None listed
Conditions
Brief summary
Psilocybin is quickly becoming a promising treatment for mental illness and is being studied widely due to its profound consciousness-altering properties. We want to better understand (1) how the consciousness-altering properties of psilocybin affect the brain and, (2) how contextual factors, such as mindset and environmental setting can impact the psilocybin experience. Healthy adults ages between 18-55 years who are residing in Victoria, Australia are recruited. Eligible adults will be asked to attend our research facilities in Clayton on two occasions to undergo a Magnetic Resonance Imaging (MRI) and Electroencephalography (EEG). On the second visit, participants will be administered a moderate dose of psilocybin before undergoing the MRI and EEG. Throughout the study, participants will also be asked to complete an interview and online questionnaires, where they will be asked about their health and wellbeing. All participants will also be asked to attend one or more sessions designed to prepare participants for the psilocybin experience in a research setting. The main aim of this study is to improve our understanding of the neural mechanisms of psilocybin by applying computational modelling to (structural, functional and diffusion) MRI and EEG data collected from healthy adults while they are experiencing the acute effects of psilocybin. We will also investigate the influence of contextual factors to enhance the comfort of participants, such as the use of music and meditation during administration and meditation training prior to administration of psilocybin.
Interventions
- 60 healthy participants will undergo fMRI (approx. 60 minutes) followed by and EEG (approx. 90 minutes hour) scans at two time points: [1] Approximately 1 week before oral capsule administration of 19mg psilocybin (baseline), [2] Day of psilocybin administration.
- Eligible participants are randomly stratified by age and sex then selected based on inexperience with use of classic psychedelics. All selected participants will be prepared with information about the effects of psilocybin and wil
- 60 healthy participants will undergo fMRI (approx. 60 minutes) followed by and EEG (approx. 90 minutes hour) scans at two time points: [1] Approximately 1 week before oral capsule administration of 19mg psilocybin (baseline), [2] Day of psilocybin administration. - Eligible participants are randomly stratified by age and sex then selected based on inexperience with use of classic psychedelics. All selected participants will be prepared with information about the effects of psilocybin and will undergo scanning procedures during baseline scanning. - After Psilocybin ingestion, onset period lasting approximately 75 minutes will precede MRI/EEG scanning. Administering study doctor will ensure capsules are swallowed. - Approx. 60 minutes MRI scans run by a radiologist will be accompanied by naturalistic visual stimuli and meditation (open awareness) and music (ambient ethereal) to examine the influence of contextual factors on behavioural measures and brain connectivity. MRI is non-invasive imaging with no tracer/dye injection required. - Approx. 90 minutes EEG scans run by research staff will include rest, guided meditation (open awareness) and music (participant selected and ambient ethereal). EEG electrodes will be placed on the scalp for recording electrical measurements. - Training in meditation practice (mindfulness, focused attention, open awareness and self-compassion) will be delivered to half (30) participants in approximately 60 minutes session each week for 8 weeks. Participants will meditate daily for approximately 20 minutes with the option of guided meditation resources (Sam Harris meditation app). Adherence to meditation will be measured using FFMQ, MAQ, MEDI, EQ and SCS measures and weekly reflection questionnaires provided to participants.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adults aged between 18-55. No MRI 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 is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent. (Funds available for this research would preclude access to translators to enable non-English speaker participation.) Limited previous exposure to psychedelics and meditation practices.
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. Immediate family member with a diagnosed psychotic disorder (Schizophrenia spectrum, Disorder or Bipolar I or II Disorder). History of suicide attempts. No use of any hallucinogen or psychedelic (including psilocybin, MDMA, LSD, mescaline, DMT, and other similar hallucinogenic compounds) within the past 6 months. Taking a contraindicated medication (SSRIs, SNRIs, MAOIs) at the time of recruitment. Currently 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. Hepatic dysfunction. Renal insufficiency (creatinine clearance < 40 mL/min using the Cockraft and Gault equation). Body weight < 48kg. Taking long-acting opioid pain medications (e.g. oxycodone sustained release, morphine sustained release -- which are usually taken at 12-hour intervals) unless 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 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. Positive pregnancy test at screening or during the study. Are unable to give adequate informed consent. Allergy to gelatine or lactose.
Outcome results
None listed