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

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Yale University

Status

Not yet enrolling

Conditions

E-Cig Use

Treatments

Other: E-liquid coolant (WS-23, 0.1%)
Other: E-liquid coolant (menthol, 0.1%)
Other: E-liquid coolant (WS-3, 0.05%)
Other: E-liquid coolant (menthol, 0.05%)
Other: E-liquid coolant (WS-23, 4.0%)
Other: E-liquid coolant (WS-3, 0.5%)
Other: E-liquid coolant (WS-3, 0.1%)
Other: E-liquid coolant (menthol, 0.5%)
Other: E-liquid coolant (WS-23, 0.05%)
Other: E-liquid coolant (menthol, 2.0%)
Other: E-liquid coolant (WS-3, 1.0%)
Other: E-liquid coolant (WS-23, 1.0%)
Other: E-liquid coolant (WS-23, 0.5%)
Other: E-liquid coolant (WS-3, 2.0%)
Other: E-liquid coolant (menthol, 1.0%)
Other: E-liquid coolant (WS-23, 2.0%)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05932693
2U54DA036151-11 (Other Grant/Funding Number)
2000035551_a

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 16 patient groups

WS-3 (1), no nicotine
Experimental group
Description:
WS-3 block: 0.05%
Treatment:
Other: E-liquid coolant (WS-3, 0.05%)
WS-3 (2), no nicotine
Experimental group
Description:
WS-3 block: 0.1%
Treatment:
Other: E-liquid coolant (WS-3, 0.1%)
WS-3 (3), no nicotine
Experimental group
Description:
WS-3 block: 0.5%
Treatment:
Other: E-liquid coolant (WS-3, 0.5%)
WS-3 (4), no nicotine
Experimental group
Description:
WS-3 block: 1.0%
Treatment:
Other: E-liquid coolant (WS-3, 1.0%)
WS-3 (5), no nicotine
Experimental group
Description:
WS-3 block: 2.0%
Treatment:
Other: E-liquid coolant (WS-3, 2.0%)
Menthol (1), no nicotine
Experimental group
Description:
Menthol block: 0.05%
Treatment:
Other: E-liquid coolant (menthol, 0.05%)
Menthol (2), no nicotine
Experimental group
Description:
Menthol block: 0.1%
Treatment:
Other: E-liquid coolant (menthol, 0.1%)
Menthol (3), no nicotine
Experimental group
Description:
Menthol block: 0.5%
Treatment:
Other: E-liquid coolant (menthol, 0.5%)
Menthol (4), no nicotine
Experimental group
Description:
Menthol block: 1.0%
Treatment:
Other: E-liquid coolant (menthol, 1.0%)
Menthol (5), no nicotine
Experimental group
Description:
Menthol block: 2.0%
Treatment:
Other: E-liquid coolant (menthol, 2.0%)
WS-23 (1), no nicotine
Experimental group
Description:
WS-23 block: 0.05%
Treatment:
Other: E-liquid coolant (WS-23, 0.05%)
WS-23 (2), no nicotine
Experimental group
Description:
WS-23 block: 0.1%
Treatment:
Other: E-liquid coolant (WS-23, 0.1%)
WS-23 (3), no nicotine
Experimental group
Description:
WS-23 block: 0.5%
Treatment:
Other: E-liquid coolant (WS-23, 0.5%)
WS-23 (4), no nicotine
Experimental group
Description:
WS-23 block: 1.0%
Treatment:
Other: E-liquid coolant (WS-23, 1.0%)
WS-23 (5), no nicotine
Experimental group
Description:
WS-23 block: 2.0%
Treatment:
Other: E-liquid coolant (WS-23, 2.0%)
WS-23 (6), no nicotine
Experimental group
Description:
WS-23 block: 4.0%
Treatment:
Other: E-liquid coolant (WS-23, 4.0%)

Trial contacts and locations

0

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Central trial contact

Danielle Davis, PhD; WEI Li, PhD

Data sourced from clinicaltrials.gov

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