A new study published in the Journal of Psychopharmacology has found that psilocybin – a psychedelic drug isolated from magic mushrooms – can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously. The researchers also confirmed that psilocybin has the potential to treat a range of mental health conditions, including treatment-resistant depression (TRD) and post-traumatic stress disorders (PTSD).
A research team led by King’s College London and COMPASS Pathways enrolled 89 healthy participants with no recent history of psilocybin use, and offered 60 of them either a 10mg or 25mg dose of psilocybin in a controlled environment. The remaining 29 participants received a placebo, and all 89 were provided with one-to-one support from trained psychotherapists.
Participants were closely monitored for six to eight hours and then followed up for 12 weeks in order to be assessed for possible cognitive and behavioral changes in sustained attention, planning, memory, and emotional processing. During the study, no one withdrew due to adverse effects and no consistent trends suggested that either of the two psilocybin doses had any short- or long-term side effects.
“This study was an early part of our clinical development program for COMP360 psilocybin therapy,” explained Professor Guy Goodwin, the Chief Medical Officer at COMPASS Pathways. “It explored the safety and feasibility of simultaneous psilocybin administration, with 1:1 support, in healthy participants, and provided a strong foundation to which we have now added positive results from our phase IIb trial in 233 patients with TRD, and from our open-label study of patients taking SSRI antidepressants alongside psilocybin therapy. We are looking forward to finalizing plans for our phase III program, which we expect to begin in Q3 2022.”
According to lead author Dr. James Rucker, a psychiatrist and researcher at King’s College London, this rigorous study has demonstrated the feasibility and safety of administering doses of 10mg or 25mg of psilocybin to several persons at once, and showed a significant potential of these psychedelic drugs to be used as a treatment for debilitating mental health problems.
“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,” he concluded.