RECRUITING

Effects of Repeated Psilocybin Dosing in OCD

Conditions

Obsessive-Compulsive Disorder Psilocybin

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to investigate the effects of repeated dosing of oral psilocybin on obsessive-compulsive disorder (OCD) symptomatology in a randomized, waitlist-controlled design with blinded independent ratings, and assess psychological mechanisms that may mediate psilocybin's therapeutic effects on OCD.

Official Title

Effects of Repeated Dosing of Psilocybin on Obsessive-Compulsive Disorder: A Randomized, Waitlist-Controlled Study

Quick Facts

Study Start:2023-07-20

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05370911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Primary DSM-5 diagnosis of OCD, with Y-BOCS-II score of 26 or greater at screening 2. Failed at least one medication and/or therapy trial of standard care treatment for OCD 3. English fluency 4. Agree to sign a medical release for investigators to communicate directly with participants' providers to confirm medication and psychotherapy histories or arrange contingencies in event of crises. 5. Agree to provide an adult contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the PI and/or study personnel in the event of an emergency, and who can provide transportation for study visits and independently comment on any changes in the participant's mood or behavior after each administration of psilocybin. 6. Agree to commit to all study procedures. 7. Ability to orally ingest pills for psilocybin dosing visits. 8. Agree to adhere to lifestyle and medication modifications. 9. Must not be on psychotropic medications for OCD or comorbid psychiatric conditions for at least 8 weeks at the time of randomization, and agree to refrain from taking or starting any psychiatric medications until after 4 weeks post-second dose. 10. Must not be in current psychotherapy (CBT or ERP) and must not start new course of psychotherapy (CBT or ERP) for OCD or comorbid psychiatric conditions until after 4 weeks post-second dose. 11. If participant is of childbearing potential, must have a negative pregnancy test at study entry and prior to each dosing session. 12. If participant is of childbearing potential, agree to use adequate birth control and not attempt to become pregnant during study up to 4 weeks post-second dose.	1. Personal or immediate (first-degree relative) family history of formally diagnosed schizophrenia or other psychotic disorders, or bipolar I/II disorder 2. Lack of knowledge about biological families' medical history, due to adoption or other circumstance 3. Active suicidal intent or suicidal or non-suicidal self-injurious behaviors 4. Unremitted Tourette syndrome 5. Lifetime diagnosis of autism spectrum disorder 6. Current substance use disorder (except for mild alcohol use disorder) 7. Any neurological condition, including history of seizure(s) or chronic/severe headaches 8. Any history of head injury with loss of consciousness for more than 30 min 9. Any use of classic psychedelic substances within the prior 12 months 10. Unwillingness to abstain from use of classic psychedelics outside of the study up to 4 weeks post-second dose. 11. Use of tobacco products or a THC-containing product more than 2 times per week on average over the past 30 days at screening. 12. Unwilingness or inability to abstain from use of tobacco or THC-containing products from 1 week prior to randomization up to 4 weeks post-second dose. 13. Positive urine drug test for any prohibited substance at screening or days of dosing, or positive breathalyzer test for alcohol on days of dosing 14. Unwillingness or inability to abstain from alcohol use at least 24 hours prior to the days of dosing, up to 24 hours after each dosing day (or corresponding intervals for waitlist group). 15. Any medical conditions that may render study procedures unsafe, including hypertension, history of cardiovascular disease, moderate-to-severe hepatic or renal impairment, diabetes, and hypo- or hyperthyroidism.

Inclusion Criteria

Exclusion Criteria

1. Primary DSM-5 diagnosis of OCD, with Y-BOCS-II score of 26 or greater at screening
2. Failed at least one medication and/or therapy trial of standard care treatment for OCD
3. English fluency
4. Agree to sign a medical release for investigators to communicate directly with participants' providers to confirm medication and psychotherapy histories or arrange contingencies in event of crises.
5. Agree to provide an adult contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the PI and/or study personnel in the event of an emergency, and who can provide transportation for study visits and independently comment on any changes in the participant's mood or behavior after each administration of psilocybin.
6. Agree to commit to all study procedures.
7. Ability to orally ingest pills for psilocybin dosing visits.
8. Agree to adhere to lifestyle and medication modifications.
9. Must not be on psychotropic medications for OCD or comorbid psychiatric conditions for at least 8 weeks at the time of randomization, and agree to refrain from taking or starting any psychiatric medications until after 4 weeks post-second dose.
10. Must not be in current psychotherapy (CBT or ERP) and must not start new course of psychotherapy (CBT or ERP) for OCD or comorbid psychiatric conditions until after 4 weeks post-second dose.
11. If participant is of childbearing potential, must have a negative pregnancy test at study entry and prior to each dosing session.
12. If participant is of childbearing potential, agree to use adequate birth control and not attempt to become pregnant during study up to 4 weeks post-second dose.

1. Personal or immediate (first-degree relative) family history of formally diagnosed schizophrenia or other psychotic disorders, or bipolar I/II disorder
2. Lack of knowledge about biological families' medical history, due to adoption or other circumstance
3. Active suicidal intent or suicidal or non-suicidal self-injurious behaviors
4. Unremitted Tourette syndrome
5. Lifetime diagnosis of autism spectrum disorder
6. Current substance use disorder (except for mild alcohol use disorder)
7. Any neurological condition, including history of seizure(s) or chronic/severe headaches
8. Any history of head injury with loss of consciousness for more than 30 min
9. Any use of classic psychedelic substances within the prior 12 months
10. Unwillingness to abstain from use of classic psychedelics outside of the study up to 4 weeks post-second dose.
11. Use of tobacco products or a THC-containing product more than 2 times per week on average over the past 30 days at screening.
12. Unwilingness or inability to abstain from use of tobacco or THC-containing products from 1 week prior to randomization up to 4 weeks post-second dose.
13. Positive urine drug test for any prohibited substance at screening or days of dosing, or positive breathalyzer test for alcohol on days of dosing
14. Unwillingness or inability to abstain from alcohol use at least 24 hours prior to the days of dosing, up to 24 hours after each dosing day (or corresponding intervals for waitlist group).
15. Any medical conditions that may render study procedures unsafe, including hypertension, history of cardiovascular disease, moderate-to-severe hepatic or renal impairment, diabetes, and hypo- or hyperthyroidism.

Contacts and Locations

Study Contact

Terence Ching, PhD

CONTACT

(203) 974-7731

terence.ching@yale.edu

Principal Investigator

Benjamin Kelmendi, MD

PRINCIPAL_INVESTIGATOR

Yale University

Terence Ching, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Christopher Pittenger, MD, PhD

STUDY_DIRECTOR

Yale University

Study Locations (Sites)

Connecticut Mental Health Center

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Yale University

Benjamin Kelmendi, MD, PRINCIPAL_INVESTIGATOR, Yale University
Terence Ching, PhD, PRINCIPAL_INVESTIGATOR, Yale University
Christopher Pittenger, MD, PhD, STUDY_DIRECTOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-20

Study Completion Date2027-07

Study Record Updates

Study Start Date2023-07-20

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

Psilocybin

Additional Relevant MeSH Terms

Obsessive-Compulsive Disorder