Yale Program for Psychedelic Science (YPPS) Manual for Psilocybin-OCD Session Monitors for Protocol HIC: 2000020355

A single 0.25 mg/kg dose of psilocybin, given with non-directive psychological support in a controlled clinical setting, is being tested for safety and efficacy in treating obsessive-compulsive disorder. Monitors accompany participants before, during, and after dosing to prepare them, ensure safety, and provide an unstructured context for processing the experience. Although no formal therapy is delivered, the supportive presence of monitors may be experienced as therapeutic. This manual outlines monitor activities across the three phases of the dosing session.

Study at a glance

Abstract

The Yale Program for Psychedelic Science (YPPS) is testing the safety and efficacy of psilocybin, administered in conjunction with non-directive psychological support, as a treatment for certain neurological and psychiatric conditions. The study, HIC: 200020355 (Neural correlates of the effects of psilocybin in obsessive-compulsive disorder: A double-blind, placebo-controlled study), will explore the safety and efficacy of a single 0.25 mg/kg dose of psilocybin, administered in a supportive clinical environment, to eligible participants with obsessive-compulsive disorder (OCD). Monitors meet with each participant before, during, and after the dosing session. Monitors do not provide any structured therapy, but rather help participants prepare for the experience of psilocybin dosing, ensure psychological safety during dosing, and provide participants with an unstructured context in which to process their experience during and after dosing at defined timepoints. In doing so, while no structured therapy is provided, the presence and accompaniment by monitors throughout all study sessions may be experienced as supportive or even therapeutic by participants. This manual provides background and details for Monitors on the activities that are required at three points – before, during, and after the dosing session.