MedDataX Logo

Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

NCT ID: NCT05932745

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2026-05-31

Brief Summary

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

This study is an examination of the influence of cooling components of WS-3, WS-23, and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults.

Detailed Description

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

The investigators will examine the influence of cooling components of WS-3, WS-23 (synthetic coolants) and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults. Participants will rate the flavor intensity, coolness, sweetness, and irritation/harshness, bitterness experienced using validated rating scales. 66 adult participants (18+ years of age) who are current e-cigarette users will participate in 3 laboratory sessions. Participants will be randomized to receive one of the 3 menthol conditions (no-menthol, low menthol, high menthol) in Lab 1 and will receive the alternative conditions in randomized order in Lab 2 and Lab 3. During each lab session the menthol condition will be paired with three WS-3 concentrations: no WS-3, low (0.1%) WS-3, or high (2.0%) WS-3 and three WS-23 concentrations: low (0.1%) WS-23, high (2.0%) WS-23, or 4% WS-23 in randomized order. All e-cigarettes will contain nicotine salt at a nicotine concentration of \~59mg/ml and all participants will be exposed to eighteen conditions across 3 lab sessions.

Conditions

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

Nicotine Use Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Menthol, cooling components, cigarette, e-cigarette, vaping

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

All participants receive all 18 study conditions.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Participants will be given a nicotine containing e-cigarette that could have various levels of cooling flavoring. Participants will not be told the nicotine concentration of the product or the type or concentration of the added coolant or what order it is presented in. Investigator and research assistant (i.e. care provider) will know the doses of nicotine and coolant, but will not know what order coolants are presented to participants.

Study Groups

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

Non-menthol, nicotine 59mg/ml (1)

Flavor without menthol with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (No WS-3) for non-menthol (1)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.

Low (0.1%) menthol, nicotine 59mg/ml (1)

Flavor with low menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (No WS-3) for low (0.1%) menthol (1)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.

High (2.0%) menthol, nicotine 59mg/ml (1)

Flavor with high menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (No WS-3) for high (2.0%) menthol (1)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.

Non-menthol, nicotine 59mg/ml (2)

Flavor without menthol with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.

Low (0.1%) menthol, nicotine 59mg/ml (2)

Flavor with low menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.

High (2.0%) menthol, nicotine 59mg/ml (2)

Flavor with high menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.

Non-menthol, nicotine 59mg/ml (3)

Flavor without menthol with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (High [2.0%] WS-3) for non-menthol (3)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.

Low (0.1%) menthol, nicotine 59mg/ml (3)

Flavor with low menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.

High (2.0%) menthol, nicotine 59mg/ml (3)

Flavor with high menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.

Non-menthol, nicotine 59mg/ml (4)

Flavor without menthol with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.

Low (0.1%) menthol, nicotine 59mg/ml (4)

Flavor low menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.

High (2.0%) menthol, nicotine 59mg/ml (4)

Flavor high menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.

Non-menthol, nicotine 59mg/ml (5)

Flavor without menthol with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (High [2.0%] WS-23) for non-menthol (5)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.

Low (0.1%) menthol, nicotine 59mg/ml (5)

Flavor low menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.

High (2.0%) menthol, nicotine 59mg/ml (5)

Flavor high menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.

Non-menthol, nicotine 59mg/ml (6)

Flavor without menthol with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (4% WS-23) for non-menthol (6)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.

Low (0.1%) menthol, nicotine 59mg/ml (6)

Flavor low menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (4% WS-23) for low (0.1%) menthol (6)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.

High (2.0%) menthol, nicotine 59mg/ml (6)

Flavor high menthol concentration with 59mg/ml nicotine

Group Type EXPERIMENTAL

E-liquid coolant (4% WS-23) for high (2.0%) menthol (6)

Intervention Type OTHER

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.

Interventions

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

E-liquid coolant (No WS-3) for non-menthol (1)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.

Intervention Type OTHER

E-liquid coolant (No WS-3) for low (0.1%) menthol (1)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.

Intervention Type OTHER

E-liquid coolant (No WS-3) for high (2.0%) menthol (1)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.

Intervention Type OTHER

E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.

Intervention Type OTHER

E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.

Intervention Type OTHER

E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.

Intervention Type OTHER

E-liquid coolant (High [2.0%] WS-3) for non-menthol (3)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.

Intervention Type OTHER

E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.

Intervention Type OTHER

E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.

Intervention Type OTHER

E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.

Intervention Type OTHER

E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.

Intervention Type OTHER

E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.

Intervention Type OTHER

E-liquid coolant (High [2.0%] WS-23) for non-menthol (5)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.

Intervention Type OTHER

E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.

Intervention Type OTHER

E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.

Intervention Type OTHER

E-liquid coolant (4% WS-23) for non-menthol (6)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.

Intervention Type OTHER

E-liquid coolant (4% WS-23) for low (0.1%) menthol (6)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.

Intervention Type OTHER

E-liquid coolant (4% WS-23) for high (2.0%) menthol (6)

Adult users of e-cigarette will be exposed to distinct e-liquid coolants with 4% WS-23 concentration.

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

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
* Some current e-cigarette use
* Urine cotinine ≥200ng/ml
* Willing to abstain from tobacco/nicotine use 2 hours prior to sessions

Exclusion Criteria

* Current use of non-prescription substances besides nicotine, marijuana, alcohol
* Any significant current medical or psychiatric condition
* 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.

JB Pierce Lab

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Danielle Davis, PhD

Role: CONTACT

Phone: 203-974-7607

Email: [email protected]

Wei Li, PhD

Role: CONTACT

Email: [email protected]

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)

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_b

Identifier Type: -

Identifier Source: org_study_id