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

Terence H. W. Ching, Stephen A. Kichuk, Giuliana DePalmer, Christopher Pittenger, Benjamin Kelmendi

October 5, 2022 preprint DOI: 10.31234/osf.io/85s9p (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Double-blind, placebo-controlled study
Population Eligible participants with obsessive-compulsive disorder (OCD)
Intervention Psilocybin
Dose 0.25 mg/kg
Topics Anxiety Psilocybin
Keywords Dosing Obsessive compulsive Context archaeology Exposure therapy Psychotherapist Clinical psychology Pharmacology Hallucinogen
Citations 5
Key points The study is testing the safety and efficacy of a single 0.25 mg/kg dose of psilocybin with non-directive support for OCD.

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.

Comparable studies

Other randomized controlled trials on psilocybin for anxiety, most cited first.

Study Year Design Participants
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Hallucinogen-naïve adults reporting regular participation in religious or spiritual... 2006 Double-blind study n = 36
Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Adults with advanced-stage cancer and anxiety 2010 Double-blind, placebo-controlled study n = 12
Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies Healthy human subjects 2010 Pooled analysis of double-blind placebo-controlled experimental studies n = 110

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