About this trial
The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over age 18 years, inclusive.
Ischemic or hemorrhagic stroke confirmed by CT or MRI, at least 12 months prior to admission date
Ability to give informed consent and understand the tasks involved.
Agree that, for the study duration, will refrain from: (1) No new prescription medications during the time of the study without approval of the study team, (2) taking any herbal supplement (except with prior approval of the research team), (3) taking any nonprescription medications with the exception of: 1. non-steroidal anti-inflammatory drugs. 2. acetaminophen. 3. vitamins. 4. or other over-the-counter medications approved by the research team
Disqualifiers
selective serotonin reuptake inhibitor (SSRI)
Serotonin-norepinephrine reuptake inhibitors (SNRI)
Buproprion
Valproic acid
Trial design
Parallel
Treatments tested in this trial
Psilocybin (Usona Institute)
DrugParticipants will receive psilocybin to test its safety. Secondary outcomes will assess recovery from post-stroke deficits.
Treatment groups
Trial outcomes
Primary outcomes
Stability of systolic and diastolic blood pressure (mmHg)
Will be measuring the number of participants that meet these criteria: 1. no sustained elevation of systolic blood pressure of more than 180 mmHg on more than two readings sustained for more than 20 minutes. 2. no sustained elevation of diastolic blood pressure of more that 120 mmHg on more than two reading sustained for more than 20 minutes. 3. No sustained reduction of systolic blood pressure of less than 70 mmHg on more than two readings sustained for more than 20 minutes. 4. No sustained reduction of diastolic blood pressure of less than 40 mmHg on more than two readings sustained for more than 20 minutes
Secondary outcomes
Number of adverse changes in vital signs that require medical attention
Adverse change in vital signs, not otherwise meeting specified outcome criteria, that a treating provider feels requires medical intervention.
Number of changes in psychiatric symptoms that require medical intervention
Significant psychiatric symptoms within 24 hours post-dosing as determined by clinical staff to require medical intervention
Stability of pulse assessed by heart rate monitoring
no resting tachycardia for more than 20 minutes defined as heart rate greater than 110 bpm, or resting bradycardia for more than 20 minutes defined as less than 40 bpm.
Oxygen Percent Saturation
Stability of pulse oximetry. No reduction of percent saturation of less than 87% as assess by pulse oximetry on more than two readings sustained for more than 10 minutes.
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
Rose Hill
Collaborator
Usona Institute
Collaborator
University of California, Berkeley
Collaborator