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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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