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Recruiting NCT05932745

Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

No phase Interventional Nicotine Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Nicotine Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Other E-liquid coolant (No WS-3) for low (0.1%) menthol (1)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
  • Other E-liquid coolant (No WS-3) for high (2.0%) menthol (1)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants without WS-3.
  • Other E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
  • Other E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
  • Other E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-3 concentration.
  • Other E-liquid coolant (High [2.0%] WS-3) for non-menthol (3)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
  • Other E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
  • Other E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with high WS-3 concentration.
  • Other E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4)
    Adult users of e-cigarette will be exposed to distinct e-liquid coolants with low WS-23 concentration.

Primary outcome measures

  • 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)]
  • 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)]
  • 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)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • JB Pierce Lab — New Haven

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. PMID 19833660

Identifiers

NCT: NCT05932745 · 2000035551_b · 2U54DA036151-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗