PsiConnect: Brain Connectivity and Context under Psilocybin

Phase 1

Completed

• Conditions: eural mechanisms of psilocybin induced altered-states of consciousness; Neural mechanisms of psilocybin induced altered-states of consciousness; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12621001375842
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-11
• Study Completion: 2024-02-15
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified