Clinical TrialObsessive-Compulsive Disorder (OCD)PsilocybinPlaceboCompleted

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

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.

Target Enrollment
31 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, double-blind, active-placebo-controlled, single-dose study (psilocybin 0.25 mg/kg vs niacin 250 mg) in participants with moderate–severe OCD; participants are admitted inpatient for the dosing week.

Primary clinical assessments at 24 and 48 hours and at 1 week, 2 weeks, 1 month and 3 months; resting-state fMRI at baseline and 48 hours to examine fronto-striatal connectivity changes and their relation to symptom improvement.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Psilocybin 0.25 mg/kg oral

Interventions

  • Psilocybin0.25 mg/kg
    via Oral• single dose• 1 doses total

    Inpatient dosing with baseline and 48-hour fMRI follow-up

Niacin

active

Niacin 250 mg (active placebo)

Interventions

  • Placebo250 mg
    via Oral• single dose• 1 doses total

    Active-placebo comparator; participants offered open-label psilocybin after 48 hours

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Primary DSM-5 diagnosis of OCD
  • 2. Y-BOCS score of 19 or greater
  • 3. Failure of at least one trial of standard care treatment (medication and/or psychotherapy [CBT/ERP]) for OCD
  • 4. English proficiency and fluency, and ability to understand the consent process and provide written informed consent
  • 5. Willingness to sign a medical release for direct communication between research staff and external provider(s) about the participant's treatment and medical histories
  • 6. Non-consumption of SSRIs for at least 8 weeks at the time of randomization
  • 7. 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
  • 8. Willingness to abstain from THC-containing products for study duration. A negative urinary drug screen is also required at baseline and the day of dosing.
  • 9. A negative urinary pregnancy screen at study entry and day of dosing if of childbearing potential, and willingness to use adequate birth control for study duration
  • 10. Having a contact person who is willing and able to be reached by the study team in the event of an emergency/crisis, and who is able to transport the participant home at the end of the inpatient stay/dosing week
  • 11. Willingness to commit to all study procedures and visits, including inpatient stay, assessments and self-reports, neuroimaging, and being medically cleared to be discharged and transported home at the end of the dosing week

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Personal or immediate family history of schizophrenia spectrum and other psychotic disorders, bipolar I or II disorder, or major depressive disorder with psychotic features
  • 2. Active suicidal intent
  • 3. Unremitted Tourette syndrome
  • 4. Autism spectrum disorder
  • 5. OCPD or BPD
  • 6. Current substance use disorder (except mild alcohol use disorder)
  • 7. Unstable neurological or medical condition(s) that may render study procedures unsafe, including poorly managed diabetes, hypertension, or cardiovascular conditions, or history of seizure(s) or chronic/severe headaches
  • 8. Any history of head injury with loss of consciousness for more than 30 minutes
  • 9. Any contraindications to undergoing an MRI scan, including having metal implants or metal fragments in the body
  • 10. Any use of psychedelic substances within the prior 12 months

Study Details

Locations

Connecticut Mental Health Center — New Haven, Connecticut, United States

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