Table 1 Risk mitigation strategies
Adverse Effect | Risk Mitigation Strategy |
|---|---|
Cardiac: • Hypertension • Tachycardia • Prolonged QT interval | 1) Obtain vital signs: heart rate, blood pressure, and orthostatic vital signs  a) When: at initial medical screening, 24–48 h prior to psilocybin dosing, just prior to psilocybin dosing, and every 1–2 h after administration  b) Participants with medical instability requiring medical intervention should not be dosed  c) Participants who develop dangerous and/or persistent hypertension and/or tachycardia during psilocybin administration may require rescue medications for immediate stabilization (consider clonidine, nitroglycerin, propranolol) 2) Measure serum electrolytes  a) When: at study entry and 24–48 h prior to each psilocybin administration 3) Obtain ECG  a) When: at medical screening  b) Participants with abnormal ECGs should be evaluated for participation by a cardiologist or other appropriate medical provider |
Headache | 1) Require maintenance of typical daily caffeine intake during study 2) Require intake of nutrition and electrolyte-containing beverages*  a) When: prior to psilocybin dosing and at regular intervals throughout psilocybin dosing day 3) Utilization of acetaminophen or ibuprofen  a) When: prophylactic on the morning before dosing or as needed following dosing 4) Consider incorporation of relaxation or biofeedback techniques 5) For participants with migraines, triptans are contraindicated around psilocybin administration given risk of serotonin syndrome |
Nausea | 1) Require intake of nutrition*  a) When: prior to psilocybin dosing and at regular intervals throughout psilocybin dosing day 2) Optimize constipation/bowel regimen through medication and diet  a) When: weeks prior to dosing 3) Behavioral strategies to mitigate nausea  a) When: potentially during dosing if nausea occurs 4) Ondansetron, prochlorperazine, and diphenhydramine are contraindicated |
Dizziness | 1) Require intake of nutrition and electrolyte-containing beverages*  a) When: prior to psilocybin dosing and at regular intervals throughout psilocybin dosing day 2) Obtain orthostatic vital signs  a) When: at screening visit and 24 to 48 h prior to doing day  b) Patients with symptomatic orthostasis should not be dosed. 3) Staff to provide ambulatory support during any participant positional changes  a) When: during dosing day |