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Идёт набор NCT05932745

Effects of Novel E-cigarette Constituents on Adults TCORS 3.0

Без фазы С лечением Nicotine Use Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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).
Кому может быть актуально
Состояния в реестре: Nicotine Use Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Liking: Score change in liking/wanting of each e-cigarette condition (5 conditions in total) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]
Вторичные конечные точки (2)
  • Craving: Change in craving score for e-cigarette from baseline at each e-cigarette condition (5 conditions in total) [Срок оценки: 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) [Срок оценки: 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)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • JB Pierce Lab — New Haven

Публикации

  • 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

Идентификаторы

NCT: NCT05932745 · 2000035551_b · 2U54DA036151-11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗