Clinical TrialNeuroimaging & Brain MeasuresPsilocybinPlaceboPlaceboPsilocybinCompleted

Precision Functional Brain Mapping in Psilocybin

Randomized, single-blind, crossover neuroimaging study (n=11) comparing single-dose psilocybin 25 mg vs methylphenidate 40 mg in healthy adults to map acute and 1-week effects on functional brain networks.

Target Enrollment
11 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

This study uses precision functional mapping (PFM) and extended resting-state and task fMRI to characterise acute and sustained effects of 5-HT2A receptor agonism on cortical and cortico-subcortical networks in healthy adults.

A randomized, controlled crossover design has participants receive either psilocybin 25 mg oral capsule or methylphenidate 40 mg at two separate drug imaging sessions with a two-week washout, plus baseline and between-session imaging visits (up to five imaging sessions total).

PFM approach includes extended fMRI acquisition, aggressive data cleaning, and individual-level functional connectivity analyses to map drug-induced circuit changes and inform future clinical studies.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin first

experimental

Participants receive 25 mg psilocybin at the first of two drug neuroimaging sessions; crossover to methylphenidate at second drug session.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Oral capsule

  • Placebo40 mg
    via Oral• single dose• 1 doses total

    Active comparator: methylphenidate 40 mg (named in notes)

Methylphenidate first

active comparator

Participants receive 40 mg methylphenidate at the first of two drug neuroimaging sessions; crossover to psilocybin at second drug session.

Interventions

  • Placebo40 mg
    via Oral• single dose• 1 doses total

    Active comparator: methylphenidate 40 mg (named in notes)

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Oral capsule

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. men and woman between 18 and 40 years of age;
  • 2. Have used a psychedelic substance within the previous 5 years but not within the last 6 months;
  • 3. No active psychiatric conditions requiring treatment with psychotropic medications (may be included if psychiatric condition is stable and participant is willing to discontinue medication for 1 month prior to participation with permission from their treating provider);
  • 4. Able to provide informed consent.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Presence of medical conditions that may confound results of imaging study or that are contraindications to psilocybin exposure (e.g. neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy);
  • 2. No prior exposure to classic psychedelics (psilocybin, LSD, ayahuasca, mescaline);
  • 3. Presence of psychiatric conditions that may confound interpretation of results or that are contraindications to psilocybin exposure (e.g. major mood disorder, current substance use disorder, personal or immediate family history (parents, siblings) of any schizophrenia spectrum disorders);
  • 4. Use of psychotropic medication during the study;
  • 5. Presence of contraindications to MRI scanning (implantable devices, bone hardware, IUD);
  • 6. Prior adverse reactions to psychedelics, based on the Challenging Experiences Questionnaire administered during initial screening.

Study Details

Locations

Washington University — St Louis, Missouri, United States

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