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 programme. Participants ingested 25 mg of psilocybin extract, and vital signs, including heart rate, blood pressure, temperature, and ECG, were monitored.
Details
Phase I open-label single-arm safety study of a single 25 mg oral psilocybin dose in healthy participants enrolled in an 8-week psychedelic-assisted therapy training programme (n=14).
Safety assessments included blood pressure, heart rate, temperature and ECG during the session (hourly or as needed) and adverse events recorded at 2 days, 7 days and 8 weeks; mood and mystical experience were measured via QIDS-SR16 and MEQ-30.
Individual participant data are available in a public repository (figshare DOI https://doi.org/10.6084/m9.figshare.22329433.v1).