Psychedelic
Psilocybin for Obsessive-Compulsive Disorder
Connecticut Mental Health Center, New Haven, CT
PsilocybinPhase 1RecruitingLed by Benjamin Kelmendi, MDResearch Sponsored by Yale UniversityEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to orally ingest pills for psilocybin dosing visits.
Ability to orally ingest pills for psilocybin dosing visits
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upevery study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will study the effects of psilocybin on obsessive-compulsive disorder and assess psychological mechanisms that may explain any therapeutic effects.
Eligible Conditions
- Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are able to orally ingest pills for psilocybin dosing visits.
Select...
You are able to swallow pills during the visits where you will be given psilocybin.
Select...
You have tried at least one medication or therapy for OCD but it didn't work for you.
Select...
You have been diagnosed with OCD and your Y-BOCS-II score is 26 or higher during the initial evaluation.
Select...
You have a primary diagnosis of OCD, with a Y-BOCS-II score of 26 or greater at screening.
Select...
You have already tried at least one medication or therapy for OCD and it didn't work for you.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every study visit through study completion, an average of 12 months and 3 weeks for immediate treatment condition, and an average of 12 months and 10 weeks for waitlist condition
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Severity Scale total score from baseline at 4 days post-second dose
Secondary outcome measures
Challenging Experience Questionnaire (CEQ)
Change in Acceptance and Action Questionnaire for Obsessions and Compulsions (AAQ-OC) total score from baseline at 4 days post-second dose
Change in Alcohol Use Disorders Identification Test (AUDIT) total score from baseline at 4 weeks post-second dose
+26 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT0206129344%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Depressed mood
6%
Insomnia
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%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Biopsy cervix
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%
Illusion
2%
Urinary incontinence
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 TreatmentExperimental Treatment1 Intervention
Participants randomized to this condition will receive treatment immediately, facilitated by two study staff members, and which consists of two preparatory sessions, followed by the first dosing session and two integration sessions, then the second dosing session and two integration sessions. This is followed by follow-up and long-term follow-up visits up to 12 months post-second dose.
Group II: Waitlist Control/Delayed TreatmentActive Control1 Intervention
Participants randomized to this condition will first enter a waitlist phase that lasts for 7 weeks, after which rater unblinding will occur, and participants will be rescreened. If participants remain eligible at this time, they will begin their treatment phase. During their treatment phase, participants in this condition will receive the same treatment as described for participants in the immediate treatment group. This is followed by follow-up and long-term follow-up visits up to 12 months post-second dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~710
Find a site
Who is running the clinical trial?
Steven & Alexandra Cohen FoundationUNKNOWN
3 Previous Clinical Trials
78 Total Patients Enrolled
Yale UniversityLead Sponsor
1,760 Previous Clinical Trials
2,689,880 Total Patients Enrolled
10 Trials studying Obsessive-Compulsive Disorder
561 Patients Enrolled for Obsessive-Compulsive Disorder
Benjamin Kelmendi, MDPrincipal Investigator
Yale University2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
30 Patients Enrolled for Obsessive-Compulsive Disorder
Terence Ching, PhDPrincipal Investigator
Yale UniversityChristopher Pittenger, MD, PhDStudy Director
Yale University2 Previous Clinical Trials
130 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
130 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks accompany the utilization of Psilocybin?
"Power has assessed the safety of Psilocybin to be a 1, as this is just a Phase 1 trial and there has been limited evidence supporting its efficacy and safety."
Answered by AI
Is this trial suitable for geriatric individuals?
"Qualified participants of this clinical trial must be between 18-65 years old, with 23 trials for those under the age limit and 67 trials available to people over 65."
Answered by AI
Are there still opportunities for participants to take part in this experiment?
"Clinicaltrials.gov has registered this trial as inactive; it was initially posted on February 1st, 2023 and its most recent edit took place on November 21st 2022. Despite the fact that this clinical study is not accepting participants presently, there are 114 other research initiatives which currently require volunteers."
Answered by AI
Under what conditions can individuals participate in this research?
"This clinical trial is seeking 30 participants between 18 and 65 years old who have been diagnosed with obsessive-compulsive disorder. To apply, candidates must meet several criteria: they must accept all study procedures, possess a primary DSM-5 diagnosis of OCD (with Y-BOCS-II score greater than 26), be unresponsive to standard care treatment for OCD, provide an adult contact available in the event of emergency or transportation purposes, demonstrate fluency in English language, grant permission for investigators to communicate directly about their medication/psychotherapy histories; consent to lifestyle modifications related to the test intervention as well as refrain from taking any psychiatric medications 4"
Answered by AI
Who else is applying?
What state do they live in?
California
Illinois
Connecticut
Other
How old are they?
65+
< 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
1
0
3+
Why did patients apply to this trial?
I want to see what OCD free me would be like. I have tried many medications for ocd and nothing helps.
Patient
I have anxiety and ocd for years and it’s only getting worse. I’ve tried 2 SSRIs and therapy and have only found temporary relief in symptoms so far.
Patient
Been wanting to get into a study or whatever involving psychedelics for quite some time.
Patient
What questions have other patients asked about this trial?
How long would visits take? How long do the trials take? When does it start? How long is it ? How many does are administered ?
Patient
How responsive is this trial?
Most responsive sites:
- Connecticut Mental Health Center: < 48 hours
Average response time
- < 2 Days
Typically responds via
Email
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