Clinical TrialEating DisordersPsilocybinNot yet recruiting

Toward Embodied Healing: Feasibility of a Psilocybin-Assisted Psychotherapy for Partially Recovered Anorexia Nervosa and Persistent Body Image Disturbance. A Manualised, Three-Dose, Open-Label Case Study

Open-label, single-group Phase I feasibility study (n=10) of psilocybin-assisted psychotherapy (one 5 mg then two 25 mg oral doses) for body image disturbance in women with prior anorexia nervosa.

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

Detailed Description

Participants receive manualised body image–focused psychotherapy: four 90-minute preparatory sessions, three supervised dosing sessions (5 mg at week 5; 25 mg at week 6; 25 mg at week 10), and seven integration sessions across weeks 5–16.

Feasibility and safety outcomes include audit of enrolment, session attendance and withdrawal logs; clinical assessments of body image disturbance and regular follow-up assessments through week 40 post-enrolment.

Study Protocol

Preparation

4 sessions
90 min each

Dosing

3 sessions

Integration

7 sessions
90 min each

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin-assisted psychotherapy

experimental

Manualised body image-specific preparatory, three oral-dose psilocybin sessions, and multiple integration sessions; open-label single-group feasibility study.

Interventions

  • Psilocybin5 - 25 mg
    via Oral• single dose per session• 3 doses total

    Dosing schedule: 1×5 mg (week 5), 1×25 mg (week 6), 1×25 mg (week 10); tablets; supervised dosing.

Participants

Ages
21 – 99
Sexes
female

Inclusion Criteria

  • Adults aged 21+
  • Female (assigned female at birth and currently identify as female gender).
  • Previously met criteria for anorexia nervosa (DSM-5) with BMI <18.5 at time of diagnosis.
  • Current BMI ≥18.5 kg/m2 sustained for minimum six months.
  • Medically stable as confirmed by care team (criteria: systolic BP ≥90; HR >50 and <100; no significant postural tachycardia or hypotension; normal ECG; normal electrolytes).
  • Body image disturbance as determined by a score of 3 on either the weight concern or shape concern subscale (or both) of the EDE-Q.
  • At least one previous treatment for eating disorder.
  • Current/past treatments have not led to remission from body image disturbance.
  • Minimum duration of BID six months.
  • Under the care of a psychiatrist, psychologist, physician or GP.
  • Identified caregiver/support person who agrees to participate and remain available for duration of study; participant consents to research team maintaining contact with nominated support person.
  • Capacity to provide consent (sufficient English proficiency).
  • Participants who can agree to a safely tapered and washed-off serotonergic medication prior to baseline assessment (as confirmed by treating medical doctor).
  • Agree to refrain from psychoactive drugs, nutritional or herbal supplements, and alcohol for minimum 48 hours prior to each psilocybin dose.
  • Can commit availability for duration of study.
  • Agree to have dosing sessions video-recorded for treatment fidelity and clinical supervision within the study team.
  • Able to swallow tablets.

Exclusion Criteria

  • General medical exclusions:
  • History of neurological conditions (e.g., epilepsy, other seizures) or any disorder with known CNS involvement; major CNS disease.
  • Diabetes.
  • Cardiovascular disease.
  • Uncorrected hypo- or hyperthyroidism.
  • Abnormal serum electrolytes; raised cardiac enzymes; abnormal QT interval prolongation at screening or prior history.
  • Hepatic dysfunction (GGT >3×ULN; AST or ALT >3×ULN; total bilirubin >3.0 mg/dL).
  • Conditions increasing risk for hypercalcaemia, Cushing's, hypoglycaemia, SIADH, or carcinoid syndrome.
  • Uncontrolled hypertension (systolic >140 or diastolic >90), angina, clinically significant ECG abnormality, recent TIA/stroke, peripheral or pulmonary vascular disease.
  • Renal insufficiency (creatinine clearance <40 mL/min).
  • Weight <40 kg.
  • Pregnant, nursing, trying to conceive, or become pregnant during study; inability/unwillingness to use contraception if sexually active.
  • Self-induced vomiting >3 episodes/week; purging >3 episodes/week; laxative abuse in past 3 months; recent rapid weight loss (>4 kg in past month or >2 kg during study).
  • Use of contraindicated medications (SSRIs, SNRIs, MAOIs) without willingness/ability to taper as appropriate; current use of potent metabolic inducers or inhibitors (listed in protocol).
  • Requirement to receive certain low therapeutic-index drugs within 12 hours after psilocybin (listed in protocol).
  • Psychiatric exclusions:
  • Current or past history of mania or psychosis (schizophrenia, psychotic disorders), bipolar I/II, or mania per DSM-5.
  • First-degree relative with diagnosed schizophrenia, psychotic disorder, bipolar I/II disorder or mania.
  • Current or past 12-month DSM-5 alcohol or drug dependence (excluding caffeine and nicotine).
  • Current DSM-5 dissociative disorder, or any psychiatric condition (including personality disorders) judged incompatible with therapeutic rapport or safe psilocybin exposure.
  • Lifetime history of serious suicide attempts or severe self-harm requiring hospitalisation; or current suicidal ideation with intent (screened with Columbia Suicide Severity Rating Scale as needed).
  • Unprocessed trauma as determined by ACE, PCL-5 and Life Events Checklist in consultation with staff.
  • Other exclusions:
  • Participation in another investigational product trial.
  • Prior allergy, hypersensitivity or adverse reaction to psychedelic substances.
  • Lack of consistent access to email and/or mobile phone for study duration.
  • Past 12-month use of any hallucinogen/psychedelic.
  • Use of illicit/extra-medical drugs or alcohol within 2 days prior to dosing (verified by urine drug test).
  • Personal or situational factors likely to interfere with participation (e.g., lack of social support, unstable housing, ongoing domestic violence).

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2024-04-01
    End: 2025-11-30
  • Compound
    Psilocybin
  • Topic
    Eating Disorders

Locations

Unknown facility — Australia

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