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Psychedelic

Psilocybin for Obsessive-Compulsive Disorder

Phase 1

Recruiting

Led By Benjamin Kelmendi, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not be on psychotropic medications for OCD or comorbid psychiatric conditions for at least 8 weeks at the time of randomization, and agree to refrain from taking or starting any psychiatric medications until after 4 weeks post-second dose

Failed at least one medication and/or therapy trial of standard care treatment for OCD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition

Awards & highlights

Study Summary

This trial will study the effects of psilocybin on obsessive-compulsive disorder and assess psychological mechanisms that may explain any therapeutic effects.

Who is the study for?

This trial is for adults with a primary diagnosis of OCD, who have tried at least one standard treatment without success. Participants must be fluent in English, able to take oral pills, not on psychotropic medications or psychotherapy for 8 weeks prior to the study and agree not to start any during the study. They should provide an emergency contact and commit to all procedures including lifestyle changes.Check my eligibility

What is being tested?

The trial tests how repeated doses of psilocybin affect OCD symptoms compared to a waitlist group. It's randomized and includes blinded ratings. The goal is also to understand psychological processes that might explain psilocybin's potential benefits in treating OCD.See study design

What are the potential side effects?

While specific side effects are not listed here, psilocybin can potentially cause changes in perception, mood swings, dizziness, nausea, confusion or disorientation during the time it affects the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't taken any psychiatric drugs for OCD or other mental health issues for 8 weeks.

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I have tried at least one standard OCD treatment without success.

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My OCD is severe, with a high Y-BOCS-II score.

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I can swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition

This trial's timeline: 3 weeks for screening, Varies for treatment, and every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Severity Scale total score from baseline at 4 days post-second dose

Secondary outcome measures

Challenging Experience Questionnaire (CEQ)

Change in Acceptance and Action Questionnaire for Obsessions and Compulsions (AAQ-OC) total score from baseline at 4 days post-second dose

Change in Alcohol Use Disorders Identification Test (AUDIT) total score from baseline at 4 weeks post-second dose

+26 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Suicidal Ideation

Oropharyngeal pain

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Restlessness

Fungal infection

Pyrexia

Hypoesthesia

Oedema

Vomiting

Rhinorrhea

Musculoskeletal pain

Peripheral swelling

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate TreatmentExperimental Treatment1 Intervention

Participants randomized to this condition will receive treatment immediately, facilitated by two study staff members, and which consists of two preparatory sessions, followed by the first dosing session and two integration sessions, then the second dosing session and two integration sessions. This is followed by follow-up and long-term follow-up visits up to 12 months post-second dose.

Group II: Waitlist Control/Delayed TreatmentActive Control1 Intervention

Participants randomized to this condition will first enter a waitlist phase that lasts for 7 weeks, after which rater unblinding will occur, and participants will be rescreened. If participants remain eligible at this time, they will begin their treatment phase. During their treatment phase, participants in this condition will receive the same treatment as described for participants in the immediate treatment group. This is followed by follow-up and long-term follow-up visits up to 12 months post-second dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~730

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Steven & Alexandra Cohen FoundationOTHER

6 Previous Clinical Trials

194 Total Patients Enrolled

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,736,498 Total Patients Enrolled

10 Trials studying Obsessive-Compulsive Disorder

561 Patients Enrolled for Obsessive-Compulsive Disorder

Benjamin Kelmendi, MDPrincipal InvestigatorYale University

2 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Obsessive-Compulsive Disorder

30 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05370911 — Phase 1

Obsessive-Compulsive Disorder Research Study Groups: Immediate Treatment, Waitlist Control/Delayed Treatment

Obsessive-Compulsive Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05370911 — Phase 1

Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370911 — Phase 1

Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05370911 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks accompany the utilization of Psilocybin?

"Power has assessed the safety of Psilocybin to be a 1, as this is just a Phase 1 trial and there has been limited evidence supporting its efficacy and safety."

Answered by AI

Is this trial suitable for geriatric individuals?

"Qualified participants of this clinical trial must be between 18-65 years old, with 23 trials for those under the age limit and 67 trials available to people over 65."

Answered by AI

Are there still opportunities for participants to take part in this experiment?

"Clinicaltrials.gov has registered this trial as inactive; it was initially posted on February 1st, 2023 and its most recent edit took place on November 21st 2022. Despite the fact that this clinical study is not accepting participants presently, there are 114 other research initiatives which currently require volunteers."

Answered by AI

Under what conditions can individuals participate in this research?

"This clinical trial is seeking 30 participants between 18 and 65 years old who have been diagnosed with obsessive-compulsive disorder. To apply, candidates must meet several criteria: they must accept all study procedures, possess a primary DSM-5 diagnosis of OCD (with Y-BOCS-II score greater than 26), be unresponsive to standard care treatment for OCD, provide an adult contact available in the event of emergency or transportation purposes, demonstrate fluency in English language, grant permission for investigators to communicate directly about their medication/psychotherapy histories; consent to lifestyle modifications related to the test intervention as well as refrain from taking any psychiatric medications 4"

Answered by AI