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临床试验/NCT05160220
NCT05160220已完成不适用

Double-blind Placebo-controlled Naturalistic Study of Microdosing With Psilocybin: Effects on Brain Activity, Behavior, Cognition, Creativity, and Mental Health

National Council of Scientific and Technical Research, Argentina1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年1月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Resting state oscillations measured with EEG

研究概览

简要总结

This study seeks to understand the neural, cognitive and behavioral effects of low doses of psilocybin administered in the form of dried mushroom material (0.5 g of Psilocybe cubensis) consumed in natural settings following a placebo-controlled double-blind experimental design.

详细描述

Sub-threshold doses of serotonergic psychedelics are frequently consumed as cognitive enhancers, and due to their purported positive effects on mood, energy and creativity ("microdosing").

The acute and short-term effects of psilocybin (the psychoactive compound of Psilocybe cubensis mushrooms) on several variables will be investigated, comprising spontaneous and evoked electrophysiological brain activity, perception and cognitive function (cognitive flexibility, attention, inhibitory control, conscious access, visual perception), creativity (problem solving, divergent and convergent thinking), behavior (actigraphy and sleep patterns, natural language production) and several domains related to well-being and mental health of the participants.

This study is simultaneously naturalistic (i.e. recruited subjects are intrinsically motivated to microdose, as they have decided to embark in a microdosing protocol) and controlled by expectations, following a double-blind placebo-controlled design. Participants will microdose according to the following schedule:

Two sessions (0.5 g dried Psilocybin mushrooms vs. dried edible mushroom material without psychoactive effects as a placebo condition) will be conducted. A third party will be in charge of generating their active dose and placebo capsules, and they will also implement a blinding procedure.

Each session will span one week of measurements. Subjects will be given a smartwatch to monitor activity and sleeping patterns at the beginning of the week. At days 3 and 5, subjects will take capsules with active mushroom material or placebo, and then several variables will be recorded. Experiments will be conducted in a setting that is natural and comfortable for the participants, e.g. their homes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and woman with more than 21 years.
  • Participans are planning to microdose using their own dried mushroom material and adhere to the experimental protocol.
  • No active psychiatric conditions requiring treatment with psychotropic medications.
  • Able to provide informed consent.
  • Excusion Criteria:
  • Use of psychotropic medication during the study, including stimulants such as caffeine.
  • Prior adverse reactions to psychedelics according to the Challenging Experiences Questionnaire administered during initial screening.
  • Pregnant women or women during lactation
  • History of high or low blood pressure or other cardiovascular risks.

排除标准

  • 未提供

研究组 & 干预措施

Psilocybe cubensis

Active Comparator

0.5 g dried and powdered P. cubensis in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order.

干预措施: Psilocybin (Drug)

Inactive placebo

Placebo Comparator

Same weight of inactive placebo in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order.

干预措施: Placebo (Drug)

结局指标

主要结局

Resting state oscillations measured with EEG

时间窗: 1 week

Our goal is to study changes in spectral content before and during the acute effects with the purpose of comparing changes with those observed under higher doses of psilocybin.

Conscious access

时间窗: 1 week

Measured using the backward masking paradigm

Visual perception

时间窗: 1 week

Measured using the binocular rivalry paradigm

Attention

时间窗: 1 week

Measured using the hiearchical mismatch negativity paradigm combined with EEG

Inhibitory control

时间窗: 1 week

Measured using the go/no go experimental paradigm

Physical activity

时间窗: 1 week

Measured using wrist actigraphy using a smartwach

Divergent thinking

时间窗: 1 week

Measured using the Alternative Uses Task (AUT)

Cognitive flexibility

时间窗: 1 week

Measured using the stroop task

Convergent thinking

时间窗: 1 week

Measured using the Wallach-Kogan test (WK)

次要结局

  • Effect positive/negative affect and well-being(1 week)
  • Effects on anxiety(1 week)
  • Effects on personality(1 week)
  • Concentration of psilocybin in the dried material(1 week)

研究者

发起方
National Council of Scientific and Technical Research, Argentina
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Enzo Tagliazucchi

Principal Investigator

National Council of Scientific and Technical Research, Argentina

研究点 (1)

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