NCT05932693

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 3, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 22, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

June 28, 2023

Results QC Date

December 5, 2025

Last Update Submit

February 4, 2026

Conditions

E-Cig Use

Keywords

Cooling componentse-cigarettementholWS-23WS-3

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (16)

WS-3 (1), no nicotine

EXPERIMENTAL

WS-3 block: 0.05%

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

WS-3 (2), no nicotine

EXPERIMENTAL

WS-3 block: 0.1%

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

WS-3 (3), no nicotine

EXPERIMENTAL

WS-3 block: 0.5%

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

WS-3 (4), no nicotine

EXPERIMENTAL

WS-3 block: 1.0%

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

WS-3 (5), no nicotine

EXPERIMENTAL

WS-3 block: 2.0%

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

Menthol (1), no nicotine

EXPERIMENTAL

Menthol block: 0.05%

Other: E-liquid coolant (menthol, 0.05%)

Menthol (2), no nicotine

EXPERIMENTAL

Menthol block: 0.1%

Other: E-liquid coolant (menthol, 0.1%)

Menthol (3), no nicotine

EXPERIMENTAL

Menthol block: 0.5%

Other: E-liquid coolant (menthol, 0.5%)

Menthol (4), no nicotine

EXPERIMENTAL

Menthol block: 1.0%

Other: E-liquid coolant (menthol, 1.0%)

Menthol (5), no nicotine

EXPERIMENTAL

Menthol block: 2.0%

Other: E-liquid coolant (menthol, 2.0%)

WS-23 (1), no nicotine

EXPERIMENTAL

WS-23 block: 0.05%

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

WS-23 (2), no nicotine

EXPERIMENTAL

WS-23 block: 0.1%

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

WS-23 (3), no nicotine

EXPERIMENTAL

WS-23 block: 0.5%

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

WS-23 (4), no nicotine

EXPERIMENTAL

WS-23 block: 1.0%

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

WS-23 (5), no nicotine

EXPERIMENTAL

WS-23 block: 2.0%

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

WS-23 (6), no nicotine

EXPERIMENTAL

WS-23 block: 4.0%

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

Interventions

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%.

Also known as: Flavor type
WS-3 (1), no nicotine
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%.

Also known as: Flavor type
WS-3 (2), no nicotine
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%.

Also known as: Flavor type
WS-3 (3), no nicotine
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%.

Also known as: Flavor type
WS-3 (4), no nicotine
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%.

Also known as: Flavor type
WS-3 (5), no nicotine
E-liquid coolant (menthol, 0.05%)OTHER

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

Also known as: Flavor type
Menthol (1), no nicotine
E-liquid coolant (menthol, 0.1%)OTHER

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

Also known as: Flavor type
Menthol (2), no nicotine
E-liquid coolant (menthol, 0.5%)OTHER

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

Also known as: Flavor type
Menthol (3), no nicotine
E-liquid coolant (menthol, 1.0%)OTHER

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

Also known as: Flavor type
Menthol (4), no nicotine
E-liquid coolant (menthol, 2.0%)OTHER

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

Also known as: Flavor type
Menthol (5), no nicotine
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%.

Also known as: Flavor type
WS-23 (1), no nicotine
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%.

Also known as: Flavor type
WS-23 (2), no nicotine
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%.

Also known as: Flavor type
WS-23 (3), no nicotine
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%.

Also known as: Flavor type
WS-23 (4), no nicotine
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%.

Also known as: Flavor type
WS-23 (5), no nicotine
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%.

Also known as: Flavor type
WS-23 (6), no nicotine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06473, United States

Location

Related Publications (1)

  • 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.

    PMID: 19833660BACKGROUND

MeSH Terms

Conditions

Vaping

Interventions

Menthol

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipids

Results Point of Contact

Title
Suchitra Krishnan-Sarin and Danielle Davis
Organization
Yale University
danielle.davis@yale.edu
2039747607

Study Officials

  • Suchitra Krishnan-Sarin, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants are exposed to all study conditions (16 e-liquid samples).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 6, 2023

Study Start

September 3, 2024

Primary Completion

January 9, 2025

Study Completion

January 9, 2025

Last Updated

February 18, 2026

Results First Posted

January 22, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
The identifiable information will be kept for 7 years. After that, the data will become anonymous.
Access Criteria
The de-identified data will be made available for research purposes by contacting the PI.

Locations

US(1)