Does psilocybin alter the brain's response to... — Clinical Trial Details

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.

Participants

Ages

20 – 50

Sexes

Male & Female

BMI

Psychosis History

Excluded

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Psilocybin 20 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details