30 Participants Needed

Psilocybin for Obsessive-Compulsive Disorder

Recruiting at 3 trial locations
YO
TC
BK
Overseen ByBenjamin Kelmendi, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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

BK

Benjamin Kelmendi, MD

Principal Investigator

Yale University

TC

Terence Ching, PhD

Principal Investigator

Yale University

CP

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

Agree to commit to all study procedures
English fluency
If participant is of childbearing potential, must have a negative pregnancy test at study entry and prior to each dosing session
See 9 more

Exclusion Criteria

I do not have any health conditions that could make the study unsafe for me.
Active suicidal intent or suicidal or non-suicidal self-injurious behaviors
Unwillingness or inability to abstain from alcohol use at least 24 hours prior to the days of dosing, up to 24 hours after each dosing day (or corresponding intervals for waitlist group)
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Treatment

Participants receive two doses of oral psilocybin separated by one week, with preparatory and integration sessions

2 weeks
4 visits (in-person)

Waitlist Control/Delayed Treatment

Participants enter a waitlist phase for 7 weeks, followed by the same treatment as the immediate group

7 weeks
1 visit (in-person) for rescreening

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (virtual)

Long-term Follow-up

Participants have follow-up visits up to 12 months post-second dose

12 months
Periodic visits (virtual)

Treatment Details

Interventions

  • Psilocybin
Trial OverviewThe trial tests how repeated doses of psilocybin affect OCD symptoms compared to a waitlist group. It's randomized and includes blinded ratings. The goal is also to understand psychological processes that might explain psilocybin's potential benefits in treating OCD.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate TreatmentExperimental Treatment1 Intervention
Participants randomized to this condition will receive treatment immediately, facilitated by two study staff members, and which consists of two preparatory sessions, followed by the first dosing session and two integration sessions, then the second dosing session and two integration sessions. This is followed by follow-up and long-term follow-up visits up to 12 months post-second dose.
Group II: Waitlist Control/Delayed TreatmentActive Control1 Intervention
Participants randomized to this condition will first enter a waitlist phase that lasts for 7 weeks, after which rater unblinding will occur, and participants will be rescreened. If participants remain eligible at this time, they will begin their treatment phase. During their treatment phase, participants in this condition will receive the same treatment as described for participants in the immediate treatment group. This is followed by follow-up and long-term follow-up visits up to 12 months post-second dose.

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Psilocybin for:
  • Treatment-resistant depression (TRD) under Breakthrough Therapy designation
🇪🇺
Approved in European Union as Psilocybin for:
  • Treatment-resistant depression (TRD) under PRIME designation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Steven & Alexandra Cohen Foundation

Collaborator

Trials
10
Recruited
320+

Steven & Alexandra Cohen Foundation

Collaborator

Trials
5
Recruited
150+

Findings from Research

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.
The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.
[Treatment with psilocybin: applications for patients with psychiatric disorders].Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]
Psilocybin may offer a promising and safe treatment option for obsessive-compulsive disorder (OCD), which is often inadequately addressed by current therapies.
The chapter discusses the mechanisms of action of psilocybin and its potential efficacy in treating OCD, highlighting the need for further research in this area.
Psilocybin for the Treatment of Obsessive-Compulsive Disorders.Ehrmann, K., Allen, JJB., Moreno, FA.[2022]
A case study of a patient with refractory obsessive-compulsive disorder (OCD) showed significant improvement in symptoms after treatment with psilocybin, with the Yale-Brown Obsessive Compulsive Scale (YBOCS) score decreasing from 24 to 0-2 over a year.
The treatment not only reduced OCD symptoms but also led to positive changes in the patient's emotional well-being, social interactions, and overall quality of life, highlighting the potential of psilocybin as a therapeutic option for OCD.
Single-dose psilocybin for treatment-resistant obsessive-compulsive disorder: A case report.Kelmendi, B., Kichuk, SA., DePalmer, G., et al.[2023]

References

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
Psilocybin for the Treatment of Obsessive-Compulsive Disorders. [2022]
Single-dose psilocybin for treatment-resistant obsessive-compulsive disorder: A case report. [2023]
Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. [2022]
The pharmacology of psilocybin. [2016]
[Hallucinogenic mushrooms]. [2018]
The danger of hallucinogenic mushrooms. [2017]
Poisoning by hallucinogenic mushroom hikageshibiretake (Psilocybe argentipes K. Yokoyama) indigenous to Japan. [2019]
Intravenous mushroom poisoning. [2019]
Safety, tolerability, and clinical and neural effects of single-dose psilocybin in obsessive-compulsive disorder: protocol for a randomized, double-blind, placebo-controlled, non-crossover trial. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Long-term Amelioration of OCD Symptoms in a Patient with Chronic Consumption of Psilocybin-containing Mushrooms. [2022]
SAR of psilocybin analogs: discovery of a selective 5-HT 2C agonist. [2016]