Clinical TrialNeuroimaging & Brain MeasuresPsilocybinNot yet recruiting

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

Open-label, non-randomised single-group fMRI study (n=10) testing a single oral 20 mg psilocybin dose versus baseline to assess changes in brain response to food choice and reward in healthy adults.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Ten healthy adult participants with prior classic psychedelic experience will undergo an fMRI food-choice task at baseline (~1 week before dosing) and on the day of a single 20 mg oral psilocybin dose to assess acute changes in neural responses to food reward.

During the post-dose scan an in‑scanner gustometer will deliver small (3 ml) low- or high-calorie liquid rewards contingent on choices; onset to scan is ~75 minutes after ingestion and scan duration is ~60 minutes.

Study Protocol

Preparation

2 sessions

Dosing

1 sessions
135 min each

Integration

0 sessions

Study Arms & Interventions

Psilocybin 20 mg

experimental

Single oral 20 mg psilocybin capsule; within-subject comparison to baseline fMRI.

Interventions

  • Psilocybin20 mg
    via Oral• single dose• 1 doses total

    Oral capsule; onset ~75 minutes before fMRI; single dosing day with pre-dose baseline scan ~1 week earlier.

Participants

Ages
20 – 50
Sexes
Male & Female

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 within the past 12 months.
  • Taking a contraindicated medication (SSRIs, SNRIs, MAOIs) at the time of recruitment.
  • Current use of 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 to receive certain low therapeutic index drugs within 12 hours after 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) 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.
  • 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 Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2024-08-01
    End: 2024-12-20
  • Compound
    Psilocybin
  • Topic
    Neuroimaging & Brain Measures

Locations

Unknown facility — Australia

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