Psilocybin for Obsessive-Compulsive Disorder
Trial Summary
What is the purpose of this trial?
This trial tests if taking psilocybin pills can help people with OCD by changing how their brain processes thoughts and emotions. The study compares different amounts of psilocybin to see if it reduces OCD symptoms more effectively. Psilocybin is a naturally occurring substance that has shown promise in treating mood and substance use disorders.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any psychotropic medications for OCD or other psychiatric conditions at least 8 weeks before starting the trial and refrain from taking them until 4 weeks after the second dose of psilocybin.
What data supports the effectiveness of the drug psilocybin for treating obsessive-compulsive disorder?
Research shows that psilocybin may help people with obsessive-compulsive disorder (OCD), with some patients experiencing significant improvements in symptoms after treatment. A case report highlighted a patient with severe OCD who showed marked improvement after a single dose of psilocybin, suggesting its potential as a promising treatment option.12345
Is psilocybin safe for human use?
Psilocybin, found in certain mushrooms, can cause hallucinations and other effects on the brain. While generally considered relatively harmless, there are risks of anxiety, panic reactions, and harmful behaviors, especially if taken in large amounts or if poisonous varieties are mistakenly consumed.56789
How is the drug psilocybin different from other treatments for obsessive-compulsive disorder (OCD)?
Psilocybin is unique because it works by activating specific serotonin receptors in the brain, which may help reduce OCD symptoms. Unlike traditional treatments, psilocybin is a psychedelic compound that can have long-lasting effects after just a single dose, offering a potential alternative for those who do not respond well to standard therapies.24101112
Research Team
Benjamin Kelmendi, MD
Principal Investigator
Yale University
Terence Ching, PhD
Principal Investigator
Yale University
Christopher Pittenger, MD, PhD
Principal Investigator
Yale University
Eligibility Criteria
This trial is for adults with a primary diagnosis of OCD, who have tried at least one standard treatment without success. Participants must be fluent in English, able to take oral pills, not on psychotropic medications or psychotherapy for 8 weeks prior to the study and agree not to start any during the study. They should provide an emergency contact and commit to all procedures including lifestyle changes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Immediate Treatment
Participants receive two doses of oral psilocybin separated by one week, with preparatory and integration sessions
Waitlist Control/Delayed Treatment
Participants enter a waitlist phase for 7 weeks, followed by the same treatment as the immediate group
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants have follow-up visits up to 12 months post-second dose
Treatment Details
Interventions
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- Treatment-resistant depression (TRD) under PRIME designation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Steven & Alexandra Cohen Foundation
Collaborator
Steven & Alexandra Cohen Foundation
Collaborator