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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Jessica
Barbut Siva
j.barbut-siva21@imperial.ac.uk
Sorcha
O'Connor
s.oconnor22@imperial.ac.uk
Prof
David
Nutt
d.nutt@imperial.ac.uk
Joseph
Peill
joseph.peill18@imperial.ac.uk
Mr
David
Erritzoe
d.erritzoe@imperial.ac.uk
Neurotic, stress-related and somatoform disorders
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Case studies and small clinical trials in the literature have shed light on the possibility of a novel tool to investigate OCD. The potential for an enduring effect of psilocybin, independent of its hallucinogenic effect, is particularly interesting and may reflect its central actions on a specific serotonin receptor in the brain (5-HT2A). We intend to test the hypotheses that psilocybin exerts an enduring effect on OCD symptoms by activating the 5-HT2A receptor mechanisms in the relevant brain areas to restore OCD-related behavioural deficits (as measured using tasks such as attentional set shift and reversal learning). Furthermore, we intend to explore how psilocybin alters the balance between goal directed behaviour and habit in OCD and if this is a result of the drug inducing neuronal plasticity (a term used to describe changes in neurone growth in the brain). Changes in neuronal plasticity will be assessed using electroencephalography (EEG) paradigms and blood biomarkers such as BDNF. To this end, we plan to do a single-blind pharmacological-challenge study on 20 patients with OCD (scoring at least 16 on the Yale-Brown Obsessive Compulsive Scale, Y-BOCS), where every patient receives 2 doses of psilocybin, maximum dose of 10mg (considered small-moderate). The study will involve 3 visits to the CNWL-Imperial Psychopharmacology and Psychedelic Research (CIPPRes) Clinic at St. Charles Hospital (Central and North West London NHS Trust, CNWL), including screening, as well as 12 remote calls involving preparation, psychological debriefing (psychedelic "integration") and data collection in the form of psychiatric interviews, questionnaires and cognitive tasks. This study has three primary outcomes, comparing scores at 1 week pre-psilocybin, 4 weeks after the first psilocybin dose and 4 weeks after the second: changes in the ID-ED set shifting task, changes in Y-BOCS scores and changes in the visual long-term potentiation (vLTP) EEG task.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Psychological & Behavioural;
You can take part if:
You may not be able to take part if:
• Current or past history of dependent (according to ICD10 criteria] substance use [not including nicotine and/or caffeine), Tourette’s syndrome, autism spectrum disorder, epilepsy, organic mental disorder, personality disorder apart from obsessive compulsive personality disorder. • Current or past history of psychosis or mania in themselves or a first degree relative • Had a previous severe adverse effect after psychedelic use • Specific medication for OCD other than SSRIs (e.g. antipsychotics, clomipramine and glutamatergic drugs taken ‘off-label’ for OCD) • History of psychosurgery • History of serious suicide attempts requiring hospitalisation • Current or chronic history of kidney or liver disease, and/or biochemistry renal/hepatic derangement of clinical significance, as determined by study clinician • In the opinion of the study team they are unlikely to comply with the study protocol and lifestyle restrictions that it imposes • Unstable physical illness • Significantly abnormal clinical test result • Significant cardiovascular disease • Patients presenting with arrhythmias or abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women) • Heavy smoker, or unable to complete the dosing and recovery part of the study visit without a smoking break • Those needing regular specified medication that might interact adversely with psilocybin e.g. 5HT1 agonists, mirtazapine, trazodone, analgesics that have serotonergic effects (tramadol), MAOI’s, antipsychotics with significant 5-HT2A receptor antagonist actions (risperidone, olanzapine and quetiapine) • Those judged to have inadequate understanding of English to participate in treatment or give informed consent; • Those unwilling to allow their GP or involved mental health practitioners to be informed of their participation, or allow study team access to Summary Care Record • Women of child-bearing age who are not using reliable contraceptive methods (see below) • Women of childbearing age who are unable to comply with or produce a positive pregnancy urine test.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Sorcha
O'Connor
s.oconnor22@imperial.ac.uk
Jessica
Barbut Siva
j.barbut-siva21@imperial.ac.uk
Joseph
Peill
joseph.peill18@imperial.ac.uk
Mr
David
Erritzoe
d.erritzoe@imperial.ac.uk
Prof
David
Nutt
d.nutt@imperial.ac.uk
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by ORCHARD .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 50985
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