Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05160220 |
Other study ID # |
001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 20, 2021 |
Est. completion date |
October 1, 2021 |
Study information
Verified date |
December 2021 |
Source |
National Council of Scientific and Technical Research, Argentina |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
The main outcome measures consist of resting state activity recorded with EEG, evoked
response potentials and performance during cognitive tasks, behavioral variables obtained
with actigraphy and automated sleep scoring, natural language analysis, and several measurs
self-reported via standarized questionnaires.
After completion, this study will provide direct evidence concerning the efficacy of
microdosing for cognitive enhancement under natural conditions, i.e. those most frequently
used by individuals who microdose, as well as provide information concerning the potential
underlying neurobiological mechanisms.