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

February 4, 2026 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06473
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Flavor type
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:
  • Flavor type
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:
  • Flavor type
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:
  • Flavor type
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:
  • Flavor type
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:
  • Flavor type
Experimental: WS-3 (1), no nicotine
WS-3 block: 0.05%
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%.
Other Names:
  • Flavor type
Experimental: WS-3 (2), 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:
  • Flavor type
Experimental: Menthol (1), no nicotine
Menthol block: 0.05%
Other: E-liquid coolant (menthol, 0.05%)
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.05%.
Other Names:
  • Flavor type
Experimental: Menthol (2), 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:
  • Flavor type
Experimental: WS-23 (1), no nicotine
WS-23 block: 0.05%
Other: E-liquid coolant (WS-23, 0.05%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.05%.
Other Names:
  • Flavor type
Experimental: WS-23 (2), no nicotine
WS-23 block: 0.1%
Other: E-liquid coolant (WS-23, 0.1%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.1%.
Other Names:
  • Flavor type
Experimental: WS-23 (3), no nicotine
WS-23 block: 0.5%
Other: E-liquid coolant (WS-23, 0.5%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.5%.
Other Names:
  • Flavor type
Experimental: WS-23 (4), no nicotine
WS-23 block: 1.0%
Other: E-liquid coolant (WS-23, 1.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 1.0%.
Other Names:
  • Flavor type
Experimental: WS-23 (5), no nicotine
WS-23 block: 2.0%
Other: E-liquid coolant (WS-23, 2.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 2.0%.
Other Names:
  • Flavor type
Experimental: WS-23 (6), no nicotine
WS-23 block: 4.0%
Other: E-liquid coolant (WS-23, 4.0%)
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 4.0%.
Other Names:
  • Flavor type

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Suchitra Krishnan-Sarin, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Actual)

January 9, 2025

Study Completion (Actual)

January 9, 2025

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000035551_a
  • 2U54DA036151-11 (U.S. NIH Grant/Contract: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.

IPD Sharing Time Frame

The identifiable information will be kept for 7 years. After that, the data will become anonymous.

IPD Sharing Access Criteria

The de-identified data will be made available for research purposes by contacting the PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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