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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036151-11 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WS-3 (1), no nicotine | Experimental | WS-3 block: 0.05% |
|
| WS-3 (2), no nicotine | Experimental | WS-3 block: 0.1% |
|
| WS-3 (3), no nicotine | Experimental | WS-3 block: 0.5% |
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| WS-3 (4), no nicotine | Experimental | WS-3 block: 1.0% |
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| WS-3 (5), no nicotine | Experimental | WS-3 block: 2.0% |
|
| Menthol (1), no nicotine | Experimental | Menthol block: 0.05% |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suchitra Krishnan-Sarin, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06473 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19833660 | Background | 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. | |
| 42406436 | Derived | Davis 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. |
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We may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
The identifiable information will be kept for 7 years. After that, the data will become anonymous.
The de-identified data will be made available for research purposes by contacting the PI.
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Prior to completion of the lab session, one participant did not attend (due to no-show) and was therefore excluded from the final dataset. A total of 30 participants completed the laboratory procedures and were assigned to the study conditions.
Participants were recruited from the local community and university settings using flyers, email advertisements, and online postings. Individuals who expressed interest were screened for eligibility and checked during intakes, and those meeting inclusion criteria were scheduled for a single laboratory session. A total of 31 eligible participants were enrolled, and 30 completed the study procedures, 27 were analyzed
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| ID | Title | Description |
|---|---|---|
| FG000 | A Single Lab Session With 16 Conditions/Exposures | Participants attended a lab session that included 16 conditions/exposures involving WS-3, WS-23, and menthol. The three types of coolants were presented in randomized blocks, with each block containing increasing concentrations. The specific 16 conditions are listed below: WS-3 block (1): 0.05%, no nicotine; WS-3 block (2): 0.1%, no nicotine; WS-3 block (3): 0.5%, no nicotine; WS-3 block (4): 1.0%, no nicotine; WS-3 block (5): 2.0%, no nicotine; Menthol block (1): 0.05%, no nicotine; Menthol block (2): 0.1%, no nicotine; Menthol block (3): 0.5%, no nicotine; Menthol block (4): 1.0%, no nicotine; Menthol block (5): 2.0%, no nicotine; WS-23 block (1): 0.05%, no nicotine; WS-23 block (2): 0.1%, no nicotine; WS-23 block (3): 0.5%, no nicotine; WS-23 block (4): 1.0%, no nicotine; WS-23 block (5): 2.0%, no nicotine; WS-23 block (6): 4.0%, no nicotine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2025 |
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Participants are exposed to all study conditions (16 e-liquid samples).
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Participants will be exposed to e-liquids containing 16 conditions (WS-3 block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%, WS-23 block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%, 4.0%, and menthol block: 0.05%, 0.1%, 0.5%, 1.0%, 2.0%) from low concentration to high concentration.
| Menthol (2), no nicotine | Experimental | Menthol block: 0.1% |
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| Menthol (3), no nicotine | Experimental | Menthol block: 0.5% |
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| Menthol (4), no nicotine | Experimental | Menthol block: 1.0% |
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| Menthol (5), no nicotine | Experimental | Menthol block: 2.0% |
|
| WS-23 (1), no nicotine | Experimental | WS-23 block: 0.05% |
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| WS-23 (2), no nicotine | Experimental | WS-23 block: 0.1% |
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| WS-23 (3), no nicotine | Experimental | WS-23 block: 0.5% |
|
| WS-23 (4), no nicotine | Experimental | WS-23 block: 1.0% |
|
| WS-23 (5), no nicotine | Experimental | WS-23 block: 2.0% |
|
| WS-23 (6), no nicotine | Experimental | WS-23 block: 4.0% |
|
| 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%. |
|
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| 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%. |
|
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| 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%. |
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| 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%. |
|
|
| E-liquid coolant (menthol, 0.05%) | Other | Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.05%. |
|
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| E-liquid coolant (menthol, 0.1%) | Other | Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.1%. |
|
|
| E-liquid coolant (menthol, 0.5%) | Other | Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 0.5%. |
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| E-liquid coolant (menthol, 1.0%) | Other | Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 1.0%. |
|
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| E-liquid coolant (menthol, 2.0%) | Other | Adult users of e-cigarette will be exposed to five e-liquid coolants menthol: 2.0%. |
|
|
| 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%. |
|
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| 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%. |
|
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| 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%. |
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| 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%. |
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| 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%. |
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| 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%. |
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| WS-3 Block (1): 0.05%, no Nicotine |
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| WS-3 Block (2): 0.1%, no Nicotine |
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| WS-3 Block (3): 0.5%, no Nicotine |
|
| WS-3 Block (4): 1.0%, no Nicotine |
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| WS-3 Block (5): 2.0%, no Nicotine |
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| Menthol Block (1): 0.05%, no Nicotine |
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| Menthol Block (2): 0.1%, no Nicotine |
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| Menthol Block (3): 0.5%, no Nicotine |
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| Menthol Block (4): 1.0%, no Nicotine |
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| Menthol Block (5): 2.0%, no Nicotine |
|
| WS-23 Block (1): 0.05%, no Nicotine |
|
| WS-23 Block (2): 0.1%, no Nicotine |
|
| WS-23 Block (3): 0.5%, no Nicotine |
|
| WS-23 Block (4): 1.0%, no Nicotine |
|
| WS-23 Block (5): 2.0%, no Nicotine |
|
| WS-23 Block (6): 4.0%, no Nicotine |
|
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics are presented for the 31 participants who were eligible to attend the lab session.
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| ID | Title | Description |
|---|---|---|
| BG000 | A Single Lab Session With 16 Conditions/Exposures | Participants attended a lab session that included 16 conditions/exposures involving WS-3, WS-23, and menthol. The three types of coolants were presented in randomized blocks, with each block containing increasing concentrations. The specific 16 conditions are listed below: WS-3 block (1): 0.05%, no nicotine; WS-3 block (2): 0.1%, no nicotine; WS-3 block (3): 0.5%, no nicotine; WS-3 block (4): 1.0%, no nicotine; WS-3 block (5): 2.0%, no nicotine; Menthol block (1): 0.05%, no nicotine; Menthol block (2): 0.1%, no nicotine; Menthol block (3): 0.5%, no nicotine; Menthol block (4): 1.0%, no nicotine; Menthol block (5): 2.0%, no nicotine; WS-23 block (1): 0.05%, no nicotine; WS-23 block (2): 0.1%, no nicotine; WS-23 block (3): 0.5%, no nicotine; WS-23 block (4): 1.0%, no nicotine; WS-23 block (5): 2.0%, no nicotine; WS-23 block (6): 4.0%, no nicotine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years old |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| E-cigarette use frequency | Mean number of days used in past 28 days | Mean | Standard Deviation | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | Scores on a scale | 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) |
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Participants complete an intake assessment and a single laboratory visit, with all assessments completed within approximately 2 weeks of enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WS-3 Block (1): 0.05% | WS-3 block (1): 0.05%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | WS-3 Block (2): 0.1% | WS-3 block (2): 0.1%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | WS-3 Block (3): 0.5% | WS-3 block (3): 0.5%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG003 | WS-3 Block (4): 1.0% | WS-3 block (4): 1.0%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG004 | WS-3 Block (5): 2.0% | WS-3 block (5): 2.0%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG005 | Menthol Block (1): 0.05% | Menthol block (1): 0.05%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG006 | Menthol Block (2): 0.1% | Menthol block (2): 0.1%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG007 | Menthol Block (3): 0.5% | Menthol block (3): 0.5%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG008 | Menthol Block (4): 1.0% | Menthol block (4): 1.0%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG009 | Menthol Block (5): 2.0% | Menthol block (5): 2.0%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG010 | WS-23 Block (1): 0.05% | WS-23 block (1): 0.05%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG011 | WS-23 Block (2): 0.1% | WS-23 block (2): 0.1%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG012 | WS-23 Block (3): 0.5% | WS-23 block (3): 0.5%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG013 | WS-23 Block (4): 1.0% | WS-23 block (4): 1.0%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG014 | WS-23 Block (5): 2.0% | WS-23 block (5): 2.0%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
| EG015 | WS-23 Block (6): 4.0% | WS-23 block (6): 4.0%, no nicotine | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suchitra Krishnan-Sarin and Danielle Davis | Yale University | 2039747607 | danielle.davis@yale.edu |
| Jan 5, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2024 | Jan 26, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008610 | Menthol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |
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| Non-Hispanic Asian |
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| Hispanic or Latino |
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| Others |
|