Toward Embodied Healing: Feasibility of a... — Clinical Trial Details

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.

Participants

Ages

21 – 99

Sexes

female

BMI

Psychosis History

Excluded

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin-assisted psychotherapy

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details