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

E-Cig Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05932693
• Other study ID #: 2000035551_a
• Secondary ID: 2U54DA036151-11
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: Danielle Davis, PhD
• Phone: 203-974-7607
• Email: danielle.davis[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• E-Cig Use

Intervention

Other:
• E-liquid coolant (WS-3, 0.05%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.05%.
• E-liquid coolant (WS-3, 0.1%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%.
• E-liquid coolant (WS-3, 0.5%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%.
• E-liquid coolant (WS-3, 1.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%.
• E-liquid coolant (WS-3, 2.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%.
• E-liquid coolant (menthol, 0.05%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.05%.
• E-liquid coolant (menthol, 0.1%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%.
• E-liquid coolant (menthol, 0.5%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%.
• E-liquid coolant (menthol, 1.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%.
• E-liquid coolant (menthol, 2.0%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%.
• E-liquid coolant (WS-23, 0.05%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.05%.
• E-liquid coolant (WS-23, 0.1%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.1%.
• E-liquid coolant (WS-23, 0.5%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.5%.
• E-liquid coolant (WS-23, 1.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 1.0%.
• E-liquid coolant (WS-23, 2.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 2.0%.
• E-liquid coolant (WS-23, 4.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 4.0%.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

References & Publications (1)

Lim J, Wood A, Green BG. Derivation and evaluation of a labeled hedonic scale. Chem Senses. 2009 Nov;34(9):739-51. doi: 10.1093/chemse/bjp054. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coolness: Score change in coolness of each e-cigarette condition (16 conditions in total)	Difference in overall flavor intensity, coolness, sweetness and harshness/irritation 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 minutes), then 5 minutes post administration of each e-cigarette condition, up to 85 minutes (condition 16)