The Safety And Tolerability Of Comp360 (Psilocybin) In Participants With Post-Traumatic Stress Disorder
Aims
The effects of PTSD can be extremely debilitating and current treatments aren’t always effective. Working with COMPASS Pathways as part of a multi-centre trial King’s researchers are investigating the safety and tolerability of psilocybin for people with PTSD. The study will begin at IoPPN and participants will receive a single 25mg dose of COMP360 psilocybin, given in conjunction with specialist psychological support. They will be followed up for 12 weeks and the study will primarily assess safety but also and changes in PTSD symptoms and quality of life.
Methods
This is a phase 2, open-label study investigating psilocybin therapy as a treatment for posttraumatic stress disorder. All participants enrolled in this trial will receive 25mg of psilocybin embedded within at least 6 sessions of talking therapy. There is also a choice to take part in the neuroimaging (brain scan) element of the trial.
Participating in the trial
If you wish to volunteer for this trial, please consider your decision carefully. There are strict inclusion and exclusion criteria the team cannot deviate from. You will be usually asked to attend the research facility on numerous occasions, without much flexibility for variation in dates. Clinical trials are not the same as receiving treatment from your doctor or therapist. We use placebos or variable doses in some of our trials. You may not get the treatment you want and the team is unable to change this, for any reason.
For one reason or another, most people who volunteer turn out not to be eligible for a clinical trial. It’s important to be realistic about the chances of inclusion and pursue other sources of help at the same time.
Effects of Psychedelics
Depending on the drug, psychedelic therapy lasts from about 2 to 8 hours. We only give people psychedelics in a dedicated hospital facility with support from doctors, nurses, psychotherapists and study coordinators. We don’t give people psychedelics to take home.
It isn’t possible to predict how psychedelics will affect an individual person. Clinical trials are an experiment. They are being done because we do not yet know if psychedelic therapy is a safe and effective form of treatment. Therefore, your participation in a trial comes with some risks. Your condition could improve, stay the same or it could worsen.Psychedelic therapy is not a ‘reset’ for your brain and it is not a ’quick fix’. Regardless of what happens, it’s important to have the right support around you if this happens. There are limits to the extent the study team can support you, particularly out of normal office hours.
Trials Design
Status |
No longer recruiting |
Participants |
Adults |
Clinical area |
Post-traumatic stress disorder |
Intervention |
Psilocybin therapy |
Recruitment period |
2022-2023 |
Contact |
COMP201@kcl.ac.uk |
Funder |
Compass Pathways |
Sponsor |
Compass Pathways |