Psilocybin for PTSD

Recruiting in Palo Alto (17 mi)

Overseen byGosia Phillips, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Halucenex Life Sciences Inc.

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing psilocybin, a substance from 'magic mushrooms,' on people with PTSD who don't respond to current treatments. Psilocybin helps the brain grow and reduces fear response, which may improve mood and reduce anxiety. Psilocybin has shown promise in treating anxiety and depression in patients with life-threatening cancer, with significant and sustained symptom reduction.

Eligibility Criteria

This trial is for adults aged 18-70 with treatment-resistant PTSD, having moderate to severe symptoms despite at least 3 months of SSRI or SNRI treatment and 4 months of psychotherapy. Participants must understand English. Excluded are those with certain psychiatric disorders, uncontrolled medical conditions, recent substance abuse, high caffeine intake, or who are pregnant without using contraception.

Inclusion Criteria

Subjects must meet the following criteria to be eligible for enrollment into the study.

Subjects must have treatment-resistant PTSD symptoms, defined as a CAPS score of ≥50 (signifying moderate to severe symptoms) following at least 3 months of prior SSRI or SNRI treatment in addition to at least 4 months of psychotherapy.

Subjects must be ≥18 and ≤70 years of age.

+4 more

Exclusion Criteria

You have a substance use disorder that could affect the goals of the study, such as drinking more than 5 cups of coffee with caffeine each day, being unable to go without smoking cigarettes or cannabis without feeling uncomfortable, or drinking alcohol within 7 hours before the study.

You are afraid or uncomfortable with having blood drawn or getting injections with needles.

You have been diagnosed with a personality disorder that significantly affects your mental health.

+10 more

Participant Groups

The study tests the effects of psilocybin on individuals with PTSD that hasn't improved after standard treatments. It aims to see if psilocybin can alleviate PTSD symptoms when traditional medications like paroxetine and sertraline have failed.

1Treatment groups

Experimental Treatment

Group I: Psilocybin treatment for treatment-resistant PTSDExperimental Treatment1 Intervention

Experimental Treatment: Experimental: Psilocybin 10mg (low dose) on Day 7 25mg (high dose) on Day 14 10mg dose (optional top-up low dose) at Month 7 Treatment Description: Drug: Psilocybin drug product suspension Psilocybin is manufactured as a bulk API powder. The psilocybin drug product suspension is prepared by a compounding pharmacist at the clinic site. The psilocybin drug product suspension will be mixed in a glass with water to produce the psilocybin solution for oral consumption. Subjects will be instructed to orally consume the study medication in the glass in its entirety. Psilocybin will be administered in the following doses and at the following time points for this study: * 1 mL of 10mg/mL (low dose) on Day 7 (10 mg) * 2.5 mL of 10 mg/mL (high dose) on Day 14 (25 mg) * \[Optional dose\] 1 mL of 10mg/mL (low dose) on Month 7/Day 210 (10 mg)

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Psilocybin for: