This interventional trial (n=100) aims to investigate the impact of single-session psychedelic drug exposure, using either psilocybin or MDMA, in a group setting.
Participants, healthy individuals trained in psychedelic-assisted psychotherapy aged between 21 and 70, will undergo a preparatory session before an 8-hour dosing session supervised by two therapists.
The study will explore changes in depression rating scale scores, personality traits, trust in others, EEG measures, cognitive function, and various psychological experiences before and after the drug exposure. Secondary objectives include assessing neural activity during substance exposure, evaluating tolerability, replicating pre-post differences in a smaller cross-over sample, and gauging the impact on self-assessed therapist competency.
The trial, conducted without masking, is funded by Monarch Mental Health Group, Australian National University, and Mind Medicine Australia, with Dr Neil Bailey as the principal investigator.
Recruitment began in September 2023 in New South Wales and Victoria, Australia. Data sharing, including EEG and self-report data, will be available three months after main results publication.
Trial Details
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Sponsors & Collaborators
Mind Medicine AustraliaMind Medicine Australia is a non-profit that provides a conference, training for psychedelic-assisted therapies, supports research, and does advocacy for psychedelics in Australia (and Asia-Pacific).