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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05932745
Other study ID # 2000035551_b
Secondary ID 2U54DA036151-11
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2024
Est. completion date November 2025

Study information

Verified date May 2024
Source Yale University
Contact Danielle Davis, PhD
Phone 203-974-7607
Email danielle.davis@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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 receive 3 e-cigarette that contain cooling flavors and nicotine (59mg/ml nicotine salt) during the sessions. Participants will be randomized to receive one of the 3 menthol conditions (no-menthol, low menthol, high menthol) in combination three WS-3 conditions (no WS-3, low WS-3, high WS-3) and two WS-23 conditions (low WS-23, high WS-23). All participants will be exposed to all fifteen conditions across 3 lab sessions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older - Able to read and write - Some current e-cigarette use - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
E-liquid coolant (No WS-3) for low menthol (1)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
E-liquid coolant (No WS-3) for high menthol (1)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
E-liquid coolant (Low WS-3) for non-menthol (2)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (Low WS-3) for low menthol (2)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (Low WS-3) for high menthol (2)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
E-liquid coolant (High WS-3) for non-menthol (3)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (High WS-3) for low menthol (3)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (High WS-3) for high menthol (3)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
E-liquid coolant (Low WS-23) for non-menthol (4)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (Low WS-23) for low menthol (4)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (Low WS-23) for high menthol (4)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.
E-liquid coolant (High WS-23) for non-menthol (5)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.
E-liquid coolant (High WS-23) for low menthol (5)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.
E-liquid coolant (High WS-23) for high menthol (5)
Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-23 concentration.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 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 5 (at 130 minutes)
Primary 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). 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 5 (at 130 minutes)
Primary 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). 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 5 (at 130 minutes)
Secondary 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). 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 5 (at 130 minutes)
Secondary Changes of salivary Nicotine and Cotinine Levels from baseline at each e-cigarette condition (5 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. 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 5 (at 130 minutes)
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