Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

Yale University

Status: Enrolling

Conditions: Nicotine Use Disorder

Treatments: Other: E-liquid coolant (4% WS-23) for low (0.1%) menthol (6); Other: E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5); Other: E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2); Other: E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4); Other: E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5); Other: E-liquid coolant (4% WS-23) for high (2.0%) menthol (6); Other: E-liquid coolant (No WS-3) for low (0.1%) menthol (1); Other: E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4); Other: E-liquid coolant (No WS-3) for non-menthol (1); Other: E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3); Other: E-liquid coolant (No WS-3) for high (2.0%) menthol (1); Other: E-liquid coolant (High [2.0%] WS-3) for non-menthol (3); Other: E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3); Other: E-liquid coolant (4% WS-23) for non-menthol (6); Other: E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2); Other: E-liquid coolant (High [2.0%] WS-23) for non-menthol (5); Other: E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4); Other: E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05932745

2000035551_b

2U54DA036151-11 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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66 participants in 18 patient groups

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

Experimental group

Description:

Flavor without menthol with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor with low menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor with high menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor without menthol with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor with low menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor with high menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor without menthol with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor with low menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor with high menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor without menthol with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor low menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor high menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor without menthol with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor low menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor high menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor without menthol with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor low menthol concentration with 59mg/ml nicotine

Treatment:

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

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

Experimental group

Description:

Flavor high menthol concentration with 59mg/ml nicotine

Treatment:

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