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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post session 2
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month post session 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post session 2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mental Depression
Change in The Yale Brown Obsessive Compulsive Scale (Y-BOCS) score
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
+1 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
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
~530
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,601 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
30 Patients Enrolled for Obsessive-Compulsive Disorder
David B Yaden, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
40 Total Patients Enrolled
Roland R Griffiths, PhDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot go without nicotine for 8-10 hours.I am not pregnant or nursing.I am a woman able to have children and am not using effective birth control.I have tried at least one treatment before, like medication or therapy.I haven't taken antidepressants for their full withdrawal period before starting the study.I am using effective birth control during the study.I have been diagnosed with OCD and have had it for at least a year.I agree not to consume alcohol or psychoactive drugs 24 hours before each treatment, except for caffeine and nicotine.I have Type 1 diabetes.I am medically stable based on recent health screenings and tests.I suffer from severe migraines or similar intense headaches.I have a close family member with schizophrenia, bipolar I, or another psychotic disorder.I agree not to take any erectile dysfunction medication 72 hours before each treatment.I am not currently taking any daily psychoactive or serotonin-affecting medications, or MAOIs.I have epilepsy with a history of seizures.I have been in stable psychotherapy for at least 2 months.I agree not to take any non-prescribed drugs or supplements before each drug session, except for approved exceptions.I have not had serious heart issues or strokes in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Psilocybin
- Group 2: Delayed Psilocybin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT05546658 — Phase < 1