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Идёт набор NCT06089980

Direct Observation Study of Kratom Product Effects Among Regular Consumers

— Наблюдательное Kratom Pharmacokinetics Kratom Pharmacodynamics Kratom

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: Effects from acute kratom exposure.
Кому может быть актуально
Состояния в реестре: Kratom Pharmacokinetics, Kratom Pharmacodynamics, Kratom. Базовые параметры: от 21 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

Observing the Acute Effects Following a Single Oral Dose of Kratom and Effects Following Kratom Cessation Among Adults Who Use Regularly.

Обзор

The goal of this observational clinical study is to is to learn more about how commercial kratom products affect healthy adults who consume them regularly. The main questions it aims to answer are: 1. What are the acute physiological, subjective, and cognitive effects of kratom following participant self-administration of a single oral dose of the participants usual kratom product at the participants typical dose? 2. What are the physiological, subjective, and cognitive effects associated with kratom product discontinuation among adults who use regularly? 3. What are the pharmacokinetics of kratom products consumed by adults who use regularly? On the first study day: Under direct observation, participants will self-administer a single oral dose of the participants own commercial kratom product that that is regularly taken and will consume it at the participants self-selected typical dose/serving. Following this, serial blood draws and urine collection will occur along with administration of validated questionnaires, tests, and continual monitoring. After this first study day, participants will no longer be permitted to use any of the participants kratom product during the study. On study nights/days 2-3: participants will reside a clinical research unit and be observed and evaluated for kratom withdrawal syndrome.

Вмешательства

  • Поведенческое Effects from acute kratom exposure
    Participants who regularly use commercial Kratom products will orally consume a known quantity of kratom under direct observation on first study day; following this, participants will stop kratom use for approximately 2 nights and 2.5 days for the duration of the study.

Первичные конечные точки

  • Peak subjective opioid withdrawal score [Срок оценки: Up to 3 days]
  • Time in minutes until a Subjective Opioid Withdrawal (SOWS) score of more than 11 is reached [Срок оценки: up to 3 days]
  • Peak rating and changes in rating on Drug Effects Questionnaire (primary subjective outcome) [Срок оценки: Up to 3 days]
  • Peak rating and change in rating on Drug Effects Questionnaire (primary subjective outcome) [Срок оценки: Up to 3 days]
  • Changes in accuracy on psychomotor task (primary cognitive outcome) [Срок оценки: Up to 3 days]
  • Pupil diameter nadir size as measured in millimeters (mm) (primary physiological outcome). [Срок оценки: Up to 3 days]

Критерии участия

Критерии включения

  • >21 years
  • reporting kratom use >5 times per week for >3 months prior to study screening
  • English language proficiency
  • Willingness to provide requested samples of the kratom product being currently taken

Критерии исключения

  • Reports any acute adverse, unexpected, or otherwise sudden health event related to the typical kratom product dose that occurred within 30 days of screening
  • Having ever sought medical attention for an acute adverse health event as a result of taking any kratom product.
  • Cannot or will not provide kratom product samples in the form of an unopened package of kratom that is clearly labeled with at least the product and vendor name.
  • Self-reports using kratom products by any other route than orally swallowing.
  • Current physical dependence on alcohol, benzodiazepines, or opioids
  • Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen.
  • Discordance between self-reported substance use and drug screen results obtained during screening.
  • Lifetime or current psychotic disorder
  • Current untreated major depressive or bipolar disorder
  • Pregnancy or nursing
  • Physical, psychiatric, or environmental conditions considered by study team to increase risk or undue burden (e.g., untreated hypertension, high BMI, etc.).

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Johns Hopkins University — Baltimore

Идентификаторы

NCT: NCT06089980 · IRB00408134 · R00DA055571

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗