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Идёт набор NCT07444788

Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants

Фаза I С лечением 5-methoxy-dimethyltryptamine (5-MeO-DMT)

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: 0.2 mg/min 5-MeO-DMT, 0.4 mg/min 5-MeO-DMT, 0.6 mg/min 5-MeO-DMT, 0.8 mg/min 5-MeO-DMT.
Кому может быть актуально
Состояния в реестре: 5-methoxy-dimethyltryptamine (5-MeO-DMT). Базовые параметры: 25 лет — 65 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
Швейцария
Следующий шаг
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Официальное название

Acute Subjective Effects, Physiological Effects, and Pharmacokinetics of Intravenous 5-MeO-DMT Infusions in a Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Participants

Обзор

Participation in this study lasts approximately two weeks and includes three on-site study visits: a screening visit (approximately 2 hours), a study drug administration visit (approximately 4 hours), and a follow-up visit approximately one week later (approximately 2 hours). If participants decide to take part in the study and meet the inclusion and exclusion criteria, they will be randomly assigned to one of two groups: an experimental group or a control group. Participants will not be informed of your group assignment. Participants in the experimental group will receive the investigational substance 5-MeO-DMT at a dose of 0.2, 0.4, 0.6, or 0.8 mg/min for a total infusion duration of 30 min. Participants in the control group will receive a placebo that is indistinguishable in appearance from the investigational substance. Following substance administration, participants will be repeatedly asked to describe their subjective experiences. Blood pressure and heart rate will be monitored regularly, and blood samples will be collected via an intravenous catheter.

Вмешательства

  • Препарат 0.2 mg/min 5-MeO-DMT
    0.2 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
  • Препарат 0.4 mg/min 5-MeO-DMT
    0.4 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
  • Препарат 0.6 mg/min 5-MeO-DMT
    0.6 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
  • Препарат 0.8 mg/min 5-MeO-DMT
    0.8 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
  • Препарат Placebo
    Placebo (saline) is administered for a total infusion duration of 30 min.

Первичные конечные точки

  • Change in subjective effects over time (assessed with subjective effect scales (SES)) [Срок оценки: Up to 245 minutes at the substance administration session (Session 2): 1 hour and 5 minutes before and 5, 10, 15, 20, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 min after substance administration.]
Вторичные конечные точки (12)
  • Treatment-emergent adverse events (TEAEs) [Срок оценки: Up to one week (from substance administration session (Session 2) to end of study visit (EOS, Session 3))]
  • Change in Safety lab parameters [Срок оценки: Up to 14 days (from Screening (Session 1) until end-of-study-visit (EOS, Session 3))]
  • Change in Vital Signs [Срок оценки: Up to 245 minutes at the substance administration session (Session 2): 1 hour and 5 minutes before and 5, 10, 15, 20, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 min after substance administration.]
  • Change in Adverse effects list (Beschwerdenliste (BL-R) [Срок оценки: Up to 4 hours at substance administration session (Session 2) (at baseline and after substance administration)]
  • Swiss Psychedelic Side Effects Inventory (SPSI) [Срок оценки: One time assessment at End-of-study-visit (EOS, Session 3 = 7 days after substance administration)]
  • Change in Columbia-Suicide-Severity-Rating-Scale (C-SSRS) [Срок оценки: Up to 14 days (from Screening (Session 1) to Substance administration session (Session 2) until End-of-study-visit (EOS, Session 3))]
  • 5-Dimensions of Altered States of Consciousness Scale (5D-ASC) [Срок оценки: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • States of Consciousness Questionnaire (SCQ) [Срок оценки: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • Ego dissolution inventory (EDI) [Срок оценки: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • Near-death experience content scale (NDE-C) [Срок оценки: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • Emotional Breakthrough Inventory Plus (EBI+) [Срок оценки: One time assessment at substance administration session (Session 2): 3 hours after substance administration]
  • PAE-PS-ext (PAE-PS-ext) [Срок оценки: One time assessment at substance administration session (Session 2): 3 hours after substance administration.]

Критерии участия

Критерии включения

  • Age between 25 and 65 years old
  • Sufficient understanding of the German language
  • Understanding of procedures and risks associated with the study
  • Willing to adhere to the protocol and signing of the consent form
  • Willing to refrain from the consumption of illicit psychoactive substances during the study
  • Willing not to operate heavy machinery for 48 hours after the study session.
  • Willing to use effective birth control throughout study participation
  • Body mass index between 18-29 kg/m2

Критерии исключения

  • Chronic or acute medical condition
  • Current or previous major psychiatric disorder
  • Psychotic disorder or bipolar disorder in first-degree relatives
  • Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • Hallucinogenic and/or dissociative substance use (not including cannabis) more than 20 times or any time within the previous two months
  • Pregnancy or current breastfeeding
  • Participation in another clinical trial (currently or within the last 30 days)
  • Use of medication that may interfere with the effects of the study medication
  • Tobacco smoking (>10 cigarettes/day)
  • Consumption of alcoholic beverages (>15 drinks or >180g alcohol per week)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Другое

Центры проведения

Швейцария · 1 центр
  • University Hospital Basel — Basel

Идентификаторы

NCT: NCT07444788 · 2025-02387;am25Vogt2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗