Clinical TrialEating DisordersPsilocybinCompleted

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Open-label, single-group pilot (n≈21) testing psilocybin-assisted psychotherapy with three dosing sessions (max 25 mg) in adults with chronic anorexia nervosa.

Target Enrollment
21 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

This pilot interventional study recruits adults with a primary DSM‑5 diagnosis of anorexia nervosa of at least three years’ duration who have not responded to standard treatments; participants receive psilocybin-assisted psychotherapy over three dosing sessions (titrated, maximum single dose 25 mg).

Assessment includes two MRI scans, up to five EEG recordings, psychological measures and interviews across eight study visits, with 12 months of follow-up to evaluate acceptability, efficacy and neural correlates.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Open-label single-group psilocybin-assisted psychotherapy with three dosing sessions (titrated).

Interventions

  • Psilocybin25 mg
    via Oral• three sessions• 3 doses total

    Doses titrated across sessions; maximum single dose 25 mg.

Participants

Ages
21 – 65
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Primary DSM-V diagnosis of Anorexia Nervosa
  • 2. Current diagnosis of Anorexia Nervosa, established by specialist eating disorder care team to have likely been present for >3 years
  • 3. Current or past treatments have not been successful to maintain remission from anorexia
  • 4. Be in the care of a GP and specialist eating disorder team in the UK
  • 5. Have a GP and specialist eating disorder team in the UK who can confirm diagnosis
  • 6. Sufficiently competent in English and mental capacity to provide written informed consent
  • 7. BMI ≥14kg/m2 and medically stable
  • 8. Capacity to consent
  • 9. Agree to have us maintain contact with an identified next-of-kin for the duration of the study
  • 10. Agree to have us maintain contact with GP and/or specialist eating disorder team as required, for the duration of the study

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Current or previously diagnosed psychotic disorder
  • 2. Immediate family member with a diagnosed psychotic disorder
  • 3. Unstable physical condition e.g., rapid weight loss > 2kg in the prior month
  • 4. Abnormal serum electrolytes, raised cardiac enzymes, hepatic or renal dysfunction
  • 5. MRI or EEG contraindications
  • 6. A history of laxative abuse in the last 3 months (more than twice a week for 3 months)
  • 7. History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
  • 8. Currently an involuntary patient
  • 9. 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
  • 10. Blood or needle phobia
  • 11. Positive pregnancy test at screening or during the study, or woman who are breastfeeding
  • 12. If sexually active, participants who lack appropriate contraceptive measures
  • 13. Drug or alcohol dependence within the last 6 months
  • 14. No email access
  • 15. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 470ms)
  • 16. Patients who are currently, or have recently (within 3 months) been enrolled in another CTIMP.

Study Details

  • Status
    Completed
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment21 participants
  • Timeline
    Start: 2021-05-01
    End: 2023-09-01
  • Compound
    Psilocybin
  • Topic
    Eating Disorders

Locations

Imperial College Hammersmith campus — London, United Kingdom

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