Does psilocybin alter the brain's response to food choice and reward?

Phase 1

• Conditions: Psilocybin-induced changes in food choice; Psilocybin-induced changes in food reward; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12624000910505
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-25
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in brain activation during food choice and reward delivery [Functional magnetic resonance imaging Baseline and day of dosing]

Secondary Outcome Measures

Name	Time	Method
Changes in food preferences or views following psilocybin treatment - this will be assessed as a composite outcome[Food diary app Baseline and 1 week after dose day];Subjective ratings mystical experiences arising from acute psychedelic substance ingestion, across all subjects and between groups[Assessed using the Mystical Experiences Questionnaire (MEQ). Approximately 6 hours post dose administration.];Subjective ratings of altered sense of self (ego-dissolution) arising from acute psychedelic substance ingestion, across all subjects and between groups.[Assessed using the Ego-Dissolution Inventory (EDI). Approximately 6 hours post dose administration.];Subjective ratings of altered states of consciousness arising from acute psychedelic substance ingestion. [Assessed using the 5-Dimension Altered States of Consciousness (5D-ASC) Approximately 6 hours post dose administration.]