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Набор скоро начнётся NCT07694466

Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis

Ранняя фаза I С лечением Cannabis Use Tobacco Biomarkers

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: Cannabis (THC), Tobacco Cigarette.
Кому может быть актуально
Состояния в реестре: Cannabis Use, Tobacco, Biomarkers. Базовые параметры: 18 лет — 55 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Lung Health and Breath Biomarkers: Acute Effects of Combusted and Vaporized Cannabis Inhalation Compared to Tobacco Cigarette Combustion in the Human Laboratory

Обзор

This outpatient study examines how inhaled cannabis, combustible or vaporized, alters lung health and breath biomarkers compared to a tobacco cigarette.

Вмешательства

  • Препарат Cannabis (THC)
    Active Cannabis (THC) will be inhaled.
  • Препарат Tobacco Cigarette
    A leading brand of tobacco cigarette (\~1.0 gram; Marlboro Gold; Phillip Morris International)

Первичные конечные точки

  • Exhaled Breath Condensate (EBC) [Срок оценки: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration]
  • Breath Volatile Organic Compound (BVOC) [Срок оценки: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration]
  • Exhaled Nitric Oxide (FeNO) [Срок оценки: Baseline (prior to study drug admission), approximately 25, 40,60, 90, 120 and 180 minutes after drug administration]
Вторичные конечные точки (2)
  • Cigarette Evaluation Questionnaire (CEQ) [Срок оценки: Immediately following administration of combusted tobacco or cannabis cigarette (approximately 10 minutes after drug administration)]
  • Modified Cigarette Evaluation Questionnaire (mCEQ) [Срок оценки: Immediately following administration of vaporized cannabis (approximately 10 minutes after drug administration)]

Критерии участия

Критерии включения

  • English-speaking,
  • Literate adults,
  • Male or female,
  • Between the ages of 18 and 55,
  • Body Mass Index from 18.5 and 32.0 kg/m2,
  • Able to provide written informed consent and perform all study procedures,
  • Current recreational cannabis users - must report past 30-day cannabis use and at least 5 exposures in the past year (minimum use criteria); no limit on maximum use,
  • Past year history of vaporized or smoked cannabis use to intoxication,
  • Past 30-day use of combusted tobacco,
  • Not currently seeking treatment for cannabis, tobacco cigarettes, or other drug use,
  • If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method),
  • Negative urine drug test for drugs of abuse (other than cannabis) before every Laboratory Session, and
  • Otherwise, healthy as determined by the investigator based on medical history, physical examination, vital signs, laboratory chemistries (blood chemistry with liver function tests and hematology, urinalysis, and microscopic evaluation, 12-lead electrocardiogram).

Критерии исключения

  • Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,
  • Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders \[e.g., asthma, COPD\]),
  • Existing or significant lung health problems that could interfere with the study,
  • Current or history of major psychiatric disorder that would limit the participant's ability to participate in the study (e.g., bipolar disorder),
  • Exclusive use of tobacco or cannabis through vapes and Electronic Nicotine Delivery Systems (ENDS) products,
  • Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study (as determined by the study physician),
  • Clinically significant abnormal ECG (as determined by study physician/cardiologist),
  • Clinically significant abnormal laboratory findings (e.g., liver function tests greater than 3x the upper limits of normal range),
  • History of seizure disorder,
  • Clinically significant history of head injuries requiring medical management or long-lasting sequelae.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Kentucky — Lexington

Идентификаторы

NCT: NCT07694466 · 111900

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗