Phase I psilocybin safety trial

This open-label, phase I trial (n=14) conducted by The Newly Institute in Canada aims to assess the safety of psilocybin (25mg) when administered to healthy participants enrolled in a psychedelic-assisted therapy training program. The study spanned from August 2021 to August 2022 and was retrospectively registered.

The primary focus was on documenting psilocybin safety in healthy participants aged 18-65, primarily licensed healthcare professionals. Participants enrolled in the ATMA 8-week psychedelic-assisted therapy training program received 25 mg of oral psilocybin, and the study involved evaluating physiological parameters such as blood pressure, heart rate, temperature, and ECG. Safety was monitored at baseline, during the psilocybin session, and at 8 weeks post-session, with adverse events recorded. Secondary outcomes included assessing mood and mystical experiences.

While the study has been completed, the results have yet to be published. ATMA Journey Centers Inc. funded the trial, and Jennifer Bennett is its main contact.

Trial Details

Psilocybin is a psychedelic drug and the active ingredient in “magic mushrooms". Psilocybin is currently being studied in clinical trials and has no current medical use in Canada. While a number of studies have shown that a dose of psilocybin may improve depression and anxiety in people with cancer, as well as improve the overall mental health of people suffering from post-traumatic stress disorder (PTSD), substance use disorders, and work-related stress, more baseline physiological data (i.e. heart rate, blood pressure, body temperature) is required from healthy individuals after consuming psilocybin to demonstrate it can be safely administered in a clinical setting. This study aims to assess physiological data and adverse events to help develop clinical screening protocols for psilocybin-assisted therapy. This study also aims to further assess the subjective effects of psilocybin at a dose of 25 mg.

NCT Number ISRCTN15259909

Data attribution

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