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 |
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