30 Participants NeededMy employer runs this trial

Psilocybin for OCD

(Mushroom-OCD Trial)

Tc
SC
Overseen ByStudy Coordinator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests psilocybin, a compound found in certain mushrooms, to determine its effectiveness in helping people with obsessive-compulsive disorder (OCD) manage their symptoms. Participants will receive one of three randomly assigned doses of psilocybin chocolate to assess its impact on OCD. Ideal candidates have moderate to severe OCD, have not found success with other treatments, and are not currently using mind-altering drugs. As a Phase 1 trial, this research aims to understand how psilocybin works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications and supplements at least two weeks before starting the trial. This includes antidepressants, antipsychotics, and serotonin-acting supplements. If you're taking fluoxetine, it must be stopped at least six weeks prior.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

Research has shown that psilocybin, found in certain mushrooms, is generally safe when used in a controlled environment. One study found that doses up to 10 mg were well-tolerated by people with OCD, with no serious side effects. Another study demonstrated that multiple doses could be safely administered in a research setting. Psilocybin has also been used safely in other trials, showing potential benefits for people with OCD. Although this trial is just starting, these findings suggest that psilocybin is well-tolerated by most people when given under supervision.12345

Why do researchers think this study treatment might be promising for OCD?

Most treatments for OCD, like SSRIs and cognitive behavioral therapy, focus on managing symptoms over time. But the psilocybin whole mushroom treatment is different. It's derived from a naturally occurring psychedelic compound found in mushrooms, which is thought to work by disrupting negative thought patterns and potentially rewiring brain connectivity. Researchers are excited because psilocybin has shown promise in producing rapid and lasting effects, possibly offering relief in just a single or few doses compared to the weeks or months required for traditional treatments. Plus, it’s administered in a novel chocolate matrix, which could make the experience more palatable and pleasant for patients.

What evidence suggests that psilocybin might be an effective treatment for OCD?

Research has shown that psilocybin, a substance found in certain mushrooms, may help treat obsessive-compulsive disorder (OCD). In one study, psilocybin greatly reduced OCD symptoms, with about 30% of participants noticing improvements. Another study discovered that just one dose of psilocybin quickly reduced compulsive symptoms, with effects lasting up to a week. Additionally, taking psilocybin multiple times during the first month of treatment provided significant relief from symptoms. These findings suggest that psilocybin could effectively manage OCD symptoms. In this trial, participants will receive different doses of psilocybin to evaluate its effectiveness and safety in treating OCD.14678

Who Is on the Research Team?

FM

Francisco Moreno, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults with moderate or severe OCD who have not improved after trying at least one standard treatment. Participants must not be taking mind-altering medications, street drugs, or certain supplements and should be able to live independently.

Inclusion Criteria

I am not taking medications like efavirenz or lorcaserin.
I have been diagnosed with OCD by a professional using the SCID.
I am 18 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preparation

Participants attend a preparation session with a study therapist before dosing

1 week
1 visit (in-person)

Treatment

Participants receive four different doses of psilocybin mushroom chocolate, separated by about three weeks

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Monthly contact

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin Whole Mushroom

Trial Overview

The study tests three different doses (10 mg, 20 mg, or 30 mg) of whole psilocybin mushroom given in chocolate form to see if it helps treat OCD. Participants are randomly assigned a dose and followed for 12 weeks.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Middle dose 20 mgExperimental Treatment1 Intervention
Group II: Low dose 10 mgExperimental Treatment1 Intervention
Group III: High dose 30 mgExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Francisco A Moreno

Lead Sponsor

Arizona Biomedical Research Commission (ABRC)

Collaborator

Trials
3
Recruited
210+

Citations

NCT07347405 | Psilocybin Whole Mushroom for the ...

The study tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes ...

Psychedelics for the Treatment of Obsessive–Compulsive ...

The effects of psilocybin were then systematically assessed in a small, open-label trial in 2006, which found that psilocybin significantly reduced the symptoms ...

Striking long-term beneficial effects of single dose ...

Secondary outcome measures such as head-body twitches and anxiety all showed a significant improvement over 21 days. Notably, in mice that ...

Systematic analysis reveals psilocybin's impact on ...

Participants reported significant improvements in obsessive-compulsive symptomatology following psilocybin use, with approximately 30 percent of ...

Efficacy of Psilocybin in OCD: a Double-Blind, Placebo- ...

This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41825921/

A randomized clinical trial of repeated doses of psilocybin ...

Conclusions: Administration of up to eight doses of psilocybin in a clinical research setting appears to be safe and potentially effective for ...

Single-dose (10 mg) psilocybin reduces symptoms in ...

10 mg of oral psilocybin was acceptable for and well-tolerated by patients with OCD. •. Psilocybin produced a rapid-onset, moderate to large effect on obsessive ...

Safety, tolerability, and clinical and neural effects of single- ...

This first-of-its-kind trial aims to evaluate the feasibility, safety, and tolerability of psilocybin in the treatment of OCD.