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

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

Psilocybin is quickly becoming a promising treatment for mental illness and is being studied widely due to its profound consciousness-altering properties. We want to better understand (1) how the consciousness-altering properties of psilocybin affect the brain and, (2) how contextual factors, such as mindset and environmental setting can impact the psilocybin experience. Healthy adults ages between 18-55 years who are residing in Victoria, Australia are recruited. Eligible adults will be asked to attend our research facilities in Clayton on two occasions to undergo a Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG). On the second visit, participants will be administered a moderate dose of psilocybin before undergoing the MRI and EEG. Throughout the study, participants will also be asked to complete an interview and online questionnaires, where they will be asked about their health and wellbeing. All participants will also be asked to attend one or more sessions designed to prepare participants for the psilocybin experience in a research setting. The main aim of this study is to improve our understanding of the neural mechanisms of psilocybin by applying computational modelling to (structural, functional and diffusion) MRI and EEG data collected from healthy adults while they are experiencing the acute effects of psilocybin. We will also investigate the influence of contextual factors to enhance the comfort of participants, such as the use of music and meditation during administration and meditation training prior to administration of psilocybin.

NCT Number ACTRN12621001375842

Data attribution

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