Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Study Overview
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Brief Summary
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The primary aim of this study is to assess the acceptability and efficacy of treating anorexia nervosa with psilocybin. The secondary aim of this study is to use Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group.

Detailed Description
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Anorexia nervosa is the most fatal of all psychiatric conditions. With the current paucity of effective pharmacological and psychological treatments, and fewer than half of those diagnosed making a full recovery, there is a great need for new treatment avenues to be explored. For this study, we will recruit patients who have a primary diagnosis of anorexia nervosa as defined by DSM-V criteria, which has been established by their specialist ED team to have been present for at least 3 years, and who have found other forms of treatment ineffective. Over a period of 6 weeks, participants who are deemed eligible at screening will partake in 8 study visits, including three psilocybin dosing sessions with varying doses. The maximum dose of psilocybin a participant will receive in a single session is 25 mg. Across these 8 visits, there will also be 2 MRI scans, up to 5 EEG recordings and a range of psychological measures (questionnaires and interviews). There will be a follow-up period of 12 months following the final study visit.

Official Title
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Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary DSM-V diagnosis of Anorexia Nervosa Current diagnosis of Anorexia Nervosa, established by specialist eating disorder care team to have likely been present for >3 years Current or past treatments have not been successful to maintain remission from anorexia Be in the care of a GP and specialist eating disorder team in the UK Have a GP and specialist eating disorder team in the UK who can confirm diagnosis Sufficiently competent in English and mental capacity to provide written informed consent BMI ≥14kg/m2 and medically stable Capacity to consent Agree to have us maintain contact with an identified next-of-kin for the duration of the study Agree to have us maintain contact with GP and/or specialist eating disorder team as required, for the duration of the study Exclusion Criteria: Current or previously diagnosed psychotic disorder Immediate family member with a diagnosed psychotic disorder Unstable physical condition e.g., rapid weight loss > 2kg in the prior month Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction MRI or EEG contraindications A history of laxative abuse in the last 3 months (more than twice a week for 3 months) History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening Currently an involuntary patient Emotionally unstable personality, history of mania, or other psychiatric problem that the screening clinician feels may jeopardise the therapeutic alliance and/or safe exposure to psilocybin Blood or needle phobia Positive pregnancy test at screening or during the study, or woman who are breastfeeding If sexually active, participants who lack appropriate contraceptive measures Drug or alcohol dependence within the last 6 months No email access Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms) Patients who are currently, or have recently (within 3 months) been enrolled in another CTIMP.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Psilocybin | Drug: Psilocybin<br>* Psilocybin assisted psychotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readiness and Motivation Questionnaire (RMQ) | Increase in readiness and motivation to recover from baseline to primary endpoint, which will be related to long-term improvements in psychopathology. | Baseline - Primary endpoint (6 weeks) | 
| Eating Disorder Examination (EDE) | Decrease in eating disorder psychopathology. | Baseline - Primary endpoint (6 weeks) - 6 month follow-up. | 
| Eating Disorder Examination Questionnaire (EDE-Q) | Decrease in eating disorder psychopathology. | Baseline - Primary endpoint (6 weeks) - 6 month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Magnetic Resonance Imaging (fMRI) | Changes in blood oxygen level dependent (BOLD) signal during rest and disorder relevant tasks. | Baseline - Primary endpoint (6 weeks) |