An Open-Label Multidose Psilocybin Intervention for Obsessive-Compulsive Disorder
Abstract
<h4>Importance</h4> Obsessive-Compulsive Disorder (OCD) has a 2% global prevalence, but only about 50% of patients respond to conventional treatment, underscoring the need for additional effective interventions. <h4>Objective</h4> To assess the feasibility, safety, and preliminary evidence for efficacy of repeated psilocybin administration in OCD patients who had previously attempted psychotherapy or pharmacotherapy. <h4>Design</h4> Waitlist-controlled open label randomized clinical trial. <h4>Setting</h4> Data were collected at the Johns Hopkins University School of Medicine. <h4>Participants</h4> Data were analyzed from 30 participants (total randomized N=37, by age, sex and OCD severity) with a failed previous attempt at either pharmacotherapy or evidence-based psychotherapies such as exposure response prevention (ERP). <h4>Intervention</h4> Participants received two psilocybin doses over two weeks (20 mg followed by 30 mg, if well-tolerated) under supportive conditions. The immediate-treatment arm received the drug within a month following enrollment, and the waitlist-control arm received identical support and dosing after an 8-week waiting period. <h4>Main Outcome</h4> Clinician-administered Y-BOCS scores was collected one week post each drug administration and one month post session 2. Self-assessed reports were collected for acute subjective effects (Mystical Experience Questionnaire (MEQ), Challenging Experience Questionnaire (CEQ), and 11-Dimensional Altered States of Consciousness (11D-ASC)), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory-II (BDI-II), and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). <h4>Results</h4> A total of 37 participants were enrolled in the study (age: 38.4±11.6 years; 21 [56.75%] female), with 30 [81.08%] completing the 1-month follow-up. We show that two successive doses of psilocybin over two weeks were well-tolerated, leading to reduction in OCD symptoms. Compared with the waitlist group (N=14), the immediate-treatment group (N=16) showed a reduction in the Y-BOCS scores (F(2,56)=16.17, p<0.001, η 2 □=0.37) post session. This improvement persisted one month after the second psilocybin dose for both groups post treatment crossover for waitlisted group (F(3,84)=29.91, p<0.001, η 2 □=0.52). Y-BOCS scores were correlated with several acute subjective effects measures, including total scores on MEQ, and individual factors on CEQ and 11D-ASC. <h4>Conclusions: </h4> and Relevance: Repeated psilocybin administration is tolerable and potentially efficacious in reducing OCD symptoms. These results support further investigation of multi dose psilocybin protocols as a viable therapeutic approach. <h4>Trial Registration</h4> ClinicalTrials.gov Identifier NCT05546658 <h4>Key points</h4> Psilocybin was generally safe and tolerated across repeated dosing Psilocybin produced reductions in OCD symptom severity Quality of the psychedelic experience was correlated with therapeutic benefit
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