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Набор по приглашению NCT05570708

The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training

Без фазы С лечением Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD

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: MDMA, LSD, psilocybin.
Кому может быть актуально
Состояния в реестре: Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD. Базовые параметры: от 27 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The study investigates two groups of participants of the SÄPT therapist's training starting in October 2022. The overall objective is to investigate the risks and benefits of personal experience (PE) with substance-induced altered states of consciousness for physicians or psychotherapists in the context of a training course for substance-assisted therapy. Specifically, the study aims to assess changes in therapeutic attitude and other factors important in interactions between patients and therapists (such as empathy and cognitive flexibility).

Вмешательства

  • Препарат MDMA, LSD, psilocybin
    * MDMA per os (2 x 100mg) in a group setting * LSD per os (75 and 150 mcg) in a 1:1 setting * Psilocybin per os (15 mg and 25 mg) in a group setting * Three study days are without drug administration: Participants experience the role of the therapist in a 1:1 setting

Первичные конечные точки

  • TASC-2 scale [Срок оценки: Three weeks after last PE]
Вторичные конечные точки (12)
  • semi-structured interview [Срок оценки: Five months after last PE]
  • TASC-2 scale [Срок оценки: Three weeks after each PE and six months after last PE]
  • SOCS-S [Срок оценки: Three weeks after each PE and six months after last PE]
  • SPCS-O [Срок оценки: Three weeks after each PE and six months after last PE]
  • SPF/IRI [Срок оценки: Three weeks after each PE and six months after last PE]
  • 5D-ASC [Срок оценки: Directly after each PE]
  • CEQ [Срок оценки: Directly after each PE]
  • APEQ [Срок оценки: Directly after each PE]
  • PIQ [Срок оценки: Directly after each PE]
  • CSOWD [Срок оценки: Directly after each PE]
  • EBI [Срок оценки: Directly after each PE]
  • BFW/E [Срок оценки: Three weeks after each PE and six months after last PE]

Критерии участия

Критерии включения

  • Participation in the SÄPT therapist training (medical doctors and psychologists)
  • Age 27 years or older
  • 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 not to operate heavy machinery (including driving cars) within 24 hours after substance administration
  • Woman of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository at least one month before and after each study substance intervention, and are willing to take a urine pregnancy test at the medical screening and before every study substance intervention.
  • Men are required to use contraceptive methods in the month after each study substance intervention and are required to inform their partner(s) about their study participation.

Критерии исключения

  • Previous significant adverse response to a hallucinogenic drug
  • Significant medical condition rendering volunteers unsuitable for participation (such as impaired kidney or liver function, or heart disease incl. uncontrolled hypertension or hypotension)
  • Strong underweight (<45kg)
  • Current major psychiatric disorder (including personality disorder, including suicidality) and / or previous psychotic or bipolar disorder.
  • Psychotic disorder or bipolar disorder in first-degree relatives
  • Use of medication that may interfere with the effects of the study medication. Patients must be willing to discontinue medications in cases where drug-related interactions are possible (the washout phase will be at least 5 times the particular drug's half-life \[typically 3-7 days\] prior to the respective study session). Discontinuation of medication must be judged to be acceptable by the responsible investigator.
  • Women are excluded from substance intervention during pregnancy or breastfeeding.
  • nParticipation in another clinical trial (currently or within the last 30 days)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Швейцария · 1 центр
  • University Hospital Basel — Basel

Идентификаторы

NCT: NCT05570708 · 2022-01173

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗