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Psychedelic Therapy

Psilocybin for PTSD (PSI-3PO Trial)

Phase 1
Recruiting
Led By Sandeep Nayak, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
21 to 75 years old
Have a confirmed DSM-5 diagnosis of Post-Traumatic Stress Disorder with symptom duration >= 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights

Summary

This trial will test if psilocybin therapy is safe and effective for adult patients with chronic PTSD who are already taking medication. It will also look at whether combining psilocybin therapy with trauma

Who is the study for?
Adults aged 21-75 with chronic PTSD, diagnosed per DSM-5, and on a stable dose of serotonin reuptake inhibitors for at least two weeks. Participants must have a CAPS-5 score of >=35, be low risk for suicide, agree to consistent caffeine intake on session days, avoid psychoactive substances before sessions, and pass medical screenings.
What is being tested?
The study is testing if psilocybin therapy can safely reduce PTSD symptoms and improve wellbeing when combined with trauma-focused psychotherapy. It's an open-label trial where all participants know they're receiving the treatment being studied.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of psilocybin may include nausea, headache, dizziness, increased heart rate or blood pressure changes. Psychological effects could range from anxiety to profound changes in perception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 75 years old.
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I have been diagnosed with PTSD for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5)
Columbia Suicide Severity Rating Scale (C-SSRS)
Ecological Momentary Assessment (EMA) of PTSD Checklist for DSM-5 (PCL-5)
+2 more
Secondary outcome measures
Beck Depression Inventory II (BDI-II)
Posttraumatic Maladaptive Beliefs Scale (PMBS)
Sheehan Disability Scale (SDS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Trauma-focused psychotherapy treatment conditionExperimental Treatment3 Interventions
Individuals in this arm will undergo procedures related to trauma-focused psychotherapy (combined with standard psychological support) beginning after receipt of psilocybin.
Group II: Standard psychological support treatment conditionActive Control2 Interventions
This condition represents typical support following the experimental administration of psilocybin therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,889 Total Patients Enrolled
Sandeep Nayak, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
180 Total Patients Enrolled
~13 spots leftby May 2026
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