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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
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.
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
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 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%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
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
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
~730
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,823,134 Total Patients Enrolled
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
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
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