A study of the psychological, cognitive and physiological effects of Psychedelic Medicines on healthy individuals (ASSESS)

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

The primary objective of this project is to investigate psychological, cognitive and physiological changes associated with a single session of psychedelic drug exposure with psilocybin or 3,4-methylenedioxymethamphetamine (MDMA) in a group setting. Specifically, the study aims to use measures of psychological experience, cognitive function and electroencephalography (EEG) before and after psychedelic exposure. Secondary aims are (1) to assess changes in neural activity during acute substance exposure, (2) to determine whether tolerability is similar to previous studies, (3) to determine whether any pre-post differences we detect with the primary sample are replicated in a smaller sample who enter into a cross-over arm, taking the substance they did not take in the first instance, and (4) whether exposure to psychedelic drugs impacts self-assessed therapist competency. As both psilocybin and MDMA are becoming more commonly used to treat psychiatric illnesses, this study is important to improve our understanding of the mechanisms of action of these drugs. In addition, this study will contribute to enhancing the delivery of psychedelic therapies by identifying whether psychedelic dosing in a group setting is associated with improved outcomes, and whether exposure to psychedelic medicines enhances clinical self-rated competency. As such, this study will have the potential to be highly beneficial in improving our understanding of these drugs, and how to apply them, as they transition towards broad scale implementation as therapies for psychiatric conditions.

NCT Number ACTRN12622001535763

Data attribution

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