Subjective Experience Following Psilocybin

Официальное название

The Role of the Subjective Experience in Supporting Positive Effects Following Psilocybin: a Randomized, Controlled Clinical Trial Using Risperidone in Healthy Adults

Обзор

The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of "magic mushrooms") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects of psilocybin.

Подробное описание

The overall goal of this clinical trial is to systematically explore the relationship between the subjective psychedelic experience, improvements in well-being, and the stress response following psilocybin administration.

The investigators aim to determine whether blocking the acute subjective effects (via risperidone) will influence the acute or protracted effects of psilocybin as measured via self-report, biochemical, or psychophysiological measures. The study also aims to determine if individual variability in stress reactivity or regulation predicts acute (day of dosing) or protracted (1-week later) effects of psilocybin.

A single site will recruit 128 participants aged 18 to 65 who do not meet criteria for any psychiatric diagnoses. A series of questionnaires, blood labs, and medical exams including electrocardiogram will determine inclusion into the study. Once accepted into the study, participants will complete baseline measures assessing biomarkers such as cortisol and brain-derived neurotrophic factor (BDNF) levels, cognitive flexibility, mood, well-being, personality traits, and anxiety levels.

Participants will then be randomly assigned into one of the following groups:

i) high dose psilocybin in combination with placebo pretreatment ii) high dose psilocybin in combination with risperidone pretreatment iii) low dose psilocybin in combination with placebo pretreatment iv) low dose psilocybin in combination with risperidone pretreatment

Outcome measures will be assessed at 1-week and 1-month after each dosing session.

Вмешательства

• Препарат Psilocybin high-dose
  The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the high-dose
• Препарат Psilocybin low-dose
  The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the low-dose.
• Препарат Risperidone 1 MG
  risperidone 1mg capsules
• Препарат Placebo
  inactive placebo

Первичные конечные точки

• Positive effects [Срок оценки: One week and one month post-dosing]

Вторичные конечные точки (8)

• Stress reactivity [Срок оценки: From start of dosing session to end of dosing session]
• Biomarkers of stress and plasticity [Срок оценки: from baseline to dosing session (one week post-baseline) to follow-up 1 (one week post doing session) to follow-up 2 (one month post dosing session)]
• Mood [Срок оценки: from baseline to one week and one month post-dosing]
• Well-being [Срок оценки: from baseline to one week and one month post-dosing]
• Anxiety [Срок оценки: from baseline to one week and one month post-dosing]
• Cognitive Flexibility [Срок оценки: from baseline to one week and one month post-dosing]
• Spontaneous Thought [Срок оценки: from baseline to one week and one month post-dosing]
• Reinforcement Learning [Срок оценки: from baseline to one week and one month post-dosing]

Критерии участия

Критерии включения

• Individuals of all sexes, gender identities, and ethnicities
• Ages 18 to 65 years of age at the time of screening
• Ability to read/write in English
• Agree not to consume psychoactive drugs 24 hours before dosing sessions or consume psychedelics during duration of study participation

Критерии исключения

• Any notable abnormality on electrocardiogram or routine medical blood or urinalysis laboratory tests
• Current psychiatric diagnoses, such as: major depressive disorder, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive compulsive disorder, moderate to severe substance use disorders, eating disorders, personality disorders, post-traumatic stress disorder
• Lifetime or current psychiatric diagnoses of: psychosis, schizophrenia, bipolar disorder
• Family history: a first- or second degree relative with a history of schizophrenia or other psychotic disorders, bipolar I or II
• Medication: Any medication with the potential to interact with the investigational medicinal products, especially those with serotonergic mechanisms of actions like SSRIs, SNRIs or MAO-Inhibitors as well as other antipsychotics
• Currently pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study
• Current or recent (within 12 weeks) participation in a clinical trial involving medication administration
• Cognitive impairment (Folsetin Mini Mental State Exam score < 24)
• A disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
• Suffered a traumatic brain injury with one of the following symptoms Loss of consciousness >30min Alteration of consciousness/mental state >24h Post-traumatic amnesia >1 day Glasgow Coma Scale (best available score in first 24 hours) <13
• Any other circumstances that, in the opinion of the investigators, compromises participant safety

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• University of Calgary — Calgary

Идентификаторы

NCT: NCT06768944 · REB24-1121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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