Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

Nicotine Use Disorder Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Nicotine Use Disorder
• Tobacco Use Disorder

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)