Compass's psilocybin PTSD trial is recruiting at a Miami site

What the Redefine study tests

The registry record, NCT07570654, describes a Phase 2b/3 trial that is randomized, double-blind and controlled, with an open-label extension, testing COMP360 in adults with PTSD.¹ It calls COMP360 "a lab-made form of the naturally occurring chemical compound psilocybin," given "alongside monitoring and support from a trained study team."¹

Participants are randomly assigned to COMP360 at 25 mg or 10 mg, or to a 1 mg comparator. The main measure compares the 25 mg and 1 mg groups on the change in CAPS-5, a clinician-run PTSD interview, from baseline to week 8. Participants, care providers, investigators and outcome assessors aren't told who got which strength.¹

The record estimates a September 2026 start, primary completion around November 2028 and study completion around September 2029. It was first posted May 6, 2026 and last updated Oct. 23.¹

Who runs it, and where are the sites?

The sponsor is Compass Pathways, the London-based company that is also seeking FDA approval of COMP360 for treatment-resistant depression. Its Aug. 5 results release listed a "late-stage PTSD trial underway."²

All 10 sites are marked recruiting: Tucson; Miami; Orlando; Chicago; Eden Prairie, Minn.; Lincoln, Neb.; Las Vegas; New York; the Bronx; and North Vancouver, British Columbia.¹ The record doesn't name the clinics. It lists each site only by a state or province code, so the registry doesn't say who operates the Miami location.

One discrepancy: USF Health's psychiatry department lists a "Compass COMP 202 PTSD" psilocybin study among its trials open to enrollment, but the registry record for COMP202 shows no Tampa site.³¹ We report what each source says.

Who can join the PTSD trial?

The record's public criteria are short: adults 18 or older who were "diagnosed with PTSD at least 6 months ago." It excludes people "diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions," and it doesn't accept healthy volunteers.¹ Screening decides who enrolls. Because assignment is random and blinded, joining doesn't guarantee one of the higher strengths.

How do you contact the study?

Use the registry record. Its "Contacts and Locations" section lists a central contact for Redefine, a study call center with a phone number and an email address, instead of numbers for individual sites.¹ ClinicalTrials.gov describes a study contact as "someone who can answer questions about joining the study, the types of participants the study is looking for, and what happens during the study."⁸

Anyone who enrolls signs an informed consent document first, which ClinicalTrials.gov says covers what will happen, how much time the study takes and "any payments and costs." Participants "can leave the study at any time and for any reason."⁴

Why it matters in Miami

For a South Florida adult with PTSD, a screened place in a registered trial is one of the few legal ways to receive psilocybin in Florida. Outside research, psilocybin is a Schedule I drug in Florida, s. 893.03(1)(c)33., and possessing any amount is a third-degree felony under s. 893.13(6)(a).⁵⁶

On Nov. 2, Redefine was the only trial matching "psilocybin" on ClinicalTrials.gov with a recruiting site in Miami-Dade, Broward or Palm Beach; the other recruiting Florida match, a trial of a psilocin analog, lists sites in Jacksonville, Maitland, Naples and Tampa.⁷ A separate recruiting trial of RE104, a different compound, lists a site in Lauderhill.⁹ Veterans should note that the VA's own psilocybin trial has no Florida site. Our Florida trials tracker lists every study with a Florida location.