Cognitive Change, Creativity, Mood Change, Sleep
Conditions
Keywords
psilocybin, psychedelics, nootropics, microdosing, EEG, cognition, creativity, behavior, sleep
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.
Interventions
DRUGPsilocybin
0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin.
DRUGPlacebo
0.5 g dried edible non-psychoactive mushroom material.
Sponsors
National Council of Scientific and Technical Research, Argentina
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inhibitory control | 1 week | Measured using the go/no go experimental paradigm |
| Convergent thinking | 1 week | Measured using the Remote Associations Task (RAT) |
| Divergent thinking | 1 week | Measured using the Alternative Uses Task (AUT) |
| 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. |
| Attention | 1 week | Measured performance in the attentional blink paradigm |
| Cognitive flexibility | 1 week | Measured using the stroop task |
| Conscious access | 1 week | Measured using the backward masking paradigm |
| Visual perception | 1 week | Measured using the binocular rivalry paradigm |
| Physical activity | 1 week | Measured using wrist actigraphy using a smartwach |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Argentina
Outcome results
None listed