Naturalistic Study of Microdosing With Psilocybin

Sleep Clinical Trial

— NATMICRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05160220
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Men and woman with more than 21 years.

2. Participans are planning to microdose using their own dried mushroom material and adhere to the experimental protocol.

3. No active psychiatric conditions requiring treatment with psychotropic medications.

4. Able to provide informed consent.

Excusion Criteria:

1. Use of psychotropic medication during the study, including stimulants such as caffeine.

2. Prior adverse reactions to psychedelics according to the Challenging Experiences Questionnaire administered during initial screening.

3. Pregnant women or women during lactation

4. History of high or low blood pressure or other cardiovascular risks.

Related Conditions & MeSH terms

• Cognitive Change
• Creativity
• Mood Change
• Sleep

Intervention

Drug:
• Psilocybin
0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin.
• Placebo
0.5 g dried edible non-psychoactive mushroom material.

Locations

Country	Name	City	State
Argentina	Instituto de Fisica de Buenos Aires (IFIBA)	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
National Council of Scientific and Technical Research, Argentina

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting state oscillations measured with EEG	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.	1 week
Primary	Attention	Measured performance in the attentional blink paradigm	1 week
Primary	Inhibitory control	Measured using the go/no go experimental paradigm	1 week
Primary	Conscious access	Measured using the backward masking paradigm	1 week
Primary	Visual perception	Measured using the binocular rivalry paradigm	1 week
Primary	Physical activity	Measured using wrist actigraphy using a smartwach	1 week
Primary	Divergent thinking	Measured using the Alternative Uses Task (AUT)	1 week
Primary	Attention	Measured using the hiearchical mismatch negativity paradigm combined with EEG	1 week
Primary	Cognitive flexibility	Measured using the stroop task	1 week
Primary	Convergent thinking	Measured using the Remote Associations Task (RAT)	1 week
Primary	Convergent thinking	Measured using the Wallach-Kogan test (WK)	1 week
Secondary	Effect positive/negative affect and well-being	Measured using the Positive and Negative Affect Schedule (PANAS)	1 week
Secondary	Effects on anxiety	Measured using State Trait Anxiety Inventory (STAI)	1 week
Secondary	Effects on personality	Measured using the Big Five inventory (BFI)	1 week
Secondary	Concentration of psilocybin in the dried material	To be measured using high performance liquid chromatography	1 week