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Hallucinogen

Psilocybin 300 mcg/kg for Obsessive-Compulsive Disorder (PSILOCD Trial)

Phase 1
Waitlist Available
Led By Francisco A. Moreno, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0, and 24 hours after blinded medication ingestion
Awards & highlights

Summary

This trial will study whether psilocybin can help treat OCD and if it is safe to use. It will also look at how the drug works.

Eligible Conditions
  • Obsessive-Compulsive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0, and 24 hours after blinded medication ingestion
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0, and 24 hours after blinded medication ingestion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment-phase effects on Obsessive-Compulsive symptom severity
Secondary outcome measures
Acute Incidence of Treatment Emergent Adverse Events
Changes in functional connectivity: 1) between the Caudate Nucleus (CN) and Orbital Frontal Cortex (OFC); 2) within the default mode network (DMN).
Changes in the magnitude of Error Related Negativity (an electroencephalographic biomarker of OCD) assessed by Error-related negativity (voltage) and mid-frontal theta power (time-frequency approach)
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: High-dose PsilocybinExperimental Treatment1 Intervention
Psilocybin 300 mcg/kg once per week, every week, for 8 weeks
Group II: High- or Low-dose PsilocybinExperimental Treatment2 Interventions
Psilocybin 100 mcg/kg or psilocybin 300 mcg/kg once per week, every week, for 8 weeks
Group III: High-dose Psilocybin or LorazepamPlacebo Group2 Interventions
Psilocybin 300 mcg/kg or Lorazepam 1 mg once per week, every week, for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin 300 mcg/kg
2019
Completed Phase 1
~20
Psilocybin 100 mcg/kg
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
518 Previous Clinical Trials
148,694 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
192 Patients Enrolled for Obsessive-Compulsive Disorder
Francisco A. Moreno, MDPrincipal InvestigatorProfessor of Psychiatry and Associate Vice President, Diversity and Inclusion
~2 spots leftby Jul 2025