Psilocybin for Treatment of OCD-2

This randomised, double-masked Phase I/II trial (n=20) will study the safety, tolerability, and efficacy of psilocybin (10mg vs 30mg) across four sessions for the treatment of obsessive-compulsive disorder (OCD).

Led by Dr Francisco Moreno at the University of Arizona, this 12-week study will recruit 20 adults with moderate to severe OCD who are not currently using psychiatric medications.

Participants will be randomly assigned to receive either a low (10mg) or high (30mg) oral dose of psilocybin during four sessions, spaced three weeks apart. The study will assess changes in OCD severity, overall functioning, and quality of life using clinical scales such as the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Additionally, brain imaging (fMRI) and EEG will be used to explore neurological mechanisms of psilocybin’s effects. The trial also aims to examine whether the altered states of consciousness induced by psilocybin play a role in therapeutic outcomes. Safety precautions are in place due to psilocybin’s potential to induce intense psychological experiences, particularly at the higher dose. This trial hopes to lay the groundwork for a larger-scale study by identifying effective and tolerable dosing strategies.

Trial Details

Previous research indicates that psilocybin, a drug that changes activity in brain areas believed to be involved in obsessive-compulsive disorder (OCD), might improve treatment for, and improve lives of, people diagnosed with OCD. The investigators propose to study 20 patients with symptomatic OCD who are not taking mind altering medications or street drugs, to participate in a 12 week study. Participants will be assigned (by luck of the draw) to take low or high dose psilocybin in four dosing sessions separated by 3 weeks. Measurements for the severity of OCD, ability to function, perception of quality of life, safety and tolerability will be measured at baseline prior to drug administration, during the dosing periods, and at the end of study. Other measurements will include brain imaging via fMRI and brain tracing via electroencephalogram (EEG). The investigators believe that during medically supervised dosing sessions, both doses of psilocybin will be safe and well tolerated, and will reduce OCD symptoms. Because psilocybin is a potent drug and especially at the higher dose may induce altered states of consciousness, a thoughtfully implemented procedure for participant safety is in place. Information will be obtained to explore the effects of altered states of consciousness in the outcome of treatment and to find the mechanism of benefit.

Trial Number NCT06992999

Data attribution

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