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Completed

NCT Number: NCT05932693

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

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.

Completed

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Key information

Conditions

E-Cig Use Behavior Smoking Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06473, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Able to read and write
  • Used e-cigarettes containing nicotine
  • Use e-cigs in past 30 days
  • No strong dislike of the menthol flavor
  • Urine cotinine ≥200ng/ml
  • Willing to abstain from tobacco/nicotine use 2 hrs prior to sessions

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
  • Dislike of menthol flavor

Treatment and study plan

E-liquid coolant (WS-3, 0.05%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.05%.

Other names: Flavor type

E-liquid coolant (WS-3, 0.1%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%.

Other names: Flavor type

E-liquid coolant (WS-3, 0.5%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%.

Other names: Flavor type

E-liquid coolant (WS-3, 1.0%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%.

Other names: Flavor type

E-liquid coolant (WS-3, 2.0%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%.

Other names: Flavor type

E-liquid coolant (menthol, 0.05%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.05%.

Other names: Flavor type

E-liquid coolant (menthol, 0.1%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%.

Other names: Flavor type

E-liquid coolant (menthol, 0.5%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%.

Other names: Flavor type

E-liquid coolant (menthol, 1.0%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%.

Other names: Flavor type

E-liquid coolant (menthol, 2.0%)

Other

Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%.

Other names: Flavor type

E-liquid coolant (WS-23, 0.05%)

Other

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.05%.

Other names: Flavor type

E-liquid coolant (WS-23, 0.1%)

Other

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.1%.

Other names: Flavor type

E-liquid coolant (WS-23, 0.5%)

Other

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.5%.

Other names: Flavor type

E-liquid coolant (WS-23, 1.0%)

Other

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 1.0%.

Other names: Flavor type

E-liquid coolant (WS-23, 2.0%)

Other

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 2.0%.

Other names: Flavor type

E-liquid coolant (WS-23, 4.0%)

Other

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 4.0%.

Other names: Flavor type

Primary outcomes

  1. Coolness: Score Change in Coolness of Each E-cigarette Condition (16 Conditions in Total)

    Time frame: 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)

    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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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