Results from a new study have demonstrated that 10mg or 25mg doses of psilocybin have no long- or short-term detrimental effects in healthy individuals.
In an essential first step in demonstrating the safety and feasibility of psilocybin, a new study has shown the compound can be safely administered in 10mg or 25mg doses to up to six participants simultaneously.
The study is the first of its kind to investigate the simultaneous administration of psilocybin for use within controlled settings alongside talking therapy as a potential treatment for conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD).
The research, from the Institute of Psychiatry, Psychology, & Neuroscience (IoPPN) at King’s College London, carried out in partnership with UK company COMPASS Pathways, has been published in The Journal of Psychopharmacology.
National Institute for Health Research clinical scientist, Dr James Rucker, is the study’s lead author from IoPPN, and is honorary consultant psychiatrist at South London and Maudsley NHS Foundation Trust.
Rucker commented: “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 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.”
Early research indicates psilocybin therapy as potentially efficacious for the treatment of such conditions, however, so far, no trials have been undertaken at the scale needed for regulatory approval to make the therapy available.
CMO at COMPASS, professor Guy Goodwin, added: “This study was an early part of our clinical development programme for COMP360 psilocybin therapy.
“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 finalising plans for our phase III programme, which we expect to begin in Q3 2022.”
The investigators have since completed Phase II of the study, which has explored the efficacy and safety of psilocybin in people living with TRD and PTSD, and are currently analysing the data.
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