Naturalistic Study of Microdosing With Psilocybin

Not Applicable

Completed

• Conditions: Cognitive Change; Creativity; Mood Change; Sleep
• Interventions: Drug: Placebo; Drug: Psilocybin

• Registration Number: NCT05160220
• Lead Sponsor: National Council of Scientific and Technical Research, Argentina

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-05-05
• Primary Completion: 2021-06-30
• Study Completion: 2021-10-01
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-03
• Last Update Submitted: 2021-12-03
• Study First Posted: 2021-12-16
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inactive placebo	Placebo	Same weight of inactive placebo in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order.
Psilocybe cubensis	Psilocybin	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.

Primary Outcome Measures

Name	Time	Method
Resting state oscillations measured with EEG	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	1 week	Measured using the backward masking paradigm
Visual perception	1 week	Measured using the binocular rivalry paradigm
Attention	1 week	Measured using the hiearchical mismatch negativity paradigm combined with EEG
Inhibitory control	1 week	Measured using the go/no go experimental paradigm
Physical activity	1 week	Measured using wrist actigraphy using a smartwach
Divergent thinking	1 week	Measured using the Alternative Uses Task (AUT)
Cognitive flexibility	1 week	Measured using the stroop task
Convergent thinking	1 week	Measured using the Wallach-Kogan test (WK)

Secondary Outcome Measures

Name	Time	Method
Effect positive/negative affect and well-being	1 week	Measured using the Positive and Negative Affect Schedule (PANAS)
Effects on anxiety	1 week	Measured using State Trait Anxiety Inventory (STAI)
Effects on personality	1 week	Measured using the Big Five inventory (BFI)
Concentration of psilocybin in the dried material	1 week	To be measured using high performance liquid chromatography

Trial Locations

Locations (1)

Instituto de Fisica de Buenos Aires (IFIBA); 🇦🇷 Buenos Aires, Argentina