Effect of Different E-cigarette Cooling Flavors on Adults' Sensory Experience TCORS 3.0
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: WS-3 (1), no nicotine WS-3 block: 0.1% |
Other: E-liquid coolant (WS-3, 0.1%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%.
Other Names:
|
| Experimental: WS-3 (2), no nicotine WS-3 block: 0.25% |
Other: E-liquid coolant (WS-3, 0.25%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.25%.
Other Names:
|
| Experimental: WS-3 (3), no nicotine WS-3 block: 0.5% |
Other: E-liquid coolant (WS-3, 0.5%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%.
Other Names:
|
| Experimental: WS-3 (4), no nicotine WS-3 block: 1.0% |
Other: E-liquid coolant (WS-3, 1.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%.
Other Names:
|
| Experimental: WS-3 (5), no nicotine WS-3 block: 2.0% |
Other: E-liquid coolant (WS-3, 2.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%.
Other Names:
|
| Experimental: Menthol (1), no nicotine Menthol block: 0.1% |
Other: E-liquid coolant (menthol, 0.1%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%.
Other Names:
|
| Experimental: Menthol (2), no nicotine Menthol block: 0.25% |
Other: E-liquid coolant (menthol, 0.25%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.25%.
Other Names:
|
| Experimental: Menthol (3), no nicotine Menthol block: 0.5% |
Other: E-liquid coolant (menthol, 0.5%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%.
Other Names:
|
| Experimental: Menthol (4), no nicotine Menthol block: 1.0% |
Other: E-liquid coolant (menthol, 1.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%.
Other Names:
|
| Experimental: Menthol (5), no nicotine Menthol block: 2.0% |
Other: E-liquid coolant (menthol, 2.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Coolness: Score change in coolness of each e-cigarette condition (10 conditions in total) [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)]
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).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Yale University
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Suchitra Krishnan-Sarin, PhD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
- 2000035551_a
- 2U54DA036151-11