Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT05160220
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2021-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Naturalistic Study of Microdosing With Psilocybin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011562', 'term': 'Psilocybin'}], 'ancestors': [{'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting state oscillations measured with EEG', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'Attention', 'timeFrame': '1 week', 'description': 'Measured performance in the attentional blink paradigm'}, {'measure': 'Inhibitory control', 'timeFrame': '1 week', 'description': 'Measured using the go/no go experimental paradigm'}, {'measure': 'Conscious access', 'timeFrame': '1 week', 'description': 'Measured using the backward masking paradigm'}, {'measure': 'Visual perception', 'timeFrame': '1 week', 'description': 'Measured using the binocular rivalry paradigm'}, {'measure': 'Physical activity', 'timeFrame': '1 week', 'description': 'Measured using wrist actigraphy using a smartwach'}, {'measure': 'Divergent thinking', 'timeFrame': '1 week', 'description': 'Measured using the Alternative Uses Task (AUT)'}, {'measure': 'Attention', 'timeFrame': '1 week', 'description': 'Measured using the hiearchical mismatch negativity paradigm combined with EEG'}, {'measure': 'Cognitive flexibility', 'timeFrame': '1 week', 'description': 'Measured using the stroop task'}, {'measure': 'Convergent thinking', 'timeFrame': '1 week', 'description': 'Measured using the Remote Associations Task (RAT)'}, {'measure': 'Convergent thinking', 'timeFrame': '1 week', 'description': 'Measured using the Wallach-Kogan test (WK)'}], 'secondaryOutcomes': [{'measure': 'Effect positive/negative affect and well-being', 'timeFrame': '1 week', 'description': 'Measured using the Positive and Negative Affect Schedule (PANAS)'}, {'measure': 'Effects on anxiety', 'timeFrame': '1 week', 'description': 'Measured using State Trait Anxiety Inventory (STAI)'}, {'measure': 'Effects on personality', 'timeFrame': '1 week', 'description': 'Measured using the Big Five inventory (BFI)'}, {'measure': 'Concentration of psilocybin in the dried material', 'timeFrame': '1 week', 'description': 'To be measured using high performance liquid chromatography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psilocybin', 'psychedelics', 'nootropics', 'microdosing', 'EEG', 'cognition', 'creativity', 'behavior', 'sleep'], 'conditions': ['Cognitive Change', 'Creativity', 'Mood Change', 'Sleep']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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").\n\nThe 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.\n\nThis 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:\n\nTwo 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.\n\nEach 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.\n\nThe 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and woman with more than 21 years.\n2. Participans are planning to microdose using their own dried mushroom material and adhere to the experimental protocol.\n3. No active psychiatric conditions requiring treatment with psychotropic medications.\n4. Able to provide informed consent.\n\nExcusion Criteria:\n\n1. Use of psychotropic medication during the study, including stimulants such as caffeine.\n2. Prior adverse reactions to psychedelics according to the Challenging Experiences Questionnaire administered during initial screening.\n3. Pregnant women or women during lactation\n4. History of high or low blood pressure or other cardiovascular risks.'}, 'identificationModule': {'nctId': 'NCT05160220', 'acronym': 'NATMICRO', 'briefTitle': 'Naturalistic Study of Microdosing With Psilocybin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Council of Scientific and Technical Research, Argentina'}, 'officialTitle': 'Double-blind Placebo-controlled Naturalistic Study of Microdosing With Psilocybin: Effects on Brain Activity, Behavior, Cognition, Creativity, and Mental Health', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Psilocybe cubensis', 'description': '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.', 'interventionNames': ['Drug: Psilocybin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inactive placebo', 'description': 'Same weight of inactive placebo in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'description': '0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin.', 'armGroupLabels': ['Psilocybe cubensis']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.5 g dried edible non-psychoactive mushroom material.', 'armGroupLabels': ['Inactive placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1428', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Fisica de Buenos Aires (IFIBA)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Enzo Tagliazucchi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Council of Scientific and Technical Research, Argentina'}]}, 'ipdSharingStatementModule': {'url': 'https://zenodo.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication, indefinite.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Council of Scientific and Technical Research, Argentina', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Enzo Tagliazucchi', 'investigatorAffiliation': 'National Council of Scientific and Technical Research, Argentina'}}}}