New research from Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London, in collaboration with COMPASS Pathways, has established that psilocybin can be safely administered in doses of 10 mg or 25mg up to to 6 participants at the same time.
The research, published in The Journal of Psychopharmacology, is a first essential step in the demonstration of the safety & feasibility of psilocybin – a psychedelic drug isolated from psilocybe mushroom, for use in controlled environments alongside speech therapy as a potential treatment for a range of mental health problems, including treatment-resistant depression (TRD) & PTSD.
Current treatment options for these conditions are ineffective or partially effective for many people, resulting in a significant unmet need. Early research indicated a potential for psilocybin therapy to treat these groups, but no studies have been conducted on the scale necessary for regulatory approval to make the therapy available.
The study is the first of its kind to fully investigate the simultaneous administration of psilocybin. 89 healthy participants without recent (less than a year) use of psilocybin were recruited. 60 people were randomly selected to receive a 10 mg or 25 mg dose of psilocybin in a controlled setting. In addition, all participants received individual support from trained psychotherapists. The remaining 29 participants act as a control group & received a placebo, including with psychological support.
Participants were closely monitored for 6-8 hours after receiving psilocybin & then followed for 12 weeks. During this time, they were evaluated for a number of possible changes, including sustained attention, memory, & planning, as well as their ability to process emotions.
National Institute for Health Research clinical researcher Dr James Rucker, lead author of the King’s IoPPN study & honorary consultant psychiatrist at South London & the Maudsley NHS Foundation Trust, said: “This rigorous study is an important first demonstration that simultaneous administration of psilocybin can be further explored.
If we think about how psilocybin therapy (if approved) can be delivered in the future, it is important to demonstrate the feasibility & safety of giving it more than one person at a time, so that we can think about how to increase the processing. This therapy shows promise for people living with serious mental health issues, such as treatment-resistant depression (TRD) & PTSD. They can be extremely disabled, painful & disruptive, but the current treatment options of these conditions are ineffective or partially effective for many people.
During the study, there were no cases of people withdrawing from the study due to an adverse event & no consistent trend suggesting that any of the doses of psilocybin had any adverse effects in the short term. or long term on participants.
Professor Guy Goodwin, Chief Medical Officer of COMPASS Pathways, said: “This study was the first part of our clinical development program for the therapy of psilocybin COMP360. It explored the safety & feasibility of concurrent administration of psilocybin, with 1: 1 support, in healthy participants, and provided a solid foundation to which we have now added the positive results of our study of phase IIb on 233 patients with TRD & from our open label study of patients taking SSRI antidepressants concurrently with psilocybin therapy. We look forward to finalizing plans for our Phase III program, which we expect to start in the third quarter of 2022.”
The researchers have since completed the Phase II study, which explored the efficacy & safety of psilocybin in people living with TRD & PTSD, and are analyzing the data.