Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study.

Completed · Phase 1 · Has a placebo group

Conditions studied: Obsessive-Compulsive Disorder

In brief

This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate psilocybin's purported therapeutic effects on OCD.

Key facts

Study ID

NCT03356483

Run by

Yale University

People needed

31

Starts

2018-11-13

Expected to finish

2024-07-25

Last updated by the study team

2024-11-20

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary DSM-5 diagnosis of OCD
• Y-BOCS score of 19 or greater
• Failure of at least one trial of standard care treatment (medication and/or psychotherapy [CBT/ERP]) for OCD
• English proficiency and fluency, and ability to understand the consent process and provide written informed consent
• Willingness to sign a medical release for direct communication between research staff and external provider(s) about the participant's treatment and medical histories
• Non-consumption of SSRIs for at least 8 weeks at the time of randomization
• Willingness to refrain from psychiatric medications (e.g., antidepressants, first- and second-generation antipsychotics, mood stabilizers) during the study period, as well as certain other medications (e.g., anti-seizure medications, cardiovascular medications, and aldomet specifically) during the day of dosing
• Willingness to abstain from THC-containing products for study duration. A negative urinary drug screen is also required at baseline and the day of dosing.
• A negative urinary pregnancy screen at study entry and day of dosing if of childbearing potential, and willingness to use adequate birth control for study duration
• Having a contact person who is willing and able to be reached by the study team in the event of an emergency/crisis, and who is able to transport the participant home at the end of the inpatient stay/dosing week
• Willingness to commit to all study procedures and visits, including inpatient stay, assessments and self-reports, neuroimaging, and being medically cleared to be discharged and transported home at the end of the dosing week

You may not qualify if…

• Personal or immediate family history of schizophrenia spectrum and other psychotic disorders, bipolar I or II disorder, or major depressive disorder with psychotic features
• Active suicidal intent
• Unremitted Tourette syndrome
• Autism spectrum disorder
• OCPD or BPD
• Current substance use disorder (except mild alcohol use disorder)
• Unstable neurological or medical condition(s) that may render study procedures unsafe, including poorly managed diabetes, hypertension, or cardiovascular conditions, or history of seizure(s) or chronic/severe headaches
• Any history of head injury with loss of consciousness for more than 30 minutes
• Any contraindications to undergoing an MRI scan, including having metal implants or metal fragments in the body
• Any use of psychedelic substances within the prior 12 months

Where it is running

• Connecticut Mental Health Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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