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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?
Scientific title
The neuronal mechanisms underlying food choice and reward under psilocybin in healthy adults
Secondary ID [1] 312499 0
None
Universal Trial Number (UTN)
Trial acronym
PsiGusto
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psilocybin-induced changes in food choice 334358 0
Psilocybin-induced changes in food reward 334557 0
Condition category
Condition code
Mental Health 331002 331002 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329019 0
Treatment: Drugs
Comparator / control treatment
Open label, within-subject comparator (i.e. change in response from baseline scan)
Control group
Active

Outcomes
Primary outcome [1] 338769 0
Changes in brain activation during food choice and reward delivery
Timepoint [1] 338769 0
Baseline and day of dosing
Secondary outcome [1] 437384 0
Changes in food preferences or views following psilocybin treatment - this will be assessed as a composite outcome
Timepoint [1] 437384 0
Baseline and 1 week after dose day
Secondary outcome [2] 437674 0
Subjective ratings mystical experiences arising from acute psychedelic substance ingestion, across all subjects and between groups
Timepoint [2] 437674 0
Approximately 6 hours post dose administration.
Secondary outcome [3] 437675 0
Subjective ratings of altered sense of self (ego-dissolution) arising from acute psychedelic substance ingestion, across all subjects and between groups.
Timepoint [3] 437675 0
Approximately 6 hours post dose administration.
Secondary outcome [4] 437676 0
Subjective ratings of altered states of consciousness arising from acute psychedelic substance ingestion.
Timepoint [4] 437676 0
Approximately 6 hours post dose administration.

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.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316920 0
University
Name [1] 316920 0
Biomedical Discovery Institute, Monash University
Country [1] 316920 0
Australia
Funding source category [2] 316922 0
University
Name [2] 316922 0
Inside Out Institute, University of Sydney
Country [2] 316922 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319165 0
None
Name [1] 319165 0
Address [1] 319165 0
Country [1] 319165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315675 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315675 0
Ethics committee country [1] 315675 0
Australia
Date submitted for ethics approval [1] 315675 0
03/04/2024
Approval date [1] 315675 0
01/07/2024
Ethics approval number [1] 315675 0
40748

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

Contacts
Principal investigator
Name 135466 0
Dr Claire Foldi
Address 135466 0
Department of Physiology, Monash University, 26 Innovation Walk, Clayton, VIC 3800
Country 135466 0
Australia
Phone 135466 0
+61399059158
Fax 135466 0
Email 135466 0
claire.foldi@monash.edu
Contact person for public queries
Name 135467 0
Claire Foldi
Address 135467 0
Department of Physiology, Monash University, 26 Innovation Walk, Clayton, VIC 3800
Country 135467 0
Australia
Phone 135467 0
+61399059158
Fax 135467 0
Email 135467 0
claire.foldi@monash.edu
Contact person for scientific queries
Name 135468 0
Claire Foldi
Address 135468 0
Department of Physiology, Monash University, 26 Innovation Walk, Clayton, VIC 3800
Country 135468 0
Australia
Phone 135468 0
+61399059158
Fax 135468 0
Email 135468 0
claire.foldi@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
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
Available to whom?
Data will be made available on a case-by-case basis at the discretion of the principal investigator/primary sponsor.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approval by Principal Investigator (Claire Foldi; claire.foldi@monash.edu)


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.