Clinical TrialEating DisordersPsilocybinRecruiting

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

This open-label Phase I trial (n=10) evaluated the safety and efficacy of psilocybin for anorexia nervosa body image disturbance.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

This project is designed to assess the safety, feasibility and preliminary efficacy of psilocybin-assisted therapy (PAP) for body image disturbance (BID) in individuals with a history of anorexia nervosa. Participants will receive three doses of psilocybin alongside 14 sessions of therapy.

Female participants will be required to have a history of anorexia nervosa. These participants will be medically stable and in a range of weight restoration, with a minimum body mass index (BMI) of 18.5 and will have persistent BID. Participants will also be required to have had a minimum of one episode of evidence-based care for their eating disorder.

Participants will be expected to nominate an adult caregiver (“Support”, e.g. parent, partner, sibling, etc.) to participate in the study. Participant Supports will be required to commit to 3 non-dosing sessions.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Psilocybin

Participants

Inclusion Criteria

  • Adults aged 21+
  • Female (assigned female at birth and currently identify as female gender).
  • Have previously met criteria for anorexia nervosa, as per DSM-5 criteria (with BMI less than 18.5 at time of diagnosis)
  • Current BMI greater than or equal to 18.5kg/m2 sustained for minimum six months
  • Medically stable (as confirmed by care team (psychiatrist or GP). Medical stability is determined by:
  • - Systolic BP greater than or equal to 90
  • - HR greater than 50 and less than 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 subscale or shape concern subscale (or both subscales) 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 for BID for six months
  • Under the care of a psychiatrist, psychologist, physician or GP
  • Identified caregiver/support person who agrees to participate in study and can commit their availability for the duration of the study; and participant consents to have research team maintain contact with nominated support person for the duration of the study
  • Capacity to provide consent, as determined by sufficient proficiency in English (literacy and comprehension are sufficient to understand consent form and study questionnaires, as evaluated by study staff obtaining consent)
  • Participants who can agree to a safely tapered and washed-out serotonergic medications prior to baseline assessment (as confirmed by treating medical doctor)
  • Participants agree to refrain from psychoactive drugs, nutritional or herbal supplements, and alcohol use for minimum 48 hours prior to each dose of psilocybin.
  • Participants can commit their availability for the duration of the study
  • Participants who agree to have their drug dosing sessions recorded to video for treatment fidelity and clinical supervision within the study team.
  • Participants who can swallow tablets.

Exclusion Criteria

  • General medical exclusion criteria:
  • History of neurological conditions (e.g. epilepsy, other seizures) or any disorder with known CNS involvement, or other major CNS disease.
  • History of diabetes
  • History of cardiovascular disease
  • Uncorrected hypo- or hyperthyroidism
  • Abnormal serum electrolytes
  • Raised cardiac enzymes
  • Abnormal QT interval prolongation at screening or prior history
  • Hypertension
  • Hepatic dysfunction as indicated by the following values:
  • -- GGT > 3 x ULN (upper limit of norm)
  • -- AST > 3 x ULN
  • -- ALT > 3 x ULN
  • -- Tot Bili > 3.0 mg/dL
  • Known conditions putting participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome.
  • Cardiovascular conditions: uncontrolled hypertension (Systolic >140 and diastolic >90), angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), TIA in the last 6 months, stroke, or cerebrovascular disease, peripheral or pulmonary vascular disease (no active claudication). This could include patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440 ms for men and above 470 ms for women).
  • Renal insufficiency (creatinine clearance < 40 mL/min using the Cockcroft and Gault equation).
  • Participants who weigh less than 40kg
  • Participants who are pregnant or nursing or are trying to get pregnant, or become pregnant during the study
  • If sexually active, participants who cannot commit to appropriate contraception for duration of the study
  • Self-induced vomiting > 3 episodes per week
  • Purging > 3 episodes per week
  • History of laxative abuse in past 3 months
  • Current or previous rapid weight loss (>4kg weight loss in past month; >2kg weight loss during study)
  • Long-acting opioid pain medications (e.g., oxycodone sustained release, morphine sustained release -- which are usually taken at 12-hour intervals) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration.
  • Participants will be excluded if, at the time of recruitment, they are taking a contraindicated medication (SSRIs, SNRIs, MAOIs), and either 1) do not wish to be tapered off this medication, or 2) trial psychiatrists or the participant’s usual treatment team determine that tapering the participant off their current medication would be inappropriate for their health/safety.
  • Participants will be excluded if they are currently using any of the following potent metabolic inducers or inhibitors: Inducers - Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, paclitaxel, St John's Wort; Inhibitors - all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.
  • Participants will be excluded if it is a medical requirement that they receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, diazepam, temazepam, lorazepam, midazolam, triazolam, lovastatin, simvastatin, fentanyl.
  • Psychiatric exclusion criteria:
  • Current or past history of psychiatric conditions encompassing mania or psychosis, including: schizophrenia; psychotic disorder; bipolar I or bipolar II disorder; mania - as determined by DSM-5
  • First degree relative with diagnosed schizophrenia, psychotic disorder (unless substance-induced or due to a medical condition), bipolar I or II disorder or mania
  • Current or past history within the last 12 months of meeting DSM-5 criteria for alcohol or drug dependence (excluding caffeine and nicotine), as determined by clinical interview with the research team and use of screening measures (DAST-10 and AUDIT).
  • Currently meets DSM-5 criteria for dissociative Disorder, or any psychiatric conditions (including personality disorders/borderline personality disorder) judged to be incompatible with establishment of therapeutic rapport or safe exposure to psilocybin (as determined by clinical interview with the research staff).
  • Lifetime history of serious suicide attempts or severe self-harm requiring hospitalisation; or current suicidal ideation with intent. If necessary, during enrolment the research team will use Columbia suicide severity rating scale to assess suicidal ideation. For individuals who are consented and screened, the individual current medical team will be notified with an explanation as to why they were disqualified. Permission for this contact will be obtained from the participant.
  • Unprocessed trauma, as determined by the Adverse Childhood Events (ACE) scale; the PTSD Checklist (PCL-5) and the Life Events Checklist for DSM-5, in consultation with research staff
  • General exclusion criteria:
  • Patients in treatment in another clinical trial involving an investigational product.
  • Prior allergy, hypersensitivity or adverse reaction to psychedelic substances
  • Participants without consistent access to an email address and/or mobile phone for duration of study
  • Past 12-month use of any hallucinogen or psychedelic (including psilocybin, MDMA, LSD, mescaline, DMT, and other similar hallucinogenic compounds)
  • Participants will be excluded if they use any illicit or extra-medical drugs or alcohol within the 2 days prior to each psilocybin dosing, as determined by a urine drug test prior to dosing sessions
  • Any current personal of situational factors that, in the opinion of the research, might interfere with participation (for example, lacking social support, lacking a stable living situation, current domestic violence, or other ongoing trauma). Assessed using a series of questions devised for this trial.
  • Participants who are unable to give adequate informed consent
  • Participants who cannot identify a consenting nominated support person to participate in the study

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2024-05-15
    End: 2025-06-03
  • Compound
    Psilocybin
  • Topic
    Eating Disorders

Locations

Unknown facility — Australia

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