Clinical TrialMicrodosingPsilocybinPlaceboCompleted

Naturalistic Study of Microdosing With Psilocybin (NATMICRO)

Placebo-controlled, double-blind randomized naturalistic microdosing study (n=34) testing two 0.5 g dried Psilocybe cubensis sessions versus matched placebo in healthy microdosing volunteers with EEG, cognitive, behavioural and self-report outcomes.

Target Enrollment
34 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

This naturalistic, double-blind, placebo-controlled study examines acute and short-term effects of low doses of psilocybin (0.5 g dried Psilocybe cubensis, ~0.8 mg psilocybin) taken in participants' usual environments.

Two dosing sessions (active vs placebo) are administered in randomized order one week apart; outcomes include resting-state EEG, evoked potentials, cognitive task performance, creativity measures, actigraphy-derived sleep and behavioural metrics, natural language analysis, and standardised self-report instruments.

Participants are intrinsically motivated microdosers and will follow the study protocol while wearing a smartwatch for continuous activity and sleep monitoring during each measurement week.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin microdose

experimental

0.5 g dried Psilocybe cubensis in gel capsules; two dosing sessions separated by one week; randomized order, double-blind.

Interventions

  • Psilocybin0.5 g
    via Oral• two sessions• 2 doses total

    ~0.8 mg psilocybin per 0.5 g dried mushroom material; administered in gel capsules in natural settings

Placebo

inactive

Matched 0.5 g dried edible non-psychoactive mushroom material in gel capsules; two sessions, randomized order.

Interventions

  • Placebo0.5 g
    via Oral• two sessions• 2 doses total

    Inactive dried edible mushroom material in gel capsules

Participants

Ages
21 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Men and women aged >21 years.
  • 2. Participants are planning to microdose using their own dried mushroom material and will adhere to the experimental protocol.
  • 3. No active psychiatric conditions requiring treatment with psychotropic medications.
  • 4. Able to provide informed consent.

Exclusion Criteria

  • Exclusion 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.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment34 participants
  • Timeline
    Start: 2021-01-20
    End: 2021-10-01
  • Compounds
    PsilocybinPlacebo
  • Topic
    Microdosing

Locations

Instituto de Fisica de Buenos Aires (IFIBA) — Buenos Aires, Argentina

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