NCT07053917

Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.

Detailed description

Stroke is the leading cause of death and adult disability worldwide, and every year more than 795,000 people in the United States have a stroke. According to the National Stroke Association, only 10 percent of people who have a stroke recover completely, while 50 percent experience moderate to severe long-term disability, including significant impairment in language, cognition, motor, and sensory skills, which require special care or long-term care in a nursing home or other facility. Therefore, in the United States alone, nearly 400,000 people per year will suffer the lasting debilitating consequences of stroke. Previous studies have indicated that rehabilitation following stroke is constrained by a so-called 'critical' or 'sensitive' period. While this learning window can be extended or enhanced, once the post-stroke rehabilitation critical period has closed, clinically applicable manipulations that can reopen it are lacking. Recently the investigators have shown that the psychedelic compounds like psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxmethamphetamine (MDMA) can reopen a novel critical period for social reward learning. The adage "you can't teach an old dog new tricks" captures a certain truth about the brain. Specifically, a young person's brain is much more malleable (e.g., able to make new motor-memories and store new motor-memories) compared to an adult's brain. Neuroscientists call these periods of heightened sensitivity to input "critical periods." Based on these observations the investigators posit that psychedelic compounds serve as the long sought-after "master key" for unlocking critical periods across the brain. Ongoing preclinical studies are examining this possibility, with the goal of determining the therapeutic potential of psychedelics (including psilocybin) as adjunct therapies for any intervention whose clinical efficacy may be constrained by critical period closure, including post-stroke rehabilitation. The main purpose of the proposed studies is to evaluate the safety and tolerability of psilocybin in stroke patients (Phase 1). as a secondary aim the investigators will collect data on the efficacy of psilocybin in effecting motor recovery in post-stroke patients.

Conditions

• Stroke
• Chronic Stroke
• Intracerebral Haemorrhage
• Intracerebral Haemorrhage (ICH)
• Intracerebral Hemorrhage Basal Ganglia
• Ischemic Stroke
• Ischemic Stroke and Hemorrhagic Stroke
• Hemiparesis After Stroke
• Hemiplegia Following Ischemic Stroke
• Hemiplegia and Hemiparesis
• Hemiplegia and/or Hemiparesis Following Stroke
• Middle Cerebral Artery Stroke

Interventions

Type	Name	Description
DRUG	Psilocybin (Usona Institute)	Participants will receive psilocybin to test its safety. Secondary outcomes will assess recovery from post-stroke deficits.

Timeline

• Start date: 2026-02-09
• Primary completion: 2027-02-01
• Completion: 2027-03-01
• First posted: 2025-07-08
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study