RecruitingPhase 1NCT07347405

Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.

A Randomized Double-masked Dose-controlled Trial to Assess the Tolerability, Safety, Subjective Experience, and Efficacy of Repeated Administration of Three Different Doses of Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.


Sponsor

Francisco A Moreno

Enrollment

30 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The study tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes activity in brain areas involved in OCD. 30 patients with moderate or more severe OCD who are not taking mind altering medications or street drugs will participate in a 12 week study. Participants will be assigned (by luck of the draw) to take a low, medium, or high dose whole psilocybin mushroom contained in three chocolate pieces, prepared for this study by the Scottsdale Research Institute.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing psilocybin — the active compound from certain mushrooms — as a treatment for obsessive-compulsive disorder (OCD). It is designed for people with moderate to severe OCD who haven't responded well to standard treatments. Participants will receive whole mushroom psilocybin in a supervised clinical setting. **You may be eligible if...** - You are 18 or older - You have been diagnosed with OCD and have at least moderate severity (YBOCS score of 16 or higher) - You have tried at least one standard OCD treatment (like therapy or an antidepressant) without adequate benefit - You can safely live independently **You may NOT be eligible if...** - You have a current substance use disorder or personal or family history of psychosis or bipolar disorder - You have significant heart, kidney, or liver problems - You have attempted suicide in the past 12 months - You are currently taking antidepressants, antipsychotics, or other medications that interact with psilocybin (must be stopped in advance) - You are pregnant, breastfeeding, or planning to become pregnant - You have a weight below 45 kg or are allergic to chocolate or cocoa Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin 10 mg

Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.

DRUGPsilocybin 20 mg

Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.

DRUGPsilocybin 30 mg

Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.


Locations(1)

The Clinical and Translational Sciences Research Center

Tucson, Arizona, United States

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NCT07347405


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