Does psilocybin alter the brain's response to food choice and reward?
The neuronal mechanisms underlying food choice and reward under psilocybin in healthy adults
Monash University
10 participants
Aug 1, 2024
Interventional
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria20
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
- 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.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624000910505