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Safety, feasibility, tolerability, and clinical effects of repeated psilocybin dosing combined with non-directive support in the treatment of obsessive-compulsive disorder: protocol for a randomized, waitlist-controlled trial with blinded ratings

Summary

This clinical trial is investigating whether psilocybin (a psychoactive compound found in certain mushrooms) combined with supportive counseling can help people with treatment-resistant obsessive-compulsive disorder. Researchers will give participants two doses of psilocybin while providing non-directive psychological support to help them process their experiences. The study aims to determine whether this approach is safe, tolerable, and effective at reducing OCD symptoms, and to understand the psychological mechanisms that might explain how it works.

Background

Obsessive-compulsive disorder (OCD) is a chronic disabling condition with limited treatment options, as up to 60% of patients are non-responsive to SSRIs and access to CBT/ERP is limited. Psilocybin has shown promise in early pilot studies for OCD treatment, with one study demonstrating 23-100% symptom reduction. Participant feedback from an ongoing single-dose trial indicated interest in higher fixed doses and multiple administrations for potentially greater therapeutic benefits.

Objective

This randomized, waitlist-controlled trial aims to evaluate the safety, feasibility, tolerability, and clinical effects of two fixed doses of oral psilocybin (25 mg first dose, with second dose either 25 or 30 mg based on response) paired with non-directive psychological support in treating treatment-refractory OCD. The study will examine whether two doses produce greater symptom reduction than one dose and explore psychological mechanisms underlying psilocybin’s effects on OCD.

Results

This is a protocol paper describing planned methodology; results are not yet available as the trial is ongoing from August 2023 to August 2027. The study aims to provide data on safety, feasibility, and clinical efficacy of repeated psilocybin dosing for OCD treatment.

Conclusion

This rigorously designed randomized controlled trial will advance understanding of psilocybin’s therapeutic potential for treatment-refractory OCD through evaluation of safety, feasibility, tolerability, and clinical effects of repeated dosing combined with non-directive psychological support. The study aims to catalyze future research optimizing psilocybin treatment protocols for OCD by elucidating relevant psychological mechanisms of action.
  • Published in:Frontiers in Psychiatry,
  • Study Type:Clinical Trial,
  • Source: PMID: 38264632
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