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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
Willingness to refrain from psychiatric medications (e.g., antidepressants, first- and second-generation antipsychotics, mood stabilizers) during the study period, as well as certain other medications (e.g., anti-seizure medications, cardiovascular medications, and aldomet specifically) during the day of dosing
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 below
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I haven't taken SSRIs for at least 8 weeks.
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I am willing to stop taking psychiatric and certain other medications during the study.
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I will not start new psychiatric meds during the study without informing the team.
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I must be medically approved to drive or have arranged a ride after my session.
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I am willing to follow all study requirements, including staying in the hospital, undergoing tests, and reporting my health status.
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I have been diagnosed with OCD.
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I have someone who can be contacted by the study team in emergencies and can take me home after hospital stays.
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I have tried at least one standard OCD treatment without success.
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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 weeks
Treatment ~ Varies
Follow Up ~day of drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of drug administration for reporting.

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 more
Secondary 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 more
Other 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
2,781 Previous Clinical Trials
2,674,948 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,951 Patients Enrolled for Obsessive-Compulsive Disorder
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
Heffter Research InstituteOTHER
13 Previous Clinical Trials
468 Total Patients Enrolled

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT03356483 — Phase 1

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

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

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

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Connecticut Mental Health Center: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
~2 spots leftby Aug 2024