Nicotine Use DisorderNCT05932745
Effects of Novel E-cigarette Constituents on Adults TCORS 3.0
A study testing E-liquid coolant (No WS-3) for non-menthol (1), E-liquid coolant (No WS-3) for low (0.1%) menthol (1) and E-liquid coolant (No WS-3) for high (2.0%) menthol (1) in people with Nicotine Use Disorder, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Use Disorder
- What is being tested?
- E-liquid coolant (No WS-3) for non-menthol (1), E-liquid coolant (No WS-3) for low (0.1%) menthol (1) and E-liquid coolant (No WS-3) for high (2.0%) menthol (1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wei Li, PhD contact
United States1 site, 1 recruiting
- Recruiting
JB Pierce Lab
New Haven, Connecticut, 06519
About this study
Official title: Examining Appeal and Addiction Potential of Novel E-cigarette Constituents Among Adults
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.
Read the detailed description
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
- Nicotine Use Disorder
- Being tested
- E-liquid coolant (No WS-3) for non-menthol (1), E-liquid coolant (No WS-3) for low (0.1%) menthol (1), E-liquid coolant (No WS-3) for high (2.0%) menthol (1), E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2), E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2)
- Keywords
- Menthol, cooling components, cigarette, e-cigarette, vaping
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-liquid coolant (No WS-3) for non-menthol (1)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
E-liquid coolant (No WS-3) for low (0.1%) menthol (1)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
E-liquid coolant (No WS-3) for high (2.0%) menthol (1)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (High [2.0%] WS-3) for non-menthol (3)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (High [2.0%] WS-23) for non-menthol (5)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.
E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.
E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5)Other
Also called Flavor type
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-menthol, nicotine 59mg/ml (1) | Experimental | Flavor without menthol with 59mg/ml nicotine Receives: Other: E-liquid coolant (No WS-3) for non-menthol (1) |
| Low (0.1%) menthol, nicotine 59mg/ml (1) | Experimental | Flavor with low menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (No WS-3) for low (0.1%) menthol (1) |
| High (2.0%) menthol, nicotine 59mg/ml (1) | Experimental | Flavor with high menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (No WS-3) for high (2.0%) menthol (1) |
| Non-menthol, nicotine 59mg/ml (2) | Experimental | Flavor without menthol with 59mg/ml nicotine Receives: Other: E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2) |
| Low (0.1%) menthol, nicotine 59mg/ml (2) | Experimental | Flavor with low menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2) |
| High (2.0%) menthol, nicotine 59mg/ml (2) | Experimental | Flavor with high menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2) |
| Non-menthol, nicotine 59mg/ml (3) | Experimental | Flavor without menthol with 59mg/ml nicotine Receives: Other: E-liquid coolant (High [2.0%] WS-3) for non-menthol (3) |
| Low (0.1%) menthol, nicotine 59mg/ml (3) | Experimental | Flavor with low menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3) |
| High (2.0%) menthol, nicotine 59mg/ml (3) | Experimental | Flavor with high menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3) |
| Non-menthol, nicotine 59mg/ml (4) | Experimental | Flavor without menthol with 59mg/ml nicotine Receives: Other: E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4) |
| Low (0.1%) menthol, nicotine 59mg/ml (4) | Experimental | Flavor low menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4) |
| High (2.0%) menthol, nicotine 59mg/ml (4) | Experimental | Flavor high menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4) |
| Non-menthol, nicotine 59mg/ml (5) | Experimental | Flavor without menthol with 59mg/ml nicotine Receives: Other: E-liquid coolant (High [2.0%] WS-23) for non-menthol (5) |
| Low (0.1%) menthol, nicotine 59mg/ml (5) | Experimental | Flavor low menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5) |
| High (2.0%) menthol, nicotine 59mg/ml (5) | Experimental | Flavor high menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5) |
| Non-menthol, nicotine 59mg/ml (6) | Experimental | Flavor without menthol with 59mg/ml nicotine Receives: Other: E-liquid coolant (4% WS-23) for non-menthol (6) |
| Low (0.1%) menthol, nicotine 59mg/ml (6) | Experimental | Flavor low menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (4% WS-23) for low (0.1%) menthol (6) |
| High (2.0%) menthol, nicotine 59mg/ml (6) | Experimental | Flavor high menthol concentration with 59mg/ml nicotine Receives: Other: E-liquid coolant (4% WS-23) for high (2.0%) menthol (6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liking: Score change in liking/wanting of each e-cigarette condition (5 conditions in total)
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).
Measured: 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)
Reinforcing Efficacy: Score change in drug effects of each e-cigarette condition (5 conditions in total)
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).
Measured: 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)
Irritation/Harshness: Score change in irritation of harshness of each e-cigarette condition (5 conditions in total)
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).
Measured: 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)
Secondary outcomes (2)
Craving: Change in craving score for e-cigarette from baseline at each e-cigarette condition (5 conditions in total)
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).
Measured: 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)
Changes of salivary Nicotine and Cotinine Levels from baseline at each e-cigarette condition (6 conditions in total)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start20 Jun 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants receive all 18 study conditions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Suchitra Krishnan-Sarin, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932745
- Sponsor's protocol ID
- 2000035551_b
- Other IDs
- 2U54DA036151-11
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
Publications
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.
PubMed 19833660
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Appeal and Addiction Potential of Novel E-cigarette Constituents Among Adults
- ClinicalTrials.gov ID
- NCT05932745
- Acronym / sponsor ID
- 2000035551_b
- Conditions
- Nicotine Use Disorder
- Keywords
- Menthol, cooling components, cigarette, e-cigarette, vaping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 18
- Model description
- All participants receive all 18 study conditions.
| Arm | Type | Receives |
|---|---|---|
| Non-menthol, nicotine 59mg/ml (1) | Experimental | Other: E-liquid coolant (No WS-3) for non-menthol (1)Flavor without menthol with 59mg/ml nicotine |
| Low (0.1%) menthol, nicotine 59mg/ml (1) | Experimental | Other: E-liquid coolant (No WS-3) for low (0.1%) menthol (1)Flavor with low menthol concentration with 59mg/ml nicotine |
| High (2.0%) menthol, nicotine 59mg/ml (1) | Experimental | Other: E-liquid coolant (No WS-3) for high (2.0%) menthol (1)Flavor with high menthol concentration with 59mg/ml nicotine |
| Non-menthol, nicotine 59mg/ml (2) | Experimental | Other: E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2)Flavor without menthol with 59mg/ml nicotine |
| Low (0.1%) menthol, nicotine 59mg/ml (2) | Experimental | Other: E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2)Flavor with low menthol concentration with 59mg/ml nicotine |
| High (2.0%) menthol, nicotine 59mg/ml (2) | Experimental | Other: E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2)Flavor with high menthol concentration with 59mg/ml nicotine |
| Non-menthol, nicotine 59mg/ml (3) | Experimental | Other: E-liquid coolant (High [2.0%] WS-3) for non-menthol (3)Flavor without menthol with 59mg/ml nicotine |
| Low (0.1%) menthol, nicotine 59mg/ml (3) | Experimental | Other: E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3)Flavor with low menthol concentration with 59mg/ml nicotine |
| High (2.0%) menthol, nicotine 59mg/ml (3) | Experimental | Other: E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3)Flavor with high menthol concentration with 59mg/ml nicotine |
| Non-menthol, nicotine 59mg/ml (4) | Experimental | Other: E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4)Flavor without menthol with 59mg/ml nicotine |
| Low (0.1%) menthol, nicotine 59mg/ml (4) | Experimental | Other: E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4)Flavor low menthol concentration with 59mg/ml nicotine |
| High (2.0%) menthol, nicotine 59mg/ml (4) | Experimental | Other: E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4)Flavor high menthol concentration with 59mg/ml nicotine |
| Non-menthol, nicotine 59mg/ml (5) | Experimental | Other: E-liquid coolant (High [2.0%] WS-23) for non-menthol (5)Flavor without menthol with 59mg/ml nicotine |
| Low (0.1%) menthol, nicotine 59mg/ml (5) | Experimental | Other: E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5)Flavor low menthol concentration with 59mg/ml nicotine |
| High (2.0%) menthol, nicotine 59mg/ml (5) | Experimental | Other: E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5)Flavor high menthol concentration with 59mg/ml nicotine |
| Non-menthol, nicotine 59mg/ml (6) | Experimental | Other: E-liquid coolant (4% WS-23) for non-menthol (6)Flavor without menthol with 59mg/ml nicotine |
| Low (0.1%) menthol, nicotine 59mg/ml (6) | Experimental | Other: E-liquid coolant (4% WS-23) for low (0.1%) menthol (6)Flavor low menthol concentration with 59mg/ml nicotine |
| High (2.0%) menthol, nicotine 59mg/ml (6) | Experimental | Other: E-liquid coolant (4% WS-23) for high (2.0%) menthol (6)Flavor high menthol concentration with 59mg/ml nicotine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-liquid coolant (No WS-3) for non-menthol (1)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3. | Other | Non-menthol, nicotine 59mg/ml (1) |
| E-liquid coolant (No WS-3) for low (0.1%) menthol (1)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3. | Other | Low (0.1%) menthol, nicotine 59mg/ml (1) |
| E-liquid coolant (No WS-3) for high (2.0%) menthol (1)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3. | Other | High (2.0%) menthol, nicotine 59mg/ml (1) |
| E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration. | Other | Non-menthol, nicotine 59mg/ml (2) |
| E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration. | Other | Low (0.1%) menthol, nicotine 59mg/ml (2) |
| E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration. | Other | High (2.0%) menthol, nicotine 59mg/ml (2) |
| E-liquid coolant (High [2.0%] WS-3) for non-menthol (3)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration. | Other | Non-menthol, nicotine 59mg/ml (3) |
| E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration. | Other | Low (0.1%) menthol, nicotine 59mg/ml (3) |
| E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration. | Other | High (2.0%) menthol, nicotine 59mg/ml (3) |
| E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration. | Other | Non-menthol, nicotine 59mg/ml (4) |
| E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration. | Other | Low (0.1%) menthol, nicotine 59mg/ml (4) |
| E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration. | Other | High (2.0%) menthol, nicotine 59mg/ml (4) |
| E-liquid coolant (High [2.0%] WS-23) for non-menthol (5)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration. | Other | Non-menthol, nicotine 59mg/ml (5) |
| E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration. | Other | Low (0.1%) menthol, nicotine 59mg/ml (5) |
| E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5)Also: Flavor typeAdult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration. | Other | High (2.0%) menthol, nicotine 59mg/ml (5) |
| 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. | Other | Non-menthol, nicotine 59mg/ml (6) |
| 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. | Other | Low (0.1%) menthol, nicotine 59mg/ml (6) |
| 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. | Other | High (2.0%) menthol, nicotine 59mg/ml (6) |
Primary outcome
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).
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).
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).
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 19833660Lim 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.
- Individual participant dataSharing planned: Yes. We may share information about the IPD and study results with other researchers in the future, but the information will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Li, PhD contact
Suchitra Krishnan-Sarin, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-liquid coolant (No WS-3) for non-menthol (1), E-liquid coolant (No WS-3) for low (0.1%) menthol (1) and E-liquid coolant (No WS-3) for high (2.0%) menthol (1) in people with Nicotine Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Davis, PhD (203-974-7607, danielle.davis@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.