Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05932745
Status
Recruiting

Conditions

  • Nicotine Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Non-menthol, nicotine 59mg/ml (1)
    Flavor without menthol with 59mg/ml nicotine
  • Experimental: Low (0.1%) menthol, nicotine 59mg/ml (1)
    Flavor with low menthol concentration with 59mg/ml nicotine
  • Experimental: High (2.0%) menthol, nicotine 59mg/ml (1)
    Flavor with high menthol concentration with 59mg/ml nicotine
  • Experimental: Non-menthol, nicotine 59mg/ml (2)
    Flavor without menthol with 59mg/ml nicotine
  • Experimental: Low (0.1%) menthol, nicotine 59mg/ml (2)
    Flavor with low menthol concentration with 59mg/ml nicotine
  • Experimental: High (2.0%) menthol, nicotine 59mg/ml (2)
    Flavor with high menthol concentration with 59mg/ml nicotine
  • Experimental: Non-menthol, nicotine 59mg/ml (3)
    Flavor without menthol with 59mg/ml nicotine
  • Experimental: Low (0.1%) menthol, nicotine 59mg/ml (3)
    Flavor with low menthol concentration with 59mg/ml nicotine
  • Experimental: High (2.0%) menthol, nicotine 59mg/ml (3)
    Flavor with high menthol concentration with 59mg/ml nicotine
  • Experimental: Non-menthol, nicotine 59mg/ml (4)
    Flavor without menthol with 59mg/ml nicotine
  • Experimental: Low (0.1%) menthol, nicotine 59mg/ml (4)
    Flavor low menthol concentration with 59mg/ml nicotine
  • Experimental: High (2.0%) menthol, nicotine 59mg/ml (4)
    Flavor high menthol concentration with 59mg/ml nicotine
  • Experimental: Non-menthol, nicotine 59mg/ml (5)
    Flavor without menthol with 59mg/ml nicotine
  • Experimental: Low (0.1%) menthol, nicotine 59mg/ml (5)
    Flavor low menthol concentration with 59mg/ml nicotine
  • Experimental: High (2.0%) menthol, nicotine 59mg/ml (5)
    Flavor high menthol concentration with 59mg/ml nicotine
  • Experimental: Non-menthol, nicotine 59mg/ml (6)
    Flavor without menthol with 59mg/ml nicotine
  • Experimental: Low (0.1%) menthol, nicotine 59mg/ml (6)
    Flavor low menthol concentration with 59mg/ml nicotine
  • Experimental: High (2.0%) menthol, nicotine 59mg/ml (6)
    Flavor high menthol concentration with 59mg/ml nicotine

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
JB Pierce LabNew HavenConnecticut06519-

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