Clinical TrialEating DisordersPsilocybinCompleted

Effects of Psilocybin in Anorexia Nervosa

Open-label, single-group Phase I pilot (n=22) testing up to four oral psilocybin sessions (initial 20 mg, titratable to 30 mg) in adults with chronic anorexia nervosa to assess safety and preliminary efficacy.

Target Enrollment
22 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This open-label pilot investigates safety and efficacy of psilocybin administered in a supportive setting with close follow-up in adults with chronic anorexia nervosa; primary aims are safety, reduction in anxiety and depression, and improved quality of life.

Participants may receive up to four moderate-to-high oral psilocybin sessions (first session 20 mg, subsequent sessions may increase by 5 mg to a maximum of 30 mg); outcomes include clinical measures of eating-disorder pathophysiology, mood, and safety assessments.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Up to four moderate-to-high oral psilocybin sessions with dose titration.

Interventions

  • Psilocybin20 - 30 mg
    via Oral• up to four sessions• 4 doses total

    First session 20 mg; subsequent sessions may increase by 5 mg increments to max 30 mg.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Currently meet criteria for AN restricting subtype by DSM-5 and have a history of AN for at least 3 years prior to screening.
  • At least one prior attempt at treatment.
  • Be otherwise medically stable as determined by personal interview, medical questionnaire, physical examination, ECG, and routine labs (CBC, CMP, urine pregnancy test, urine toxicology screen).
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration (caffeine excepted).

Exclusion Criteria

  • Women who are pregnant or nursing; women of childbearing potential and sexually active who are not using an effective means of birth control.
  • Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality, heart valve disease, or transient ischemic attack in the past year; resting heart rate <50 bpm unless cleared by a cardiologist.
  • Epilepsy with history of seizures.
  • Type 1 diabetes.
  • First-degree relative with schizophrenia spectrum or other psychotic disorders, or Bipolar I Disorder.
  • Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment22 participants
  • Timeline
    Start: 2019-08-26
    End: 2022-12-01
  • Compound
    Psilocybin
  • Topic
    Eating Disorders

Locations

Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States

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