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Trial registered on ANZCTR
Registration number
ACTRN12624000910505
Ethics application status
Approved
Date submitted
10/07/2024
Date registered
25/07/2024
Date last updated
25/07/2024
Date data sharing statement initially provided
25/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Does psilocybin alter the brain's response to food choice and reward?
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Scientific title
The neuronal mechanisms underlying food choice and reward under psilocybin in healthy adults
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Secondary ID [1]
312499
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None
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Universal Trial Number (UTN)
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Trial acronym
PsiGusto
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psilocybin-induced changes in food choice
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Psilocybin-induced changes in food reward
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Condition category
Condition code
Mental Health
331002
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
- 10 healthy participants will undergo fMRI scans (approx. 60 minutes) during a food choice task at two time points: [1] Approximately 1 week before oral capsule administration of 20mg psilocybin (baseline), [2] Day of psilocybin administration.
- Eligible participants are selected based on previous experience with use of classic psychedelics (>12 months prior). All selected participants will be prepared with information about the effects of psilocybin at the recruitment stage and again on the baseline scanning day where they will undergo scanning procedures 1 week prior to psilocybin administration.
- After Psilocybin ingestion, onset period lasting approximately 75 minutes will precede fMRI scanning. Administering study doctor will ensure capsule is swallowed.
- Approx. 60 minutes fMRI scans run by a radiologist will be accompanied by a food choice task in combination with an in-scan gustometer that will deliver small volumes (3ml per trial) of liquid food (either high or low calorie drinks) directly into the participant's mouth via a specialised mouthpiece that is positioned into the left side of the mouth. Each trial will be associated with the potential delivery of a low or high calorie drink being dispensed, depending on the choice made by the participant, meaning that some individuals will be provided with both drinks. This will be used to examine the direct influence of psilocybin on the neuronal response to food reward. fMRI is non-invasive imaging with no tracer/dye injection required.
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Intervention code [1]
329019
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Treatment: Drugs
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Comparator / control treatment
Open label, within-subject comparator (i.e. change in response from baseline scan)
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Control group
Active
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Outcomes
Primary outcome [1]
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Changes in brain activation during food choice and reward delivery
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Assessment method [1]
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Functional magnetic resonance imaging
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Timepoint [1]
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Baseline and day of dosing
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Secondary outcome [1]
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Changes in food preferences or views following psilocybin treatment - this will be assessed as a composite outcome
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Assessment method [1]
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Food diary app
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Timepoint [1]
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Baseline and 1 week after dose day
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Secondary outcome [2]
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Subjective ratings mystical experiences arising from acute psychedelic substance ingestion, across all subjects and between groups
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Assessment method [2]
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Assessed using the Mystical Experiences Questionnaire (MEQ).
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Timepoint [2]
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Approximately 6 hours post dose administration.
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Secondary outcome [3]
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Subjective ratings of altered sense of self (ego-dissolution) arising from acute psychedelic substance ingestion, across all subjects and between groups.
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Assessment method [3]
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Assessed using the Ego-Dissolution Inventory (EDI).
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Timepoint [3]
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Approximately 6 hours post dose administration.
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Secondary outcome [4]
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Subjective ratings of altered states of consciousness arising from acute psychedelic substance ingestion.
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Assessment method [4]
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Assessed using the 5-Dimension Altered States of Consciousness (5D-ASC)
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Timepoint [4]
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Approximately 6 hours post dose administration.
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Eligibility
Key inclusion criteria
Age 20-50
No MR contraindications.
Willing to be abstinent from illicit or extra-medical drug and alcohol use for at least 2 days prior to psilocybin dosing.
Able to swallow pills.
Proficient in English, such that their literacy and comprehension are sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
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Minimum age
20
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Current or previously diagnosed psychiatric disorder (as determined by the SCID).
Current or past history within the last 5 years of meeting DSM-5 criteria for alcohol or drug
dependence (excluding caffeine and nicotine), as determined by clinical interview and use of screening measures.
An immediate family member with a diagnosed psychotic disorder (Schizophrenia spectrum Disorder or Bipolar I or II Disorder).
History of suicide attempts.
Use of any hallucinogen or psychedelic (including psilocybin, MDMA, LSD, mescaline, DMT, and other similar hallucinogenic compounds) within the past 12 months.
Taking a contraindicated medication (SSRIs, SNRIs, MAOIs) at the time of recruitment.
Current use of any of the following potent metabolic inducers or inhibitors: Inducers - Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, paclitaxol, St John's Wort; Inhibitors - all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.
Known conditions putting participants at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome.
People with a medical requirement that they receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl.
A diagnosis of epilepsy or previous seizures.
A diagnosis of Hepatic dysfunction or Renal insufficiency
Body weight < 48kg or >100kg.
Taking long-acting opioid pain medications (e.g. oxycodone sustained-release, morphine sustained release -- which are usually taken at 12-hour intervals) unless 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.
Cardiovascular conditions: uncontrolled hypertension, (Systolic >140 and diastolic >90) angina, a previous clinically significant ECG abnormality (e.g. atrial fibrillation, arrhythmia, prolongation of QT/QTc interval), TIA in the last 6 months, stroke or cerebrovascular disease, peripheral or pulmonary vascular disease (no active claudication).
Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc).
Treatment in another clinical trial involving an investigational product.
A positive pregnancy test at initial assessment or during the study.
Are unable to give adequate informed consent.
Allergy to gelatine or lactose.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
30/11/2024
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Actual
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Date of last data collection
Anticipated
20/12/2024
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Biomedical Discovery Institute, Monash University
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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University
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Name [2]
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Inside Out Institute, University of Sydney
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Address [2]
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Country [2]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
319165
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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03/04/2024
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Approval date [1]
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01/07/2024
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Ethics approval number [1]
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40748
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Summary
Brief summary
Psilocybin is proposed to act via a loosening of cognitive control processes thereby rectifying deeply engrained patterns of thought and behaviour to promote cognitive flexibility. There is also evidence that psychedelics (psilocybin & LSD) alter dopaminergic reward signalling in healthy participants, but whether or not this is associated with responses to food choice or food reward is unknown. This project with use brain imaging techniques to investigate the brain networks that integrate information about the nutritional state of the body (e.g., hunger, satiety) with decision-making systems important to food choice and how they are altered by psilocybin. To do this, we will acquire brain scans of healthy adults before and after they have been administered a single dose of psilocybin, while they are completing an in-scan food choice task using a custom designed liquid food delivery apparatus (a "gustometer"). This information is critical to inform the therapeutic application of psilocybin in eating disorders such as anorexia nervosa, in which patients experience aberrant food reward processing that contributes to their disorder maintenance and relapse. Clinical trials in this patient population are already underway, underscoring the important of obtaining this critical information in a timely manner.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Claire Foldi
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Address
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Department of Physiology, Monash University, 26 Innovation Walk, Clayton, VIC 3800
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Country
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Australia
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Phone
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+61399059158
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Claire Foldi
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Address
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Department of Physiology, Monash University, 26 Innovation Walk, Clayton, VIC 3800
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Country
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Australia
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Phone
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+61399059158
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Claire Foldi
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Address
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Department of Physiology, Monash University, 26 Innovation Walk, Clayton, VIC 3800
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Country
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Australia
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Phone
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+61399059158
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Deidentified individual participant data will be available for all study outcomes (neuroimaging datasets and all secondary measures), however some demographic information may be withheld to protect participant confidentiality given the small sample size.
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When will data be available (start and end dates)?
Start: Immediately following the publication of the main brain imaging findings.
End: 5 years after the completion of data collection
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Available to whom?
Data will be made available on a case-by-case basis at the discretion of the principal investigator/primary sponsor.
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Available for what types of analyses?
Any purpose.
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How or where can data be obtained?
Access subject to approval by Principal Investigator (Claire Foldi;
[email protected]
)
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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.
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