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Trial registered on ANZCTR


Registration number
ACTRN12624000343505
Ethics application status
Approved
Date submitted
9/02/2024
Date registered
26/03/2024
Date last updated
10/05/2024
Date data sharing statement initially provided
26/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 311494 0
Nil known
Universal Trial Number (UTN)
U1111-1303-9276
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 332825 0
Body image disturbance 332826 0
Condition category
Condition code
Mental Health 329544 329544 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is psilocybin-assisted psychotherapy. All participants will receive a 90-minute preparatory therapy session per week for 4 consecutive weeks (4 sessions total), three doses of an orally administered (tablet form; one 5mg dose; two 25mg doses) psilocybin (week 5, week 6 and week 10), and 7 x 60-90 minute sessions of integration therapy (7 sessions total). Integration therapy occurs in weeks 5, 6, 7, 9, 10, 12, 16 (eg. after each dosing session). Preparation and integration therapy will include manualised body image-specific psychotherapy components but can be individually customised.

All Supports will receive one preparation session and two integration sessions (60 minutes duration per session) that comprise psychoeducation and emotion-focused family therapy (EFFT) strategies to support the participant (no psilocybin dosing). All therapy will be conducted via co-therapist dyad (female/male or female/female).

All participants with anorexia nervosa (AN) will receive three doses of oral psilocybin. The first dose (5mg) occurs in week 5 of the protocol; the second dose (25mg) is administered in week 6; the third dose (25mg) is administered in week 10.

The intervention is 16 weeks post-enrolment. Adherence to the intervention will be monitored via supervised dosing and session attendance checklists.


Intervention code [1] 327959 0
Treatment: Drugs
Intervention code [2] 327960 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337352 0
Feasibility of intervention assessed via:
- Audit of study enrolment data
- Record of session attendance
- Use of withdrawal logs
Timepoint [1] 337352 0
Recruitment period through to 6 month follow-up.
Primary outcome [2] 337353 0
Acceptability of intervention
Timepoint [2] 337353 0
- Attendance from week 1 through to week 16 of active intervention.
- Qualitative semi-structured interview at 16 weeks and 40 weeks
Primary outcome [3] 337354 0
Safety data specific to individuals partially recovered from AN with severe body image disturbance - medical stability
Timepoint [3] 337354 0
HR, BP, ECG, blood test pathology, blood glucose test, drug test are all assessed at screening, baseline; and weeks 7, 10, and 16 post-enrolment.
Secondary outcome [1] 431541 0
To assess changes in BID symptomatology
Timepoint [1] 431541 0
Baseline; weekly through treatment (week 1 - week 16 post-enrolment); monthly from week 16 through to week 40 post-enrolment.
Secondary outcome [2] 431542 0
Assess change in multidimensions of body image disturbance
Timepoint [2] 431542 0
Baseline; weekly through treatment (week 1 - week 16 post-enrolment); monthly from week 16 through to week 40 post-enrolment.
Secondary outcome [3] 431543 0
Assess psilocybin-assisted psychotherapy effects on individual difficulties in emotion regulation.
Timepoint [3] 431543 0
Baseline, end of treatment (16 weeks), 6-month follow-up
Secondary outcome [4] 431544 0
Assess psilocybin-assisted psychotherapy effects on intolerance of uncertainty
Timepoint [4] 431544 0
Baseline, end-of-treatment (16 weeks); 6-month follow-up
Secondary outcome [5] 431545 0
Assess psilocybin-assisted psychotherapy effects on cognitive flexibility
Timepoint [5] 431545 0
Baseline, end-of-treatment (16 weeks); 6-month follow-up
Secondary outcome [6] 431546 0
Assess psilocybin-assisted psychotherapy effects on experiential avoidance
Timepoint [6] 431546 0
Baseline; end of treatment (16 weeks); 6-month follow-up
Secondary outcome [7] 431547 0
Assess psilocybin-assisted psychotherapy effects on clinic impairment due to body image disturbance symptoms
Timepoint [7] 431547 0
Baseline; end-of-treatment (16 weeks); 6-month follow-up
Secondary outcome [8] 431548 0
Assess psilocybin-assisted psychotherapy effects on quality of life
Timepoint [8] 431548 0
Baseline; end-of-treatment (16 weeks); 6-month follow-up
Secondary outcome [9] 432785 0
This is an additional primary outcome: Safety data specific to individuals partially recovered from AN with severe body image disturbance - psychological stability
Timepoint [9] 432785 0
Assessment will occur weekly through to week 16 post-enrolment; monthly from week 16 through to week 40 post-enrolment.
Secondary outcome [10] 432786 0
This is an additional primary outcome: Safety data specific to individuals partially recovered from AN with severe body image disturbance - psychological stability
Timepoint [10] 432786 0
CSRS is administered when indicated by Adverse Event (AE) weekly assessment; if prompted by therapist clinical concerns for the duration of the 16 week intervention; and if prompted via monthly EDE-Q through to week 40 post-enrolment
Secondary outcome [11] 432787 0
This is an additional primary outcome: Safety data specific to individuals partially recovered from AN with severe body image disturbance - psychological stability
Timepoint [11] 432787 0
HPPD-Q is administered week 7 and week 16 post-enrolment
Secondary outcome [12] 432788 0
This is an additional primary outcome: Safety data specific to individuals partially recovered from AN with severe body image disturbance - medical stability
Timepoint [12] 432788 0
Blind weighing will occur at baseline, integration 3 (week 7) and integration 5 (week 10) and end-of-treatment (week 16) - or more frequently as indicated by an increase in EDE-Q and/or therapist clinical concerns
Secondary outcome [13] 432789 0
This is an additional primary outcome: Safety data specific to individuals partially recovered from AN with severe body image disturbance - medical stability
Timepoint [13] 432789 0
BMI (with blind weight) is measured at screening, week 16 and week 40 post-enrolment
Secondary outcome [14] 432790 0
To assess changes in BID symptomatology
Timepoint [14] 432790 0
Baseline, week 16 and week 40 post-enrolment
Secondary outcome [15] 432791 0
Assess change in multidimensions of body image disturbance
Timepoint [15] 432791 0
Baseline, week 16 post-enrolment, week 40 post-enrolment

Eligibility
Key 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.
Minimum age
21 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
10
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315782 0
Charities/Societies/Foundations
Name [1] 315782 0
Barbara Dicker Fund
Country [1] 315782 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Country
Australia
Secondary sponsor category [1] 317907 0
None
Name [1] 317907 0
Address [1] 317907 0
Country [1] 317907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314641 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 314641 0
Ethics committee country [1] 314641 0
Australia
Date submitted for ethics approval [1] 314641 0
08/12/2023
Approval date [1] 314641 0
14/03/2024
Ethics approval number [1] 314641 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132250 0
Prof Susan Rossell
Address 132250 0
Swinburne University, John Street, Hawthorn, Victoria, 3122
Country 132250 0
Australia
Phone 132250 0
+61 3 9214 8653
Fax 132250 0
Email 132250 0
srossell@swinburne.edu.au
Contact person for public queries
Name 132251 0
Claire Finkelstein
Address 132251 0
Swinburne University, John Street, Hawthorn, Victoria, 3122
Country 132251 0
Australia
Phone 132251 0
+61403576066
Fax 132251 0
Email 132251 0
clairefinkelstein@hotmail.com
Contact person for scientific queries
Name 132252 0
Claire Finkelstein
Address 132252 0
Swinburne University, John Street, Hawthorn, Victoria 3122
Country 132252 0
Australia
Phone 132252 0
+61 3 9214 8173
Fax 132252 0
Email 132252 0
cfinkelstein@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.