MedDataX Logo

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

NCT ID: NCT05932693

Last Updated: 2026-01-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2025-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

NCT05932745

Nicotine Use Disorder
RECRUITING NA

Effects of Flavors on Nicotine Reinforcement in Smokers

NCT03243630

Nicotine Dependence
COMPLETED EARLY_PHASE1

Impact of Flavors on Nicotine Perception and Self-Administration Via E-cigarettes

NCT04038515

Nicotine E-liquid Flavors
COMPLETED PHASE2

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

NCT02102100

Nicotine Dependence
COMPLETED NA

Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol

NCT03580525

Nicotine Dependence
COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

E-Cig Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants are exposed to all study conditions (16 e-liquid samples).
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WS-3 (1), no nicotine

WS-3 block: 0.05%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.05%.

WS-3 (2), no nicotine

WS-3 block: 0.1%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.1%.

WS-3 (3), no nicotine

WS-3 block: 0.5%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.5%.

WS-3 (4), no nicotine

WS-3 block: 1.0%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 1.0%.

WS-3 (5), no nicotine

WS-3 block: 2.0%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 2.0%.

Menthol (1), no nicotine

Menthol block: 0.05%

Group Type EXPERIMENTAL

E-liquid coolant (menthol, 0.05%)

Intervention Type OTHER

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

Menthol (2), no nicotine

Menthol block: 0.1%

Group Type EXPERIMENTAL

E-liquid coolant (menthol, 0.1%)

Intervention Type OTHER

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

Menthol (3), no nicotine

Menthol block: 0.5%

Group Type EXPERIMENTAL

E-liquid coolant (menthol, 0.5%)

Intervention Type OTHER

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

Menthol (4), no nicotine

Menthol block: 1.0%

Group Type EXPERIMENTAL

E-liquid coolant (menthol, 1.0%)

Intervention Type OTHER

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

Menthol (5), no nicotine

Menthol block: 2.0%

Group Type EXPERIMENTAL

E-liquid coolant (menthol, 2.0%)

Intervention Type OTHER

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

WS-23 (1), no nicotine

WS-23 block: 0.05%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.05%.

WS-23 (2), no nicotine

WS-23 block: 0.1%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.1%.

WS-23 (3), no nicotine

WS-23 block: 0.5%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 0.5%.

WS-23 (4), no nicotine

WS-23 block: 1.0%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 1.0%.

WS-23 (5), no nicotine

WS-23 block: 2.0%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 2.0%.

WS-23 (6), no nicotine

WS-23 block: 4.0%

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Adult users of e-cigarette will be exposed to six e-liquid coolants WS-23: 4.0%.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Adult users of e-cigarette will be exposed to five e-liquid coolants WS-3: 0.05%.

Intervention Type 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%.

Intervention Type 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%.

Intervention Type 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%.

Intervention Type 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%.

Intervention Type OTHER

E-liquid coolant (menthol, 0.05%)

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

Intervention Type OTHER

E-liquid coolant (menthol, 0.1%)

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

Intervention Type OTHER

E-liquid coolant (menthol, 0.5%)

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

Intervention Type OTHER

E-liquid coolant (menthol, 1.0%)

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

Intervention Type OTHER

E-liquid coolant (menthol, 2.0%)

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

Intervention Type 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%.

Intervention Type 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%.

Intervention Type 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%.

Intervention Type 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%.

Intervention Type 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%.

Intervention Type 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%.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type Flavor type

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suchitra Krishnan-Sarin, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19833660 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2U54DA036151-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000035551_a

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
NCT03164668 COMPLETED NA
Effects of E-Cigarette Flavors on Adults TCORS 2.0
NCT03635333 COMPLETED PHASE1
Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
NCT03905928 COMPLETED NA
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
NCT03402243 COMPLETED NA
Effects of Menthol in E-cigarettes on Smoking Behaviors
NCT04521647 COMPLETED PHASE1
Do Flavors Increase the Addiction Potential of Nicotine?
NCT04696380 COMPLETED PHASE2
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
NCT02179034 COMPLETED PHASE1
Use Behavior, Nicotine Uptake, and Subjective Effects Comparison of Tobacco and Menthol e-Liquids by ENDS Consumers
NCT05134415 COMPLETED NA
Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use
NCT02870218 COMPLETED PHASE2
Nicotine's Potential Abuse With Menthol
NCT04535362 COMPLETED EARLY_PHASE1
Manipulating Tobacco Constituents in Female Menthol Smokers
NCT02048852 COMPLETED NA
Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 2
NCT03168191 COMPLETED PHASE1
E-cigarettes, Nicotine Inhaler, and Blood Vessel Function
NCT03072628 COMPLETED NA
Effects of E-Cigarettes in Menthol Smokers
NCT05949034 COMPLETED NA
Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
NCT01522963 COMPLETED NA
Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users
NCT03710590 COMPLETED NA
Menthol and Mint Experimental Tobacco Marketplace (ETM) Study
NCT04879225 COMPLETED NA
Nicotine Vapor Specific Sensory Measurement
NCT04533542 COMPLETED
The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
NCT05555069 RECRUITING NA
Evaluating Selected Constituents in the Exhaled Breath Samples
NCT04143256 COMPLETED NA
Adolescent Vaping Characterization and Parent Views on Adolescent Vaping Protocol
NCT05669716 TERMINATED
Effects of Electronic Cigarettes on Nicotine Concentrations
NCT01775787 COMPLETED NA
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
NCT06260683 RECRUITING NA
Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency
NCT05430334 COMPLETED NA
The Interaction of Flavor With Nicotine Form in Adult Smokers
NCT04262817 COMPLETED PHASE1