A Study of Psychedelics in Healthy Older Adults With Low Well-being

Exclusion Criteria

• •General:
• •Have a known allergic or severe reaction to Psilocybin, Dextromethorphan, or any of the non-active components of the IMP capsules
• •Insufficient ability to report on symptoms to make a valid assessment on any required instrument
• •Have a condition or presence of clinical feature which, in the opinion of the investigators might interfere with or prevent appropriate study participation or interfere with data interpretation
• •MRI Exclusions:
• •Any implanted object or device that poses a safety risk or could interfere with MRI scanning (e.g. aneurysm clips, cardiac pacemakers, defibrillators, neurostimulators, cochlear implants, spinal cord stimulators, insulin or infusion pumps, metallic prostheses or fragments, heart valves, vascular stents, or shunts. surgical staples, clips, or joint replacements, radiation seeds, medication patches containing metal, or any other metallic or electronic implants)
• •History of metallic injury to the eyes or body, or those with tattoos containing metallic ink, permanent makeup, or body piercings that cannot be removed.
• •Any condition that poses a safety risk or could interfere with MRI scanning (e.g. severe claustrophobia or motion disorders or breathing problems, etc)
• •Psychiatric:
• •History of hallucinogen persisting perception disorder (HPPD) (as per DSM-5 criteria)
• •Cardiovascular:
• •Clinically significant cardiovascular conditions e.g., clinically significant EKG abnormalities, transient ischemic attack in the last 6 months, history of hemorrhagic stroke, history of myocardial infarction within 1 year of signing informed consent form (ICF)
• •Baseline (heart rate \< 60 bpm or \> 90 bpm at screening or pre-dose
• •Baseline hypertension (≥140 SBP or ≥90 DBP), after repeated measurements
• •QTc Interval \> 450msec on 12-lead EKG. Note: If QT-prolonging medications are started or increased in dose after enrollment and prior to dosing visit, a repeat EKG must be done \>12-hours after this change to assure continued safe enrollment in the trial
• •Clinically significant arrhythmia (e.g., uncontrolled atrial fibrillation, or untreated supraventricular tachycardia)
• •Any current condition where physical activity is associated with palpitations, anginal pain or syncope
• •General health:
• •Major systemic disorders, including seizure, insulin dependent diabetes mellitus, recent history (last 12 months) of advanced cancer or its treatment (radiation therapy or chemotherapy), had major surgery within 6 months from screening or plans to have surgery while enrolled in the study
• •Inadequate hepatic function as determined by total bilirubin or alkaline phosphatase \>3x institutional upper limit of normal; or aspartate aminotransferase (AST) or alanine transaminase (ALT) \>3x institutional upper limit of normal. However, participants with Gilbert syndrome are allowed to enroll
• •Inadequate renal function as determined by estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 (based on the MDRD equation)
• •Participant is at increased risk of falls