A clinical trial of psilocybin-assisted psychotherapy for treatment-resistant anorexia nervosa

Phase 1

• Conditions: Anorexia Nervosa; Mental Health - Eating disorders

• Registration Number: ACTRN12623000357651
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-06
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

•Female patients aged 21+ years
•Meet criteria for AN as per DSM-5 criteria
•BMI greater than or equal to 14kg/m2
• > 3 years of illness duration
•Current/ past treatments have not maintained remission
•Referral from care team (psychiatrist or GP and clinician)
•Agree to maintain contact with their care team
•Identified support person
•Agree to refrain from psychoactive drugs, nutritional or herbal supplements for at least 24 hours before each dose of psilocybin
•Agree to a washout serotonergic medications if currently prescribed
•Availability for the duration of the study
•Agree to have research team maintain contact with an identified next-of-kin or support person (i.e. close friend) for the duration of the study
•Capacity to consent
•Sufficiently competent in English and mental capacity to provide written informed consent.

Exclusion Criteria

•History of neurological conditions (e.g. epilepsy)
•Schizophrenia or other psychotic disorders/bipolar disorder
•First or second degree relative with psychotic disorder
•Severe dissociative disorders e.g.
•Diabetes
•Cardiovascular disease
•Uncorrected hypo- or hyperthyroidism
•Abnormal serum electrolytes
•Raised cardiac enzymes
•Abnormal QT interval prolongation at screening or history of this
•Hypertension
•Hepatic or renal failure (e.g., CrCl < 30ml/min)
•Drug or alcohol dependence in last 6 months
•Prior allergy, hypersensitivity or adverse reaction to psychedelic substances
•Emotionally unstable personality, or other psychiatric problem that may jeopardize therapeutic alliance or safety
•Currently an involuntary patient
•Patient being unsafe to manage on an outpatient basis
•History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
•History of laxative abuse in the last 3 months
•Unstable physical condition (e.g., weight loss > 2 kg in the prior month)
•Pregnancy (negative pregnancy tests mandatory at screening visits, baseline, and psilocybin dosing sessions) or Nursing
•If sexually active, participants who lack appropriate contraception
•Patients currently or previously (past 3 months) enrolled in another clinical trial of an investigational product
•No email/phone.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in core eating disorder psychopathology by the Eating Disorder Examination and the Eating Disorder Examination-Questionnaire (EDE/EDE-Q)[ It will be administered at baseline assessment, primary endpoint (6 weeks post-first dose), monthly follow-up to 6-months and a 12-month follow-up post-first dose. ];Effect of psilocybin-assisted psychotherapy on motivation to change. Measured by the Readiness and Motivation Questionnaire (RMQ). [ Administered at baseline assessment, primary endpoint (6 weeks post-first dose), monthly follow-up to 6-months and 12-month follow-up post-first dose. ]