Cognitive ChangeNATMICRONCT05160220
Naturalistic Study of Microdosing With Psilocybin
A study testing Psilocybin in people with Cognitive Change and Creativity, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Creativity, Mood Change
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Jan 2021to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Instituto de Fisica de Buenos Aires (IFIBA)
Buenos Aires, 1428
About this study
Official title: Double-blind Placebo-controlled Naturalistic Study of Microdosing With Psilocybin: Effects on Brain Activity, Behavior, Cognition, Creativity, and Mental Health
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.
Read the 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.
- Conditions
- Cognitive Change, Creativity, Mood Change, Sleep
- Being tested
- Psilocybin, Placebo
- Keywords
- psilocybin, psychedelics, nootropics, microdosing, EEG, cognition, creativity, behavior, sleep
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin.
PlaceboDrug
0.5 g dried edible non-psychoactive mushroom material.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Psilocybin |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Attention
Measured performance in the attentional blink paradigm
Measured: 1 week
Inhibitory control
Measured using the go/no go experimental paradigm
Measured: 1 week
Conscious access
Measured using the backward masking paradigm
Measured: 1 week
Visual perception
Measured using the binocular rivalry paradigm
Measured: 1 week
Physical activity
Measured using wrist actigraphy using a smartwach
Measured: 1 week
Divergent thinking
Measured using the Alternative Uses Task (AUT)
Measured: 1 week
Attention
Measured using the hiearchical mismatch negativity paradigm combined with EEG
Measured: 1 week
Cognitive flexibility
Measured using the stroop task
Measured: 1 week
Convergent thinking
Measured using the Remote Associations Task (RAT)
Measured: 1 week
Convergent thinking
Measured using the Wallach-Kogan test (WK)
Measured: 1 week
Secondary outcomes (4)
Effect positive/negative affect and well-being
Measured using the Positive and Negative Affect Schedule (PANAS)
Measured: 1 week
Effects on anxiety
Measured using State Trait Anxiety Inventory (STAI)
Measured: 1 week
Effects on personality
Measured using the Big Five inventory (BFI)
Measured: 1 week
Concentration of psilocybin in the dried material
To be measured using high performance liquid chromatography
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start20 Jan 2021
- Primary completion30 Jun 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Enzo Tagliazucchi, National Council of Scientific and Technical Research, Argentina
- Investigators
- Enzo Tagliazucchi, PhD, Principal investigator, National Council of Scientific and Technical Research, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160220
- Sponsor's protocol ID
- 001
- Acronym
- NATMICRO
- Status last verified
- Dec 2021
- First submitted
- 5 May 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All raw data will be made available online through a data sharing webside (e.g. Zenodo) upon publication of the pre-pring containing the results of our study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo-controlled Naturalistic Study of Microdosing With Psilocybin: Effects on Brain Activity, Behavior, Cognition, Creativity, and Mental Health
- ClinicalTrials.gov ID
- NCT05160220
- Acronym / sponsor ID
- NATMICRO / 001
- Conditions
- Cognitive Change, Creativity, Mood Change, Sleep
- Keywords
- psilocybin, psychedelics, nootropics, microdosing, EEG, cognition, creativity, behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybe cubensis | Active comparator | Drug: Psilocybin0.5 g dried and powdered P. cubensis in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order. |
| Inactive placebo | Placebo comparator | Drug: PlaceboSame weight of inactive placebo in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Use of psychotropic medication during the study, including stimulants such as caffeine.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin. | Drug | Psilocybe cubensis |
| Placebo0.5 g dried edible non-psychoactive mushroom material. | Drug | Inactive placebo |
Primary outcome
Resting state oscillations measured with EEG
Time frame: 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
Time frame: 1 week
Measured performance in the attentional blink paradigm
Inhibitory control
Time frame: 1 week
Measured using the go/no go experimental paradigm
Conscious access
Time frame: 1 week
Measured using the backward masking paradigm
Visual perception
Time frame: 1 week
Measured using the binocular rivalry paradigm
Physical activity
Time frame: 1 week
Measured using wrist actigraphy using a smartwach
Divergent thinking
Time frame: 1 week
Measured using the Alternative Uses Task (AUT)
Attention
Time frame: 1 week
Measured using the hiearchical mismatch negativity paradigm combined with EEG
Cognitive flexibility
Time frame: 1 week
Measured using the stroop task
Convergent thinking
Time frame: 1 week
Measured using the Remote Associations Task (RAT)
Convergent thinking
Time frame: 1 week
Measured using the Wallach-Kogan test (WK)
4 secondary outcomes
Effect positive/negative affect and well-being
Time frame: 1 week
Effects on anxiety
Time frame: 1 week
Effects on personality
Time frame: 1 week
Concentration of psilocybin in the dried material
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: Yes. All raw data will be made available online through a data sharing webside (e.g. Zenodo) upon publication of the pre-pring containing the results of our study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enzo Tagliazucchi, PhD principal investigator
National Council of Scientific and Technical Research, Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psilocybin in people with Cognitive Change and Creativity, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting state oscillations measured with EEG (time frame: 1 week). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.