Actively Recruiting
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability for Safety and Motor Recovery in Chronic Stroke Patients
Led by Johns Hopkins University · Updated on 2026-02-13
20
Participants Needed
1
Research Sites
4 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
Stroke is a leading cause of death and disability worldwide, with many survivors experiencing long-term impairments in language, cognition, motor, and sensory skills. Rehabilitation after stroke is often limited by a critical period during which recovery is most effective. Researchers are exploring whether psychedelic compounds like psilocybin can reopen this critical period, potentially enhancing recovery. This study focuses on evaluating the safety and tolerability of psilocybin in patients with chronic stroke, while also assessing its effects on motor recovery. Participants will receive one of two psilocybin treatments: a single 25 mg dose or two 12.5 mg doses spaced 2 hours apart. The study is randomized and unblinded. The intervention is given under medical supervision, and the research team will closely monitor vital signs and other safety parameters during and after dosing. During the study, participants will undergo assessments including blood pressure, heart rate, oxygen saturation, EKG, and psychiatric symptoms up to 24 hours post-administration. Longer-term evaluations at 30 and 90 days will measure neurological impairment, motor function, arm-hand recovery, cognitive function, gait, and mood using various standardized tests and questionnaires. Safety monitoring includes tracking adverse events and laboratory tests. The total participation time spans from initial dosing through follow-up assessments up to 90 days.
CONDITIONS
Brief Title
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over age 18 years, inclusive.
- Confirmed ischemic or hemorrhagic stroke by CT or MRI at least 12 months before enrollment.
- Ability to give informed consent and understand study tasks.
- Willingness to follow medication and substance restrictions during the study.
- Agree to refrain from new prescription medications without study team approval.
- Agreement to avoid herbal supplements except with prior approval.
- Consent to not participate in other interventional clinical trials during this study.
- Willingness to have transportation arranged after psilocybin administration.
- Proficient in English speaking and reading.
- Negative pregnancy test if able to bear children.
- Provide a contact person reachable in case of suicidal risk.
- Agree to notify investigators of new medical conditions within 48 hours.
- Agree to audio and video recording of clinical sessions.
- Willingness to be contacted by telephone as needed.
You will not qualify if you...
- Use of specific 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 attempts.
- Acute cardiac dysfunction or abnormal EKG within 48 hours before dosing.
- Blood pressure outside specified safe ranges during monitoring and immediately before dosing.
- Cognitive impairment preventing use of study devices.
- Neurological or physical conditions interfering with assessments.
- Social or personal circumstances affecting follow-up ability.
- Pregnancy or nursing.
- Weight less than 48 kg.
- Inability to give adequate informed consent.
- Active substance abuse or moderate to severe substance use disorder.
- Diagnosis of schizophrenia, prior psychosis, hospitalization for anxiety, or Type 1 bipolar disorder.
- Electrolyte imbalances or kidney impairment beyond set thresholds.
- Low blood counts or elevated white blood cells.
- Active suicidal ideation as assessed by study scales.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours post-psilocybin administration
Participants receive psilocybin to test its safety and to explore its effect on motor recovery after stroke.
1 dosing visit and monitoring for up to 24 hours post-dosing
Duration - Up to 90 days
Participants are monitored for safety and motor recovery outcomes after psilocybin treatment.
Visits at Day 1 (prior to dosing), weekly for up to 3 weeks, and at 30 and 90 days post-treatment
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.
V
Victor C Urrutia, M.D.
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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