Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study.

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate psilocybin's purported therapeutic effects on OCD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Heffter Research Institute
• Treatments: Niacin; Niacinamide; Nicotinic Acids; Psilocybin

Criteria

Inclusion Criteria:

1. DSM-5 diagnosis of OCD established by a trained clinician interview and confirmed by Mini International Neuropsychiatric Interview MINI (edition 7).

2. YBOCS score of 18 or greater at evaluation

3. Patients must have failed at least one medication and/or therapy trial of standard care treatment for OCD.

4. English speaking - able to understand the process of consent and the risk and benefits associated with the study, and able to give written informed consent

5. Must be willing to sign a medical release for the investigators to communicate directly with their therapist and doctors to confirm a medication and/or medical history. This is decided on a case by case basis upon the discretion of the PI.

6. Must be medically cleared by the PI or another medical doctor before they can drive home the morning after the experimental sessions, after the 48-hour post-session assessments. They can also be driven home by a driver arranged by the subject or by the site personnel or taxi.

7. Has been off selective serotonin inhibitors for five half-lives of the drug plus 2 weeks.

8. Must avoid starting a new psychiatric medication during the study. Should participant's doctor recommend starting a new psychiatric medication, participant will be required to notify the study team.

9. 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 a participant becoming suicidal.

10. Are willing to refrain from taking any psychiatric medications during the study period.

11. Must have a negative pregnancy test at study entry and prior to each experimental session if able to bear children, and must agree to use adequate birth control

12. Are willing to commit to medication dosing, experimental sessions, follow-up sessions, to complete evaluation

Exclusion Criteria:

1. Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder.

2. Active suicidal intent

3. Unremitted Tourette syndrome

4. Pervasive developmental disability

5. Current substance abuse disorder (except in the case of mild alcohol use disorder).

6. Anxiolytic, neuroleptic and SRI medications

7. Unstable neurological or medical condition; history of seizure, chronic/severe headaches.

8. Any contraindications to undergoing an MRI scan, including having metal implants or metal fragments in the body. With participants who may have been exposed to metal fragments and who wish to participate in the MRS scans, a plain film X-ray may be order to clarify their eligibility status. Women of childbearing potential who elected not to have the pregnancy test, will be excluded from MRI.

9. Any history of head injury with loss of consciousness for more than 30 minutes

10. Positive urine pregnancy test at the time of screening

11. Any use of psychedelic drugs within the prior 12 months.

12. Any unstable medical condition that my render study procedures unsafe.