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.

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

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Compound research: PsilocybinTopic research: Eating DisordersResearch in United States

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 Protocol, Arms & Participants

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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

Study Team

Sponsors & Collaborators

Investigators

  • RG
    Roland Griffiths

Locations

Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States

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