Effect of Different E-cigarette Cooling Flavors on Adults' Sensory Experience TCORS 3.0

Study Overview
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Brief Summary
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This pilot sensory experiment will examine cooling from comparable concentrations of WS-3 and menthol to determine appropriate concentrations to use in the main study.

Detailed Description
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This pilot study will establish low and high concentrations of both WS-3 and menthol concentrations to test in the main study. An anticipated 30 adult e-cigarette users will participate in one laboratory session during which participants will be exposed to e-liquids containing five different concentrations of two different cooling flavors without nicotine (10 e-liquids total). Participants will rate coolness using the generalized Labeled Magnitude Scale (gLMS). Using averages of participant ratings, we will select a low concentration of each constituent that is rated as more than barely detectable but less than moderate to ensure that cooling is weak but clearly perceptible. For the high concentration of each constituent, we will select a concentration that on average falls between strong and very strong to identify a strong cooling sensation while avoiding sensations that would also be uncomfortable.

Official Title
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Examine the Effects of Novel E-cigarette Constituents and Determining Appropriate Concentrations Among Adults

Conditions
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E-Cig Use

Intervention / Treatment
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* Other: E-liquid coolant (WS-3, 0.1%)
* Other: E-liquid coolant (WS-3, 0.25%)
* Other: E-liquid coolant (WS-3, 0.5%)
* Other: E-liquid coolant (WS-3, 1.0%)
* Other: E-liquid coolant (WS-3, 2.0%)
* Other: E-liquid coolant (menthol, 0.1%)
* Other: E-liquid coolant (menthol, 0.25%)
* Other: E-liquid coolant (menthol, 0.5%)
* Other: E-liquid coolant (menthol, 1.0%)
* Other: E-liquid coolant (menthol, 2.0%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Able to read and write Used e-cigarettes containing nicotine Use e-cigs in past 30 days Exclusion Criteria: Known hypersensitivity to propylene glycol Pregnant or lactating females Uncontrolled asthma Nut/e-liquid flavorant allergy Current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants are exposed to all study conditions (10 e-liquid samples).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WS-3 (1), no nicotine<br>WS-3 block: 0.1% | Other: E-liquid coolant (WS-3, 0.1%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%.<br>* Other names: Flavor type;|
| Experimental: WS-3 (2), no nicotine<br>WS-3 block: 0.25% | Other: E-liquid coolant (WS-3, 0.25%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.25%.<br>* Other names: Flavor type;|
| Experimental: WS-3 (3), no nicotine<br>WS-3 block: 0.5% | Other: E-liquid coolant (WS-3, 0.5%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%.<br>* Other names: Flavor type;|
| Experimental: WS-3 (4), no nicotine<br>WS-3 block: 1.0% | Other: E-liquid coolant (WS-3, 1.0%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%.<br>* Other names: Flavor type;|
| Experimental: WS-3 (5), no nicotine<br>WS-3 block: 2.0% | Other: E-liquid coolant (WS-3, 2.0%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%.<br>* Other names: Flavor type;|
| Experimental: Menthol (1), no nicotine<br>Menthol block: 0.1% | Other: E-liquid coolant (menthol, 0.1%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%.<br>* Other names: Flavor type;|
| Experimental: Menthol (2), no nicotine<br>Menthol block: 0.25% | Other: E-liquid coolant (menthol, 0.25%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.25%.<br>* Other names: Flavor type;|
| Experimental: Menthol (3), no nicotine<br>Menthol block: 0.5% | Other: E-liquid coolant (menthol, 0.5%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%.<br>* Other names: Flavor type;|
| Experimental: Menthol (4), no nicotine<br>Menthol block: 1.0% | Other: E-liquid coolant (menthol, 1.0%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%.<br>* Other names: Flavor type;|
| Experimental: Menthol (5), no nicotine<br>Menthol block: 2.0% | Other: E-liquid coolant (menthol, 2.0%)<br>* Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%.<br>* Other names: Flavor type;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coolness: Score change in coolness of each e-cigarette condition (10 conditions in total) | Difference in coolness at each e-cigarette condition as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: no sensation, barely detectable, weak, moderate, strong, very strong, and strongest imaginable, positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end). | Following administration of e-cigarette condition 1 (at 10 mins), then 5 mins post administration of each e-cigarette condition, up to 55 minutes (condition 10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cooling components, WS-3, menthol, e-cigarette, vaping