
Effect of Health Warning Label (HWL)
• Test without Health Warning Label (no-HWL)
Effect of no Health Warning Label (no-HWL)

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention and motivation to quit	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).	pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.
Secondary	Harm perception	Harm perception will be measured by using 1 item "To what extent does the participant think about the serious health effects of WP smoking?". This scale will assess WP harm perception and measure perceptions of WP relative risk compared to cigarettes. The scale will be scored on a 7-point scale ranging from 1 (not at all harmful), to 7 (extremely harmful).	pre-/post-smoking and at 3-month assessment. Each session is approximately 45 minutes ad lib use period.
Secondary	Exhaled Breath Condensate (EBC)	To test for markers of oxidative stress and DNA damage. The investigators will test for 6 biomarkers (8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxoguanosine, 8-isoprostane, formaldehyde, acetaldehyde and malondialdehyde). Samples will be collected during 15 min of tidal breathing through a single-use disposable Respiratory Tube Tympanic Membrane collector (Respiratory Research, Inc., Charlottesville, Va., USA). After sample collection, a plunger will be used to pool the condensed material within the tube into a single sample (about 1.0-2 ml). EBC samples will be divided in aliquots and stored at -80°C. EBC samples will be analyzed by our Forensic Chemistry Lab at Florida International University using Online Solid-Phase Extraction and Liquid Chromatography Triple Quadrupole Mass Spectrometry and Gas Chromatography Mass Spectrometry.	It will be collected pre-post smoking session. Each session is approximately 45 minutes ad lib use period.
Secondary	Social interaction	Social interaction will be measured by using 1 item "Since the participant started the study, how many times did the participant have a conversations with the family/friends about the HWLs?"	at 3-month assessment
Secondary	Change in WP smoking	Change in WP smoking will be measured by using 3 items; "Since the participant started the study, 1- did the participant stop smoking for 1 day or longer because the participant was trying to quit WP smoking?, 2- did the participant avoid smoking WP because the participant was thinking about the HWLs?, and 3- did the participant stop WP smoking completely because of the HWLs?"	at 3-month assessment
Secondary	Toxicant exposure: expired carbon monoxide	expired carbon monoxide will be measured via expired carbon monoxide monitor.	initially at the beginning of the smoking session (abstinence verification), and within 10 minutes after the WP smoking session
Secondary	Puff topography	Measurement of puffing behavior.	continuously during smoking. Puffing behavior is continuously measured during each WP smoking session (an approximately 45 minutes ad lib use period)
Secondary	Hear rate	Change in heart rate, measured in beats per minute.	continuously during smoking. Each session is approximately 45 minutes ad lib use period.
Secondary	Blood pressure	Change in blood pressure, measured in mm/hg.	continuously during smoking. Each session is approximately 45 minutes ad lib use period.
Secondary	Duke Sensory Questionnaire (DSQ)	This scale will assess participants sensory experience of the inhaled product. The scale has nine items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).	DSQ will be measured only after smoking. The session is approximately 45 minutes ad lib use period.
Secondary	The Cigarette/WP Evaluation Scale (WES)	This scale assesses participants' perception of WP smoking. The scale has 11 items. All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).	WES will be measured only after smoking. The session is approximately 45 minutes ad lib use period.
Secondary	Minnesota Nicotine Withdrawal Scale	This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0 - 100. These items are presented as Visual Analog Scale with item (measure) centered above a horizontal line anchored on the left with not at all and on the right with extremely.	During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period.
Secondary	Questionnaire of Smoking Urges	This scale is used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 10 items that are scored 0 - 7. Rated on a 7-point Likert scale ranging from 0 (strongly disagree) to 6 (strongly agree).	During participants' 1st and 2nd visit. Questionnaire will be administered 2 times in each smoking session: before and after an approximately 45-min ad lib use period
Secondary	Lung function tests (LFTs)	LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after hookah smoking. According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., % predicted value pred (FVC), FEV1 % pred FEV1/FVC, % pred); forced expiratory flow (FEF) and peak expiratory flow rate or (PEFR) will be performed. Diffusing capacity for carbon monoxide (DLCO) will be determined using a rapidly resolving gas analyzer (RGA) and the single-breath technique. Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.	During participants' 2 study visits. Lung function tests will be measured 2 times in each hookah smoking session: before and after an approximately 45 minutes ad lib use period