New research from the Institute of Psychiatry, Psychology, & Neuroscience (IoPPN) at King’s College London, in partnership with COMPASS Pathways, has established that psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.
The research, published in The Journal of Psychopharmacology, is an essential first step in demonstrating the safety and feasibility of psilocybin – a psychedelic drug isolated from the Psilocybe mushroom – for use within controlled settings alongside talking therapy as a potential treatment for a range of mental health conditions, including treatment-resistant depression (TRD) and PTSD.
Many patients find that the available treatments for these illnesses are ineffective or just partly successful, leaving a sizable unmet demand. Psilocybin therapy may be able to treat these individuals, according to preliminary studies, but no large-scale clinical trials have been conducted to get regulatory permission and make the therapy widely accessible.
The trial is the first of its kind to thoroughly investigate the simultaneous administration of psilocybin. 89 healthy participants with no recent (within 1 year) use of psilocybin were recruited. 60 individuals were randomly picked to receive either a 10mg or 25mg dose of psilocybin in a controlled environment. In addition, all participants were provided with one-to-one support from trained psychotherapists. The remaining 29 participants acted as the control group and received a placebo, also with psychological support.
Participants were closely monitored for six to eight hours following the administration of psilocybin and then followed up for 12 weeks. During this time, they were assessed for a number of possible changes, including sustained attention, memory, and planning, as well as their ability to process emotions.
National Institute for Health Research Clinical Scientist Dr. James Rucker, the study’s lead author from King’s IoPPN and honorary consultant psychiatrist at South London and Maudsley NHS Foundation Trust 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.”
No one withdrew from the trial at any point due to an adverse event, and there were no persistent patterns that may have indicated that either of the psilocybin dosages had any negative impact on participants throughout the duration of the study, either in the short or long term.
Professor Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: “This study was an early part of our clinical development program 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 finalizing plans for our phase III program, 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 analyzing the data.
Reference: “The effects of psilocybin on cognitive and emotional functions in healthy participants: results from a phase 1, randomised, placebo-controlled trial involving simultaneous psilocybin administration and preparation” by James J Rucker, Lindsey Marwood, Riikka-Liisa J Ajantaival, Catherine Bird, Hans Eriksson, John Harrison, Molly Lennard-Jones, Sunil Mistry, Francesco Saldarini, Susan Stansfield, Sara J Tai, Sam Williams, Neil Weston, Ekaterina Malievskaia and Allan H Young, 4 January 2022, Journal of Psychopharmacology.
So that is the next drug to become a treatment modality and therefore legal? I spent a good many years making my brain work exactly like I want it to work. I am very happy I did so. I don’t drink, smoke anything, nor desire to alter my reality. My reality is what I made it. Not what I smoked or drank or injected. Those things are costly and they don’t last. And if you had any idea of where I started in life you would be amazed. Trust me, hard work can be a pleasure when you know what you are doing. Escapism always lets you down.
The English live on a different globe and need to spend money on research that has already been done. Canadians are already applying treatment. See link.
Sorry Bonnie Davis. It really sounds like you’ve never experienced severe depression. It is a medical neurological condition that you can’t just think your way happy. If you tell loved ones to do that, please don’t it can be dangerous. Depression and Anxiety can be crippling and the person will only go further down as they will feel guilt on top of what they are experiencing.
If used in a proper setting with a therapist to guide you and talk therapy it opens your mind to deal with under lying issues. Research also shows that just a few sessions of it can stop symptoms for up to five years!!! No pills for FIVE YEARS sounds wonderful. Also shows that mushrooms are not addictive or dangerous especially if used in the right setting. Please research before you tell people how they should act please and thank you from the MH community.
Yes, it’s easy to say to people to snap out of things I have debilitating fibromyalgia, I’m tired of filling my body with over-the-counter NSAID, and acetaminophen, now I have liver problems. We need something to change a better drug. Maybe if he pain is relieved we can start feeling better to live a more proficient life. So many describe that their life is over from pain from fibro and chronic fatigue. I believe maybe the brain needs something to reset. Over time the brain gets stuck and needs a boost.