Clinical trial Recruiting at 17 sites Phase2; Phase3 Interventional Ages 18 and up

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

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorCOMPASS Pathways
Industry-sponsored
Locations17 sites (Tucson, Arizona and 16 other locations)
StatusRecruiting
StartedSeptember 14, 2026
Main results expectedNovember 2028
Study endsSeptember 2029
Registry record updatedNovember 5, 2026
Trial IDNCT07570654 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.