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Psychedelic

Psilocybin for OCD

Phase < 1
Recruiting
Led By David B Yaden, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have at least one prior attempt at treatment, either ERP or pharmacotherapy
Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (CBC, CMP, urine beta-HCG, urine toxicology screen)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post session 2
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test if magic mushrooms are safe & effective for people with OCD. A proof of concept for larger trials to come.

Who is the study for?
This trial is for adults with Obsessive Compulsive Disorder (OCD) who have tried treatment before. Participants should not have used hallucinogens often, be at low risk of suicide, and agree to avoid certain medications and substances before sessions. Women must use effective birth control if applicable.Check my eligibility
What is being tested?
The study tests the safety and potential effectiveness of psilocybin as a treatment for OCD. It's an early-stage trial to see if larger studies are warranted, focusing on how this intervention might affect cognitive processes and brain function in OCD patients.See study design
What are the potential side effects?
While not explicitly listed here, psilocybin can cause psychological effects like altered perception, mood changes, disorientation or confusion which typically resolve after the drug wears off but can be distressing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried at least one treatment, like medication or therapy.
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I am medically stable based on recent health screenings and tests.
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I have been diagnosed with OCD for over a year.
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I have tried at least one treatment, like medication or therapy.
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I have been diagnosed with OCD and have had it for at least a year.
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I have tried at least one treatment, like medication or therapy.
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I haven't taken antidepressants for a period equal to five half-lives before joining the study.
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I am using effective birth control during the study.
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I have been in stable psychotherapy for at least 2 months.
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I am medically stable based on recent health screenings and tests.
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I agree not to take medications like Viagra within 72 hours of each treatment.
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I agree not to take any non-prescribed drugs or supplements before drug sessions, except for approved exceptions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post session 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post session 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mental Depression
Change in The Yale Brown Obsessive Compulsive Scale (Y-BOCS) score
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
+1 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
44%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Urinary incontinence
2%
Illusion
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate PsilocybinExperimental Treatment1 Intervention
This arm will receive two sessions of psilocybin first (20mg in first session and then, if well tolerated, 30mg).
Group II: Delayed PsilocybinActive Control1 Intervention
Waitlist control. This arm will receive psilocybin after the waiting period is over (20mg in first session and then, if well tolerated, 30mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,225 Previous Clinical Trials
14,811,769 Total Patients Enrolled
David B Yaden, PhDPrincipal InvestigatorJohns Hopkins University
Roland R Griffiths, PhDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
140 Total Patients Enrolled

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05546658 — Phase < 1
Obsessive-Compulsive Disorder Research Study Groups: Immediate Psilocybin, Delayed Psilocybin
Obsessive-Compulsive Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05546658 — Phase < 1
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546658 — Phase < 1
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05546658 — Phase < 1

Frequently Asked Questions

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

Are there any remaining vacancies in this research protocol?

"Affirmative. According to clinicaltrials.gov, this medical experiment is in the midst of recruiting 30 patients from one location. The trial was first posted on November 28th 2022 and has been updated recently on that same day."

Answered by AI

Is eligibility for this experiment open to me?

"This clinical trial is recruiting 30 individuals with Obsessive-Compulsive Disorder (OCD) between the ages of twenty-one and seventy. To be eligible, patients must possess DSM-5 criteria for OCD as well as a Y-BOCS score of 18 or more; they should have experienced at least one prior attempt at treatment - either Exposure Response Prevention (ERP) or pharmacotherapy. Furthermore, candidates seeking inclusion in this study must meet medical stability standards that involve interviews, questionnaires, physical examinations and laboratory tests. Additionally, those accepted into the program are required to consume approximately the same amount of caffeine on session days unless"

Answered by AI

How many participants are being welcomed into this research project?

"Affirmative. According to the data on clinicaltrials.gov, this medical experiment began recruiting participants on November 28th 2022 and is still accepting applications. The researchers are attempting to enlist 30 people from 1 trial site."

Answered by AI

Does this experimental procedure accept participants aged below 75 years?

"To participate in this clinical trial, prospective candidates must be between 21 and 70 years of age. There are 258 studies for those younger than 18 and 660 trials focusing on people over 65."

Answered by AI

Who else is applying?

What state do they live in?
New York
Illinois
California
Other
What site did they apply to?
Johns Hopkins University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+

What questions have other patients asked about this trial?

Is this a paid study? How many appointments are there? How long do screening visits take? How does compensation work?
PatientReceived no prior treatments

Why did patients apply to this trial?

Because I’m still dealing with ocd despite many years of therapy, including talk and medication.
PatientReceived 1 prior treatment
I have been seeking treatment for OCD for a long time and nothing I tried thus far has relieved my symptoms.
PatientReceived 1 prior treatment
I have tried many forms of treatment and still struggle (therapy, medication, alternative medication, EMDR, etc).
PatientReceived no prior treatments
I am health conscious about my varieties of anxiety disorders. I also suffer from panic anxiety, generalized anxiety and depression.
PatientReceived 2+ prior treatments
I have been following a drug treatment with three different drugs for almost two years and none of them have and none of them have shown a development in the improvement of my symptoms. Also, during the same amount of time in which I have been taking these drugs my psychiatrist has been treating me with psychodynamic therapy with no without major advances.
PatientReceived 2+ prior treatments
~16 spots leftby Sep 2025