E-Cig UseNCT05932693
Effect of Different E-cigarette Cooling Flavors on Adults' Sensory Experience TCORS 3.0
A study testing E-liquid coolant (WS-3, 0.05%), E-liquid coolant (WS-3, 0.1%) and E-liquid coolant (WS-3, 0.5%) in people with E-Cig Use, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- E-Cig Use
- What is being tested?
- E-liquid coolant (WS-3, 0.05%), E-liquid coolant (WS-3, 0.1%) and E-liquid coolant (WS-3, 0.5%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06473
About this study
Official title: 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.
Read the 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.
- Conditions
- E-Cig Use
- Being tested
- E-liquid coolant (WS-3, 0.05%), E-liquid coolant (WS-3, 0.1%), E-liquid coolant (WS-3, 0.5%), E-liquid coolant (WS-3, 1.0%), E-liquid coolant (WS-3, 2.0%)
- Keywords
- Cooling components, e-cigarette, menthol, WS-23, WS-3
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-liquid coolant (WS-3, 0.05%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.05%.
E-liquid coolant (WS-3, 0.1%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%.
E-liquid coolant (WS-3, 0.5%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%.
E-liquid coolant (WS-3, 1.0%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%.
E-liquid coolant (WS-3, 2.0%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%.
E-liquid coolant (menthol, 0.05%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.05%.
E-liquid coolant (menthol, 0.1%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%.
E-liquid coolant (menthol, 0.5%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%.
E-liquid coolant (menthol, 1.0%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%.
E-liquid coolant (menthol, 2.0%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%.
E-liquid coolant (WS-23, 0.05%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.05%.
E-liquid coolant (WS-23, 0.1%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.1%.
E-liquid coolant (WS-23, 0.5%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.5%.
E-liquid coolant (WS-23, 1.0%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 1.0%.
E-liquid coolant (WS-23, 2.0%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 2.0%.
E-liquid coolant (WS-23, 4.0%)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 4.0%.
| Study group | Role | What they receive |
|---|---|---|
| WS-3 (1), no nicotine | Experimental | WS-3 block: 0.05% Receives: Other: E-liquid coolant (WS-3, 0.05%) |
| WS-3 (2), no nicotine | Experimental | WS-3 block: 0.1% Receives: Other: E-liquid coolant (WS-3, 0.1%) |
| WS-3 (3), no nicotine | Experimental | WS-3 block: 0.5% Receives: Other: E-liquid coolant (WS-3, 0.5%) |
| WS-3 (4), no nicotine | Experimental | WS-3 block: 1.0% Receives: Other: E-liquid coolant (WS-3, 1.0%) |
| WS-3 (5), no nicotine | Experimental | WS-3 block: 2.0% Receives: Other: E-liquid coolant (WS-3, 2.0%) |
| Menthol (1), no nicotine | Experimental | Menthol block: 0.05% Receives: Other: E-liquid coolant (menthol, 0.05%) |
| Menthol (2), no nicotine | Experimental | Menthol block: 0.1% Receives: Other: E-liquid coolant (menthol, 0.1%) |
| Menthol (3), no nicotine | Experimental | Menthol block: 0.5% Receives: Other: E-liquid coolant (menthol, 0.5%) |
| Menthol (4), no nicotine | Experimental | Menthol block: 1.0% Receives: Other: E-liquid coolant (menthol, 1.0%) |
| Menthol (5), no nicotine | Experimental | Menthol block: 2.0% Receives: Other: E-liquid coolant (menthol, 2.0%) |
| WS-23 (1), no nicotine | Experimental | WS-23 block: 0.05% Receives: Other: E-liquid coolant (WS-23, 0.05%) |
| WS-23 (2), no nicotine | Experimental | WS-23 block: 0.1% Receives: Other: E-liquid coolant (WS-23, 0.1%) |
| WS-23 (3), no nicotine | Experimental | WS-23 block: 0.5% Receives: Other: E-liquid coolant (WS-23, 0.5%) |
| WS-23 (4), no nicotine | Experimental | WS-23 block: 1.0% Receives: Other: E-liquid coolant (WS-23, 1.0%) |
| WS-23 (5), no nicotine | Experimental | WS-23 block: 2.0% Receives: Other: E-liquid coolant (WS-23, 2.0%) |
| WS-23 (6), no nicotine | Experimental | WS-23 block: 4.0% Receives: Other: E-liquid coolant (WS-23, 4.0%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start3 Sep 2024
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for E-Cig UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are exposed to all study conditions (16 e-liquid samples).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Suchitra Krishnan-Sarin, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932693
- Sponsor's protocol ID
- 2000035551_a
- Other IDs
- 2U54DA036151-11
- Status last verified
- Feb 2026
- First submitted
- 28 Jun 2023
- Last updated
- 18 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
Publications
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.
PubMed 19833660Davis DR, Li W, Wu R, Gueorguieva R, Mellinghoff RA, Zimmerman JB, Erythropel HC, Krishnan-Sarin S. Comparing the sensory effects of menthol and synthetic coolants in e-liquids: A pilot investigation. Exp Clin Psychopharmacol. 2026 Jul 6. doi: 10.1037/pha0000865. Online ahead of print.
PubMed 42406436
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examine the Effects of Novel E-cigarette Constituents and Determining Appropriate Concentrations Among Adults
- ClinicalTrials.gov ID
- NCT05932693
- Acronym / sponsor ID
- 2000035551_a
- Conditions
- E-Cig Use
- Keywords
- Cooling components, e-cigarette, menthol, WS-23, WS-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
- Model description
- Participants are exposed to all study conditions (16 e-liquid samples).
| Arm | Type | Receives |
|---|---|---|
| WS-3 (1), no nicotine | Experimental | Other: E-liquid coolant (WS-3, 0.05%)WS-3 block: 0.05% |
| WS-3 (2), no nicotine | Experimental | Other: E-liquid coolant (WS-3, 0.1%)WS-3 block: 0.1% |
| WS-3 (3), no nicotine | Experimental | Other: E-liquid coolant (WS-3, 0.5%)WS-3 block: 0.5% |
| WS-3 (4), no nicotine | Experimental | Other: E-liquid coolant (WS-3, 1.0%)WS-3 block: 1.0% |
| WS-3 (5), no nicotine | Experimental | Other: E-liquid coolant (WS-3, 2.0%)WS-3 block: 2.0% |
| Menthol (1), no nicotine | Experimental | Other: E-liquid coolant (menthol, 0.05%)Menthol block: 0.05% |
| Menthol (2), no nicotine | Experimental | Other: E-liquid coolant (menthol, 0.1%)Menthol block: 0.1% |
| Menthol (3), no nicotine | Experimental | Other: E-liquid coolant (menthol, 0.5%)Menthol block: 0.5% |
| Menthol (4), no nicotine | Experimental | Other: E-liquid coolant (menthol, 1.0%)Menthol block: 1.0% |
| Menthol (5), no nicotine | Experimental | Other: E-liquid coolant (menthol, 2.0%)Menthol block: 2.0% |
| WS-23 (1), no nicotine | Experimental | Other: E-liquid coolant (WS-23, 0.05%)WS-23 block: 0.05% |
| WS-23 (2), no nicotine | Experimental | Other: E-liquid coolant (WS-23, 0.1%)WS-23 block: 0.1% |
| WS-23 (3), no nicotine | Experimental | Other: E-liquid coolant (WS-23, 0.5%)WS-23 block: 0.5% |
| WS-23 (4), no nicotine | Experimental | Other: E-liquid coolant (WS-23, 1.0%)WS-23 block: 1.0% |
| WS-23 (5), no nicotine | Experimental | Other: E-liquid coolant (WS-23, 2.0%)WS-23 block: 2.0% |
| WS-23 (6), no nicotine | Experimental | Other: E-liquid coolant (WS-23, 4.0%)WS-23 block: 4.0% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-liquid coolant (WS-3, 0.05%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.05%. | Other | WS-3 (1), no nicotine |
| E-liquid coolant (WS-3, 0.1%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%. | Other | WS-3 (2), no nicotine |
| E-liquid coolant (WS-3, 0.5%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%. | Other | WS-3 (3), no nicotine |
| E-liquid coolant (WS-3, 1.0%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%. | Other | WS-3 (4), no nicotine |
| E-liquid coolant (WS-3, 2.0%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%. | Other | WS-3 (5), no nicotine |
| E-liquid coolant (menthol, 0.05%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.05%. | Other | Menthol (1), no nicotine |
| E-liquid coolant (menthol, 0.1%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%. | Other | Menthol (2), no nicotine |
| E-liquid coolant (menthol, 0.5%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%. | Other | Menthol (3), no nicotine |
| E-liquid coolant (menthol, 1.0%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%. | Other | Menthol (4), no nicotine |
| E-liquid coolant (menthol, 2.0%)Also: Flavor typeAdult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%. | Other | Menthol (5), no nicotine |
| E-liquid coolant (WS-23, 0.05%)Also: Flavor typeAdult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.05%. | Other | WS-23 (1), no nicotine |
| E-liquid coolant (WS-23, 0.1%)Also: Flavor typeAdult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.1%. | Other | WS-23 (2), no nicotine |
| E-liquid coolant (WS-23, 0.5%)Also: Flavor typeAdult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.5%. | Other | WS-23 (3), no nicotine |
| E-liquid coolant (WS-23, 1.0%)Also: Flavor typeAdult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 1.0%. | Other | WS-23 (4), no nicotine |
| E-liquid coolant (WS-23, 2.0%)Also: Flavor typeAdult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 2.0%. | Other | WS-23 (5), no nicotine |
| E-liquid coolant (WS-23, 4.0%)Also: Flavor typeAdult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 4.0%. | Other | WS-23 (6), no nicotine |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19833660Lim 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.
- Derived from this study: PubMed 42406436Davis DR, Li W, Wu R, Gueorguieva R, Mellinghoff RA, Zimmerman JB, Erythropel HC, Krishnan-Sarin S. Comparing the sensory effects of menthol and synthetic coolants in e-liquids: A pilot investigation. Exp Clin Psychopharmacol. 2026 Jul 6. doi: 10.1037/pha0000865. Online ahead of print.
- Individual participant dataSharing planned: Yes. We may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suchitra Krishnan-Sarin, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-liquid coolant (WS-3, 0.05%), E-liquid coolant (WS-3, 0.1%) and E-liquid coolant (WS-3, 0.5%) in people with E-Cig Use, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.