Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability

Launched by JOHNS HOPKINS UNIVERSITY · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether psilocybin—a substance found in certain mushrooms—can be safely used to help people who have had a stroke more than a year ago. The main goal is to see if taking psilocybin is safe and well-tolerated in adults who have experienced different types of strokes, such as those caused by a blocked blood vessel or bleeding in the brain. This study is still in the early stages and has not started recruiting participants yet.

To take part, individuals need to be over 18 years old and have had a stroke confirmed by brain scans at least 12 months before joining the study. Participants must be able to understand the study and give their consent. They will need to avoid starting new medications or certain supplements without approval during the study and follow guidelines about food, drink, and smoking before receiving psilocybin. After the treatment, they won’t be allowed to drive themselves home and should have someone to support them. The study team will keep in touch by phone and record the sessions for safety and review. People with certain health issues, who are pregnant, or taking specific medications may not be eligible. Overall, this study aims to carefully check the safety of psilocybin in stroke survivors to see if it might be a helpful addition to their recovery in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Are willing to follow restrictions and guidelines concerning medications, consumption of food, beverages, and nicotine the night before and just prior to psilocybin administration.
• • Agree to have transportation other than driving themselves home or to where the participants are staying after the administration of psilocybin.
• • Are willing to be contacted via telephone for all necessary telephone contacts.
• • Must have a negative pregnancy test if able to bear children.
• • Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal.
• • Must agree to inform the investigators within 48 hours of any new medical conditions and procedures.
• • Are proficient in speaking and reading English.
• • Agree to have all clinical visit sessions recorded to audio and video.
• • Agree to not participate in any other interventional clinical trials during the duration of this study.
• Exclusion Criteria:
• * Taking one of the following medications in the 30 days prior to psilocybin administration:
• • 1. selective serotonin reuptake inhibitor (SSRI)
• • 2. Serotonin-norepinephrine reuptake inhibitors (SNRI)
• • 3. Buproprion
• • 4. Valproic acid
• • 5. Zolpidem
• • 6. Trazodone
• • 7. Carbamazepine.
• • 8. tricyclic antidepressants
• • 9. Monoamine Oxidase Inhibitors
• • 10. Mirtazapine
• • l. Lithium m. Buspirone n. Atypical antipsychotics o. Zolpidem p.Carbamazepine q. Clonazepam r. Gabapentin s. Lamotrigine t. Levetiracetam u. Phenobarbital v. Phenytoin w. Topiramate x. Valproic Acid y. Zonisamide
• • History of medically significant suicide attempt.
• • Evidence of acute cardiac dysfunction as evidenced by either elevated troponin or EKG changes within 48 hours of administration.
• • Systolic blood pressure that is greater than 150 mmHg systolic on \> 2 readings during the 7-day monitoring period AND blood pressure medication management has been assured.
• • Diastolic blood pressure that is greater than 100 mmHg systolic on \> 2 readings during the 7-day monitoring period AND blood pressure medication management has been assured.
• • Systolic blood pressure is less than 90 mmHg systolic on \> 2 readings during the 7-day monitoring period after blood pressure medication management has been assured.
• • Diastolic blood pressure is less than 30 mmHg systolic on \> 2 readings during the 7-day monitoring period after blood pressure medication management has been assured.
• • Systolic blood pressure exceeds 160 mmHg or is less than 90 mmHg immediately prior to administration of psilocybin; patients are allowed to be on anti-hypertensives.
• • Diastolic blood pressure exceeds 100 mmHg or is less than 30 mmHg immediately prior to administration of psilocybin; patients are allowed to be on anti-hypertensives.
• • Cognitive impairment that, in the estimation of the study team, would preclude the use of the MindPod Dolphin.
• • History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
• • Social and/or personal circumstances that interfere with ability to perform follow up assessments.
• • Are pregnant or nursing.
• • Weigh less than 48 kg.
• • Are not able to give adequate informed consent.
• • Are actively abusing opioids, cocaine, Phencyclidine (PCP), amphetamines, or alcohol.
• • Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5) criteria for moderate or severe substance use disorder
• • Diagnosis of schizophrenia, history of prior psychosis, anxiety requiring hospitalization, or Type 1 bipolar.
• • Hypernatremia
• • Hypokalemia (but can have received repletion during the prior 24 hours)
• • Hyperkalemia
• • Glomerular filtration rate of \< 30 ml/min
• • Elevated of white blood cell count
• • Hemoglobin \< 7 g/dl
• • Platelet count \< 100,000 g/dl
• • Acute cardiac dysfunction demonstrated by either troponin elevation (chronic elevation is acceptable), or EKG changes suggestive of acute coronary syndrome.
• • Active suicidal ideation as assess by the C-SSRS.