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Hallucinogen
Psilocybin for Treatment of 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
Summary
This trial will test if psilocybin can improve symptoms in people with OCD who haven't responded to other treatments. Psilocybin is a drug that changes brain activity and may help reduce OCD symptoms. Participants will receive different doses of psilocybin or a calming medication and be monitored for safety and effectiveness. Psilocybin has been studied for its potential to treat various psychiatric disorders, including anxiety, depression, and substance use disorders, with some trials showing significant improvements in symptoms.
Eligible Conditions
- OCD
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 0, and 24 hours after blinded medication ingestion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0, and 24 hours after blinded medication ingestion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment-phase effects on Obsessive-Compulsive symptom severity
Secondary study objectives
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 moreTrial 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
536 Previous Clinical Trials
159,682 Total Patients Enrolled
Francisco A. Moreno, MDPrincipal InvestigatorProfessor of Psychiatry and Associate Vice President, Diversity and Inclusion