A psychedelic chemical found in magic mushrooms is safe to give to people in small doses, early research suggests.
The findings from King’s College London are based on a trial which gave 60 people psilocybin in either a 10 or 25 milligram dose.
It is the first study of its kind to test out the safety profile of the drug and found it to be well tolerated, opening the door for it to be used as a treatment for a range of mental health conditions, including some forms of depression and PTSD.
Previous research has indicated magic mushrooms, and specifically psilocybin, are a promising treatment but no human trials have been conducted until now.
The phase one randomised trial saw participants receive a small dose, a big dose, or a placebo in a controlled setting and they were then carefully observed for up to eight hours.
After the treatment, the patients received one-to-one support from trained psychotherapists and were followed up for 12 weeks.
During this time, they were assessed to track the number of possible changes, including sustained attention, memory, planning, as well as their ability to process emotions.
Dr James Rucker, a clinical scientist from the National Institute for Health Research, was the study’s lead author.
‘This therapy has promise’
He 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.”
Dr Rucker, who is also an honorary consultant psychiatrist at South London and Maudsley NHS Foundation Trust added: “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.”
No one withdrew from the study and there were no suggestions that either of the psilocybin doses had any short or long-term negative effects on the participants.
Professor Guy Goodwin, the chief medical officer at COMPASS Pathways, which ran the research, said: “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 one to one 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 three programme, which we expect to begin in Q3 2022.”