COMP360 psilocybin for PTSD: see if it helps reduce symptoms with guided support
Official title: A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Run by COMPASS Pathways · NCT07570654 · Data updated 2026-11-12
This study tests COMP360 (a lab-made psilocybin) to see if it can help reduce PTSD symptoms in adults, with supervision from a trained team.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | COMPASS Pathways Industry-sponsored |
| Locations | 17 sites (Tucson, Arizona and 16 other locations) |
| Status | Recruiting |
| Started | September 14, 2026 |
| Main results expected | November 2028 |
| Study ends | September 2029 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07570654 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older with a PTSD diagnosis for at least six months are eligible, provided they do not have excluded psychiatric conditions.
✕Probably not a fit
Individuals with certain psychiatric disorders (e.g., bipolar disorder, schizophrenia, OCD) or other excluded conditions may not benefit and could be at risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study explores whether COMP360, a laboratory-made psilocybin, can lessen PTSD symptoms when given alongside structured monitoring and care. It includes adults with a PTSD diagnosis for at least six months and excludes certain psychiatric conditions. The trial combines two phases (Phase 2 and Phase 3) to evaluate safety, tolerability, and efficacy. Participants receive the medication under controlled conditions with clinical support to manage effects. Primary sites are in Tucson, AZ and two California locations (Irvine and Los Angeles).
Why it matters
Potential benefit: If successful, participants may experience a reduction in PTSD symptoms and improved well-being with supervised treatment.
How similar studies have gone: Prior research in psychedelic-assisted therapy for PTSD is emerging but remains a developing area with mixed results; this study contributes additional evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Diagnosed with PTSD at least 6 months ago Exclusion Criteria: \- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions
Where it's running
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Az
Tucson, Arizona, United States Recruiting -
Ca
Irvine, California, United States Recruiting -
Ca
Los Angeles, California, United States Recruiting -
Ca
Moorpark, California, United States Recruiting -
Fl
Miami, Florida, United States Recruiting -
Fl
Orlando, Florida, United States Recruiting
Show 11 more locations
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Il
Chicago, Illinois, United States Recruiting -
Ma
Boston, Massachusetts, United States Recruiting -
Mn
Eden Prairie, Minnesota, United States Recruiting -
Ne
Lincoln, Nebraska, United States Recruiting -
Nv
Las Vegas, Nevada, United States Recruiting -
Ny
New York, New York, United States Recruiting -
Ny
The Bronx, New York, United States Recruiting -
Oh
North Canton, Ohio, United States Recruiting -
Tx
Carrollton, Texas, United States Recruiting -
Bc
Kamloops, British Columbia, Canada Recruiting -
Bc
North Vancouver, British Columbia, Canada Recruiting
Study contacts
- Study coordinator: www.redefineptsdstudy.com Redefine Study Call Center
- Email: TheRedefineStudy@compasspathways.com
- Phone: 202-459-9258
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Non-invasive vagus nerve stimulation (gammaCore) for PTSD
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-
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-
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ReVIVE for mTBI: Using VR and therapy to help adults with mild traumatic brain injury
This study tests a virtual reality therapy combined with standard psychotherapy to see if it can reduce PTSD symptoms and improve executive function in adults with mild traumatic brain injury.
-
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.