This Phase I trial (n=60) aims to investigate the impact of psilocybin (19mg) and guided meditation on brain connectivity (fMRI & EEG) in healthy adults.
The trial involves 60 healthy participants, aged between 18-55 years, who will undergo fMRI and EEG scans at two-time points: approximately 1 week before oral capsule administration of 19mg psilocybin (baseline) and on the day of psilocybin administration. Participants will be stratified by age and sex and selected based on inexperience with classic psychedelics.
After psilocybin ingestion, participants will undergo MRI scans accompanied by naturalistic visual stimuli, meditation, and music to examine contextual factors’ influence on brain connectivity. EEG scans will include rest, guided meditation, and participant-selected music. Additionally, half of the participants will receive meditation practice sessions weekly for 8 weeks.
The primary outcomes include changes in brain connectivity measured using fMRI and EEG. Secondary outcomes include changes in depression, anxiety, stress, quality of life, personality traits, political perspectives, nature-relatedness, and subjective effects of psilocybin experiences.
Recruitment for the trial has been completed, with the first participant enrolled on 10/01/2022 and the last participant enrolled on 19/12/2022. The trial is being conducted in Victoria, Australia, and is funded by the Turner Institute for Brain and Mental Health at Monash University and the Canadian Institute for Advanced Research.
The principal investigator for the trial is A/Prof Adeel Razi.
Trial Details
Trial Number
Sponsors & Collaborators
Monash UniversityThe Clinical Psychedelic Lab, established in 2020, within the Dept Psychiatry at Monash University is the first of its kind in Australia, leading the development and implementation of psychedelic therapies. The lab has played a central role in establishing the field of clinical psychedelic research in Australia.
Canadian Institutes of Health Research
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Papers
Psychedelics Align Brain Activity with ContextThis neuroimaging study (n=62) investigates how psilocybin (19mg) reorganises brain connectivity in different contexts using fMRI and EEG. Participants were scanned before and after ingestion during rest and naturalistic stimuli (meditation, music, and visual). Under psilocybin, brain activity in eyes-closed states became more similar to eyes-open states, with increased connectivity in associative regions and decreased connectivity in sensory areas. The findings suggest that psilocybin induces a state of "embeddedness," reducing distinctions between self and environment, which may underlie both its subjective and therapeutic effects.