Actively Recruiting
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Led by Johns Hopkins University · Updated on 2026-02-13
20
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
R
Rose Hill
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.
CONDITIONS
Official Title
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over age 18 years, inclusive.
- Ischemic or hemorrhagic stroke confirmed by CT or MRI at least 12 months prior to admission.
- Ability to give informed consent and understand the study tasks.
- Willingness to avoid new prescription medications without study team approval during the study.
- Willingness to avoid herbal supplements without prior research team approval.
- Willingness to avoid nonprescription medications except approved NSAIDs, acetaminophen, vitamins, or other over-the-counter drugs approved by the research team.
- Willingness to follow medication, food, beverage, and nicotine restrictions before psilocybin administration.
- Agree to have transportation arranged after psilocybin administration.
- Willingness to be contacted by telephone as needed.
- Negative pregnancy test if able to bear children.
- Provide a contact person reachable if participant becomes suicidal.
- Agree to inform investigators within 48 hours of new medical conditions or procedures.
- Proficient in speaking and reading English.
- Agree to have clinical visit sessions recorded.
- Agree not to participate in other interventional clinical trials during this study.
You will not qualify if you...
- Use of certain medications within 30 days prior to psilocybin administration, including SSRIs, SNRIs, Bupropion, Valproic acid, Zolpidem, Trazodone, Carbamazepine, tricyclic antidepressants, MAO inhibitors, Mirtazapine, Lithium, Buspirone, atypical antipsychotics, Clonazepam, Gabapentin, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, Topiramate, or Zonisamide.
- History of medically significant suicide attempt.
- Evidence of acute cardiac dysfunction within 48 hours prior to administration.
- Uncontrolled high or low blood pressure readings during a 7-day monitoring period.
- Blood pressure outside specified limits immediately before psilocybin administration.
- Cognitive impairment preventing use of study device.
- Physical or neurological conditions interfering with study procedures or motor assessments.
- Social or personal circumstances limiting follow-up.
- Pregnancy or nursing.
- Body weight less than 48 kg.
- Inability to give informed consent.
- Active abuse of opioids, cocaine, PCP, amphetamines, or alcohol.
- Moderate or severe substance use disorder.
- Diagnosis of schizophrenia, past psychosis, hospitalization for anxiety, or Type 1 bipolar disorder.
- Certain electrolyte imbalances and kidney function impairments.
- Low blood counts or elevated white blood cells.
- Active suicidal ideation as assessed by clinical interview.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
S
Steven R Zeiler, M.D., Ph.D.
CONTACT
V
Victor C Urrutia, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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