Phase I psilocybin safety trial ATMA

This Phase I open-label trial (n=14) studied the safety of psilocybin when administered to healthy participants enrolled in a psychedelic-assisted therapy training program. Participants ingested 25 mg of psilocybin extract, and vital signs, including heart rate, blood pressure, temperature, and ECG, were monitored throughout the study.

Adverse events were recorded at 2 days, 7 days, and 8 weeks following the psilocybin session. The trial aimed to collect physiological data and adverse events to help develop clinical screening protocols for psilocybin-assisted therapy, as well as assess the subjective effects of psilocybin at a dose of 25 mg.

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. Over the course of the study, participants will engage in symptom assessments (vital signs including heart rate, blood pressure, temperature, and ECG will be monitored). Participants will also be required to complete self-assessments before and after treatment. The first visit to the ATMA clinic (Visit 1) will consist of a preparatory session where vital signs will be assessed and the nature of the experimental session (Visit 2) will be discussed. The preparatory session will last about 1 hour. The experimental session where psilocybin is ingested (Visit 2) will last 4-8 hours, in which 25 mg of psilocybin extract will be ingested. Trained facilitators will be available as resources/support for the duration of the psilocybin dosing session and vital signs will be monitored. 2 and 7 days after the experimental session, participants will be contacted by a study coordinator to 'check in on their well-being, as well as obtain the results of their self-assessments. Eight weeks after the experimental session, participants will be required to have a follow-up appointment with their physician for a final assessment of vital signs, and follow-up with the Primary Investigator for a final adverse event assessment, as well as to provide their final self-assessments. After this final appointment, involvement in the study will end.

NCT Number ISRCTN15259909

Data attribution

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