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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

Summary

This study tests whether psilocybin (the active compound in certain mushrooms) can help people with obsessive-compulsive disorder who haven’t responded to standard treatments. In a carefully controlled trial, participants receive either a single dose of psilocybin or a placebo while receiving psychological support, with their brain activity and symptoms monitored. The research aims to determine if this novel treatment is safe and whether it could work faster than existing medications for this difficult-to-treat condition.

Background

Obsessive-compulsive disorder (OCD) affects 2.3-2.7% of the population and is often disabling and chronic. Current treatments like SSRIs and CBT/ERP have limited efficacy with up to 60% of patients showing no response. Psilocybin has shown promise in treating other psychiatric conditions and may modulate brain regions implicated in OCD pathophysiology.

Objective

This trial aims to evaluate the feasibility, safety, and tolerability of single-dose psilocybin (0.25 mg/kg) compared to active placebo (niacin 250 mg) in treatment-refractory OCD. The study will assess clinical effects on OCD symptoms and explore neural mechanisms of action using resting-state fMRI.

Results

This is a protocol paper describing planned study design and procedures rather than results. The study is conducted at Yale University from November 2018 to June 2024 with enrollment of 36 participants to account for 20% attrition.

Conclusion

This first-of-its-kind randomized controlled trial will evaluate psilocybin’s potential as a rapid-acting treatment for refractory OCD. The study may advance understanding of OCD neurobiology and establish feasibility of psychedelic-assisted treatment for this condition.
  • Published in:Frontiers in Psychiatry,
  • Study Type:Clinical Trial Protocol,
  • Source: PMID: 37181888
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