Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 20

Inclusion Criteria

•DSM-V diagnosis of Anorexia Nervosa
•>3 years of illness diagnosis
•Current or past treatments have not been successful to maintain remission
•21-65 years old
•Female
•Be in the care of a specialist eating disorder team in the UK
•Have a GP and/or specialist eating disorder team in the UK who can confirm diagnosis
•Sufficiently competent in English and mental capacity to provide written informed consent
•BMI >15kg/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 their specialist eating disorder team/care team as required for the duration of the study

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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
•Medical condition that is unsuitable for the EEG components of the study (e.g., epilepsy, severe migraine)
•Other physical conditions that are unsuitable for the psychedelic component of the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g., CrCl < 30ml/min etc)
•MRI contraindications
•Have a history of laxative abuse in the last 3 months (defined as laxative use 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
•Significant history of mania (determined by study psychiatrist and medical records)
•Emotionally unstable personality, or other psychiatric problem that the screening clinician feels may jeopardize 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 6 months) been enrolled in another CTIMP.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of the study is to assess the efficacy and feasibility of psilocybin in the treatment of Anorexia Nervosa. ;Secondary Objective: As a secondary aim, we wish to use Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) to examine the neuronal underpinnings of treatment with psilocybin in this patient group. ;Primary end point(s): Eating Disorder Examination interview and questionnaire<br>Readiness and Motivation Questionnaire ;Timepoint(s) of evaluation of this end point: The EDE will be measured at baseline and at the primary endpoint (6 weeks later). It will then be assessed 6 months after the final study visit. <br>The EDE-Q and RMQ will be assessed at baseline and every 2 weeks until primary endpoint. They will then be assessed monthly for 6 months after the final study visit, and again at 12 months post the final study visit.

Secondary Outcome Measures

Name	Time	Method

Related Trials