Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
34 participants
INTERVENTIONAL
2021-01-20
2021-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Psilocybe cubensis
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.
Psilocybin
0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin.
Inactive placebo
Same weight of inactive placebo in gel capsules, dosing on two separate days, separated by one week from the placebo, randomized order.
Placebo
0.5 g dried edible non-psychoactive mushroom material.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Psilocybin
0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin.
Placebo
0.5 g dried edible non-psychoactive mushroom material.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
21 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Council of Scientific and Technical Research, Argentina
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Enzo Tagliazucchi
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Enzo Tagliazucchi, PhD
Role: PRINCIPAL_INVESTIGATOR
National Council of Scientific and Technical Research, Argentina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto de Fisica de Buenos Aires (IFIBA)
Buenos Aires, , Argentina
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
001
Identifier Type: -
Identifier Source: org_study_id