The PSILOCD Study recruitment is now open! (Evaluating the effects of the 5-HT 2A agonist psilocybin on the neurocognitive and clinical correlates of compulsivity: a pharmacological-challenge feasibility study.)

Who is involved in the PSILOCD Study?

The PSILOCD study is a clinical research study taking place at the CNWL-Imperial Psychopharmacology and Psychedelic Research Clinic (CIPPRes clinic) at St Charles Hospital. It is being led by researchers from the Centres for Neuropsychopharmacology and Psychedelic Research at Imperial College London, in partnership with the Highly Specialised Service for Obsessive Compulsive Disorders (OCDs) at the Hertfordshire Partnership University NHS Foundation Trust and the Behavioural and Clinical Neuroscience Institute at the University of Cambridge.

What is the purpose of this study?

The main purpose of this study is to test the effects of psilocybin on the way we behave and think when we have a compulsion. Psilocybin is a ‘psychedelic’ substance, the active ingredient in so-called “magic mushrooms”. Everyone will receive psilocybin twice. The maximum dose that you could be given is 10mg, considered a small-moderate dose. This is a “single-blind” study, meaning that you will not be told exactly what dose you will be receiving each time.

There have been some preliminary reports and medical case studies showing that psilocybin is possibly capable of providing relief from OCD symptoms, lasting for a few days or weeks. These case studies have led some scientists to try and test this in a more formal scientific way. One such study was conducted by a research group at the University of Arizona, by Moreno and colleagues, who found that psilocybin was possibly beneficial in relieving OCD symptoms. However, as this study was small and inconclusive, we are doing a follow-up one to find out more.

Finally, we are also interested in learning more about the effect of psilocybin on brain plasticity, which could be involved in its therapeutic effect. To investigate this, we will collect electroencephalography(EEG) brain recordings and collect samples of your blood for genetic testing.

What will happen if I take part?

You will need to attend the CIPPRes clinic at St. Charles Hospital in London for your screening session, and, if you are eligible, your two psilocybin sessions. All other sessions will be conducted remotely: 12 virtual calls over ~8 weeks. Travel or travel expenses will be provided, but you will not receive compensation for taking part.

Visit 1 – In-person Screening (~4 hours)

At the first visit, we will talk to you more about the study, take your consent, ask you about your medical and psychiatric history, do a physical examination, urine drug screen, pregnancy test (if applicable), alcohol breath test, take blood samples and ask you to complete some questionnaires. At the end of this visit, you will be given the option of wearing a ring for the next 8 weeks (similar to a “Fitbit”) that will record some physiological data such as heart rate and sleep.

Other Visits:

• 3 “preparation” calls to help you feel ready for the psilocybin sessions: up to 1hr each.
• 7 “integration” calls: psychological debriefs about your psilocybin sessions (audio recorded): between 1 – 2hrs each.
• 2 “cognitive task” calls with the Cambridge team (simple computer-based tasks): 1 – 1.5hr
  each.
• 2 in-person psilocybin sessions, up to 10mg (small dose): full days.
  o Most of your remote calls will also involve quick standardised interviews with the study psychiatrist and completing some questionnaires.
  o All of your in-person visits will involve urine drug screens, pregnancy tests (if applicable), breathalysers, blood tests and electroencephalography recordings (non-invasive and safe recordings of your brain’s electrical signals while you are performing simple tasks).
  o We will always confirm that you are happy to continue with the study at the start of each visit, as you are always free to withdraw.

What are the possible risks and benefits of taking part?

Psilocybin is a safe drug. We have administered much higher doses to hundreds of healthy and clinical participants and have never had “serious adverse events” take place. Nevertheless, you will be briefed on potential risks. We can’t be sure that you will gain any personal benefit in terms of improved health, fitness or sense of well-being from taking part in this study, but we hope that the results from the study will improve our understanding of using psilocybin as a potential treatment of OCD and give us a better understanding of the disorder.

What should I do if I am interested in participating?

Please complete the questions in the online form to register your interest. These will be reviewed by the study clinicians, who will contact you via email to arrange a video call screening if they think you may be eligible. During this call, you will be asked further questions to explore your eligibility, be able to ask any questions you may have and be provided with a much more detailed explanation of the study.