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

This non-randomized trial (n=100) investigates the psychological, cognitive, and physiological effects of a single session of psychedelic drug exposure with either psilocybin or MDMA in a group setting. The study is conducted by Monarch Mental Health Group, in collaboration with Australian National University and Mind Medicine Australia.

Participants aged 21 to 70 must be healthy, trained in psychedelic-assisted psychotherapy, and willing to practice effective birth control. The trial involves either psilocybin or MDMA administered in capsule form during an 8-hour supervised session, with participants choosing their preferred substance. The primary outcome measures include psychological experience, cognitive function, and electroencephalography (EEG) data.

The study also explores changes in neural activity, tolerability, replication of pre-post differences in a crossover arm, and the impact on therapist competency. The trial, named ASSESS, began recruitment in September 2023 and is expected to conclude data collection in April 2026. The study is funded by Monarch Mental Health Group, Australian National University, and Mind Medicine Australia.

Topic Healthy Subjects
Compound MDMA Psilocybin
Country Australia
Visit trial
Status Recruiting
Results Published No
Start date 26 September 2023
End date 12 January 2026
Phase Phase II Phase III
Design Open
Type Interventional
Generation First
Participants 100
Sex All
Age 21- 70
Therapy Yes

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.

NCT Number ACTRN12622001535763

Sponsors & Collaborators

Mind Medicine Australia
Mind 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).

Data attribution

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