A recent phase 1, randomized, double-blind, placebo-controlled study conducted by the Institute of Psychiatry, Psychology, & Neuroscience (IoPPN) at King's College London, in partnership with COMPASS Pathways demonstrated safety and feasibility in the administration of 10mg and 25mg of psilocybin to up to six participants.
This largest randomized controlled trial of psilocybin isolate (extracted from Psilocybe mushrooms) to date is the first study of its kind assessing the safety of simultaneous administration of psilocybin to healthy participants. The goal of the study was to measure the short and long-term changes to cognitive functioning and emotional processing, as well as safety measured through cognitive functions and treatment-emergent adverse events (TEAE) monitoring in an effort to assess the safety and feasibility of psilocybin isolate for the treatment of various mental health conditions including treatment-resistant depression (TRD) and PTSD.
The researchers simultaneously administered psilocybin to 89 healthy participants with no recent psilocybin use. The participants were monitored for the initial 6-8 hours period followed by talk therapy and follow-up for 12 weeks where they were assessed for various changes including attention, memory, planning, and emotional processing.
There were no participants that withdrew from the study due to adverse events and in follow-up weeks, the researchers found no short or long-term adverse effects on the participants.
National Institute for Health Research Clinical Scientist Dr James Rucker who led the study said: "This rigorous study is an important first demonstration that the simultaneous administration of psilocybin can be explored further. If we think about how psilocybin therapy (if approved) may be delivered in the future, it's important to demonstrate the feasibility and the safety of giving it to more than one person at the same time, so we can think about how we scale up the treatment. This therapy has promise for people living with serious mental health problems, like treatment-resistant depression (TRD) and PTSD. They can be extremely disabling, distressing and disruptive, but current treatment options for these conditions are ineffective or partially effective for many people."
Phase 2 of this study has since been completed with results pending publishing. Phase 2 focused on assessing the efficacy of the treatment for TRD & PTSD.