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CompletedPhase 1

Psilocybin for Treatment of Obsessive Compulsive Disorder

NCT03300947 · PSILOCD · University of Arizona

Closed to entry
Status
Not accepting participants
Phase 1
Phase
15
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and will investigate the mechanisms by which it works.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Treatment-phase effects on Obsessive-Compulsive symptom severity

    Measured over weekly Y-BOCS rating prior to ingestion of study drug on Week 1 through 8, and week 9 (follow up week 1)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Have moderate to severe OCD (DSM-5) after diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID-R). * Failed at least one adequate attempted routine care treatment. * Considered safe for independent living Exclusion Criteria: * Concurrent psychosis, active substance use disorder, or a personal history of psychosis. * Medical illness based on physical examination and routine blood testing that may complicate cardiovascular safety or drug metabolism or excretion, such as uncontrolled hypertension, severe cardiac disease, or kidney or liver failure. * Unstable Chronic Obstructive Pulmonary Disease (COPD) or severe sleep apnea * Psychiatric comorbidity that may represent an acute risk to their own or others' safety. * Subjects may not be using antidepressant medication for OCD for at least two weeks before receiving study drug, and they cannot require any sedative, narcotic, or neuroleptic medications on a regular basis. Any of these medications they have taken should have been stopped long enough in the past to allow for their elimination and safe withdrawal prior to starting administration of the study drug. The specific time required will be dependent on the medication the patient was previously receiving. * Women who are pregnant, breastfeeding, or unwilling/unable to practice medically acceptable birth control during the study. * Allergy to lorazepam.

Where

1 study site

FacilityCityRegionCountry
University of ArizonaTucsonArizonaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03300947 on ClinicalTrials.gov →

Last updated in the registry 2024-08-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits