Clinical TrialNeuroimaging & Brain MeasuresPsilocybinPsilocybinActive not recruiting

Investigating the impact of Psilocybin and guided meditation on brain connectivity in healthy adults

Phase I interventional study (n=60) testing a single oral psilocybin 19 mg dose with vs without an 8‑week guided meditation programme to assess effects on brain connectivity (fMRI & EEG) in healthy adults.

Target Enrollment
60 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Sixty healthy volunteers undergo baseline and dosing‑day fMRI (≈60 min) and EEG (≈90 min) with naturalistic visual stimuli, music and guided open‑awareness meditation to measure changes in brain directed connectivity.

Half the participants receive 8 weekly 60‑minute meditation training (mindfulness, focused attention, open awareness, self‑compassion) with daily practice; adherence measured by FFMQ, MAQ, MEDI, EQ, SCS and weekly reflection questionnaires.

Primary outcomes are changes in effective (directed) brain connectivity measured across subjects and between groups using resting‑state fMRI and EEG at baseline and on the day of dosing.

Study Protocol

Preparation

8 sessions
60 min each

Dosing

1 sessions
225 min each

Integration

sessions

Therapeutic Protocol

mindfulness

Study Arms & Interventions

Psilocybin + meditation

experimental

Single oral psilocybin 19 mg with 8-week guided meditation training for half the participants and meditation during scans.

Interventions

  • Psilocybin19 mg
    via Oral• single dose• 1 doses total

    Paired with pre-study 8×60 min weekly meditation training for participants randomised to meditation arm; meditation during scans.

Psilocybin only

active comparator

Single oral psilocybin 19 mg without guided 12-week meditation practice (open-label comparator).

Interventions

  • Psilocybin19 mg
    via Oral• single dose• 1 doses total

    Open-label comparator arm receiving psilocybin capsule without meditation training.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Healthy adults aged 18–55 years.
  • No MRI contraindications.
  • Willing to abstain from illicit or extra‑medical drug and alcohol use for at least 2 days prior to dosing.
  • Able to swallow capsules.
  • Proficient in English sufficient for consent and questionnaires.
  • Limited previous exposure to classic psychedelics and meditation practices.

Exclusion Criteria

  • Current or previous DSM diagnosis of psychiatric disorder as determined by SCID.
  • Alcohol or drug dependence within last 5 years (excluding caffeine and nicotine).
  • Immediate family member with a diagnosed psychotic disorder (schizophrenia spectrum or bipolar I/II).
  • History of suicide attempts.
  • Use of any hallucinogen or psychedelic within past 6 months.
  • Taking contraindicated medications (SSRIs, SNRIs, MAOIs) at recruitment.
  • Use of potent metabolic inducers or inhibitors as specified (e.g., rifampin, carbamazepine, nevirapine, HIV protease inhibitors, itraconazole, erythromycin, clarithromycin, St John's Wort).
  • Known conditions increasing risk for hypercalcaemia, Cushing's, hypoglycaemia, SIADH, or carcinoid syndrome.
  • Medical requirement to receive certain low therapeutic index drugs within 12 hours after psilocybin (eg ergot alkaloids, pimozide, fentanyl).
  • Epilepsy or prior seizures; hepatic dysfunction; renal insufficiency (creatinine clearance <40 mL/min).
  • Body weight <48 kg.
  • Taking long‑acting opioid pain medications unless last dose ≥6 hours before dosing.
  • Uncontrolled cardiovascular disease (systolic >140 or diastolic >90), angina, clinically significant ECG abnormality, recent TIA/stroke, peripheral/pulmonary vascular disease.
  • Medically significant condition rendering unsuitability for the study.
  • Current participation in another investigational trial.
  • Positive pregnancy test or pregnancy/planning to become pregnant.
  • Unable to give adequate informed consent.
  • Allergy to gelatine or lactose.

Study Details

Locations

Unknown facility — Australia

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