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NCT Number: NCT05932745

Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

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.

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Key information

Conditions

Nicotine Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JB Pierce Lab

New Haven, Connecticut, 06519, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

Other names: Flavor type

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

Other

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

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

Other

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

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

Other

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

Primary outcomes

  1. Liking: Score change in liking/wanting of each e-cigarette condition (5 conditions in total)

    Time frame: Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes)

    The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking).

  2. Reinforcing Efficacy: Score change in drug effects of each e-cigarette condition (5 conditions in total)

    Time frame: Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes)

    Difference between e-cigarette effects for each e-cigarette condition as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm).

  3. Irritation/Harshness: Score change in irritation of harshness of each e-cigarette condition (5 conditions in total)

    Time frame: Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes)

    Difference in 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).

Secondary outcomes

  1. Craving: Change in craving score for e-cigarette from baseline at each e-cigarette condition (5 conditions in total)

    Time frame: At baseline (at 0 minute), following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes)

    Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e cigarettes 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).

  2. Changes of salivary Nicotine and Cotinine Levels from baseline at each e-cigarette condition (6 conditions in total)

    Time frame: At baseline (at 0 minute), Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes)

    Saliva samples will be collected following each exposure to product and before each lab sessions to assess change in nicotine/cotinine levels. These levels will be used for correlational analyses with behavioral measures and will be determined using LC/MS techniques at the core laboratory of university.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Davis, PhD

CONTACT

[email protected]

203-974-7607

Wei Li, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Examining Appeal and Addiction Potential of Novel E-cigarette Constituents Among Adults

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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