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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
Non-consumption of SSRIs for at least 8 weeks at the time of randomization
Primary DSM-5 diagnosis of OCD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 48 hours post-drug, weeks: 1, 2, 4, 12 post-drug
Awards & highlights
Study Summary
This trial looks at whether psilocybin, a compound found in some mushrooms, can help relieve symptoms of OCD. They will also study what effects psilocybin has on the brain.
Who is the study for?
This trial is for adults with Obsessive-Compulsive Disorder (OCD) who have tried at least one standard treatment without success. Participants must not be taking certain psychiatric medications, including SSRIs, and should have a support person available. They cannot join if they have a history of certain mental disorders, recent psychedelic use, or conditions that make MRI scans unsafe.Check my eligibility
What is being tested?
The study tests the impact of psilocybin on OCD symptoms compared to niacin as a placebo. It's double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo during the trial. The goal is to understand how psilocybin might affect brain function related to OCD.See study design
What are the potential side effects?
Psilocybin can cause various side effects such as changes in sensory perception, mood swings, dizziness, nausea, and headaches. In some cases it may lead to anxiety or panic reactions especially in individuals predisposed to these conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't taken SSRIs for at least 8 weeks.
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I have been diagnosed with OCD.
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I stopped taking my SSRI medication long enough for it to be out of my system.
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I have tried at least one standard OCD treatment without success.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 48 hours post-drug, weeks: 4, 8, 12 post-drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 48 hours post-drug, weeks: 4, 8, 12 post-drug
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in severity of OCD symptoms, measured by Acute Yale-Brown Obsessive-Compulsive Scale (A-YBOCS)
Changes in severity of OCD symptoms, measured by Visual Analog Scale (VAS) for OCD symptoms
Changes in severity of OCD symptoms, which will be measured by The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The Measure will be collected at baseline and 48 hours, assessing change from baseline at 48 hours.
+1 moreSecondary outcome measures
5-Dimension - Altered States of Consciousness (5D-ASC)
Challenging Experience Questionnaire (CEQ)
Change in interpersonal connectedness, which will be measured by The Inclusion of Others in Self Scale (IOS).
+29 moreOther outcome measures
Changes in Immunological function.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PsilocybinExperimental Treatment1 Intervention
Psilocybin (0.25mg/kg)
Group II: NiacinPlacebo Group1 Intervention
Niacin (250mg)
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,245 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,951 Patients Enrolled for Obsessive-Compulsive Disorder
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,788 Total Patients Enrolled
10 Trials studying Obsessive-Compulsive Disorder
561 Patients Enrolled for Obsessive-Compulsive Disorder
Heffter Research InstituteOTHER
13 Previous Clinical Trials
468 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a score of 18 or more on the YBOCS evaluation, which measures the severity of obsessive-compulsive disorder symptoms.I haven't taken SSRIs for at least 8 weeks.I am willing to stop taking psychiatric and certain other medications during the study.You have Obsessive-Compulsive Personality Disorder (OCPD) or Borderline Personality Disorder (BPD).I do not have uncontrolled diabetes, high blood pressure, heart issues, or a history of seizures or severe headaches.I will not start new psychiatric meds during the study without informing the team.The study participant must be willing to sign a medical release that allows the investigators to communicate directly with the study participant's therapist and doctors to confirm any medication and/or medical historyI must be medically approved to drive or have arranged a ride after my session.The participant must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the Clinical Investigators in the event of the participant becoming suicidal.You are currently feeling extremely sad or hopeless and have thoughts of wanting to harm yourself.You have autism.Your score on the Y-BOCS scale is 19 or higher, which indicates significant symptoms of obsessive-compulsive disorder.You have a problem with drugs or substances, except for mild alcohol use.You have used drugs that alter your perception and thinking, like psychedelics, in the past year.The DSM-5 diagnosis of OCD is established by a trained clinician interview and confirmed by Mini International Neuropsychiatric Interview MINI (edition 7).I have had a head injury where I was unconscious for over 30 minutes.I am willing to follow all study requirements, including staying in the hospital, undergoing tests, and reporting my health status.I have been diagnosed with OCD.I have someone who can be contacted by the study team in emergencies and can take me home after hospital stays.My Tourette syndrome has not improved.I have tried at least one standard OCD treatment without success.I stopped taking my SSRI medication long enough for it to be out of my system.You or someone in your close family has had schizophrenia, bipolar disorder, or severe depression with hallucinations.You cannot take any psychiatric medication while participating in the study.I have tried at least one standard OCD treatment without success.The person can understand what the study is, what is involved, the risks and benefits and they are able to consent to taking part in the study by giving written consent.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are associated with a 0.25mg/kg dosage of Psilocybin?
"The safety of Psilocybin (0.25mg/kg) is rated a 1, as this clinical trial falls into the Phase 1 stage, meaning there is limited data confirming its efficacy and minimal evidence to suggest it is safe for human consumption."
Answered by AI
How many participants are being accepted into this experiment?
"Affirmative. According to the clinicaltrials.gov database, this trial is actively recruiting participants and has been since November 13th 2018; its status was last updated on December 7th 2021. Currently, 30 patients are being sought out over 1 location."
Answered by AI
Who meets the criteria to join this medical experiment?
"In order to be eligible for this clinical trial, candidates must have an OCD diagnosis and fall between 21-65 years old. Approximately 30 individuals are needed in total."
Answered by AI
Is the enrollment criterion for this research trial restricted to individuals aged 25 or younger?
"The entry qualifications for this medical trial stipulate that potential participants must be 21 or older, while the upper age limit is 65."
Answered by AI
What medical conditions has research shown Psilocybin (0.25mg/kg) to be most effective in treating?
"Psilocybin (0.25mg/kg) is a reliable option for treating high cardiovascular risk and other issues like dyslipidemia, pancreatitis risks, and lipidemia."
Answered by AI
Are there vacancies for eligible participants in this clinical trial?
"Clinicaltrials.gov records indicate that this medical trial is open to recruitment and was initially posted on November 13th 2018, with the latest update occurring on December 7th 2021."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
New York
Connecticut
Other
How old are they?
< 18
18 - 65
What site did they apply to?
Connecticut Mental Health Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+
1
Why did patients apply to this trial?
Promise of psylocibin in OCD. The quality of my life is very poor. I’ve tried CBT/ERP, medication without significant relief of symptoms.
PatientReceived no prior treatments
I was diagnosed with OCD over 12 years ago. No medications have worked. I am looking for treatment.
PatientReceived 1 prior treatment
I believe this would work for me better then anything else I have ever tried including which mother of my life was nothing.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
What does it entail in its entirety? How long and often will I need to travel to New Haven?
PatientReceived 2+ prior treatments
I have had panic attacks; severe as a teenager, infrequent as an adult. If one should experience such an experience, what safeguards are in place to mitigate severity, if panic occurs, during trial?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Connecticut Mental Health Center: < 24 hours
Average response time
- < 2 Days
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