Psilocybin clinical trials in Florida: every drug trial with a Florida site

The short answer

As of November 2, 2026, ClinicalTrials.gov lists 14 drug trials with at least one Florida site that test psilocybin or one of two related compounds: 8 test psilocybin, 3 test CYB003 (a psilocin analog) and 3 test RE104 (a different compound). Four of the 14 are recruiting.¹

Only two are recruiting at a site in Miami-Dade, Broward or Palm Beach: Compass Pathways' psilocybin study for PTSD, which has a Miami site, and Reunion Neuroscience's RE104 study for generalized anxiety, which has a Lauderhill site.²³ Psilocybin is a Schedule I drug in Florida (see our Florida law guide), so a registered study is the realistic legal route to receiving it here. Joining one means screening, strict exclusions and no promise that you'll get the drug.

What does the Florida trial list show?

We searched ClinicalTrials.gov, the federal registry, for interventional studies of psilocybin, CYB003 and RE104 and kept every record with a Florida site.¹ The 14, by registry status:

Nine of the 14, including five of the eight psilocybin trials, list a site in Miami-Dade, Broward or Palm Beach. The oldest Miami listing never got going: a study of psilocybin for anxiety in people with stage IV melanoma, registered in 2009 with a start listed as January 2012 at Mount Sinai Comprehensive Cancer Center in Miami Beach, was withdrawn with no one enrolled.¹

Two compounds on the list are not psilocybin

The registry records for Cybin's three CYB003 trials call the drug "a Deuterated Psilocin Analog." RE104 (luvesilocin) is an injection, and its records don't call it a psilocybin analog; its maker, Reunion Neuroscience, describes it as "a proprietary, short-duration, patented prodrug of 4-OH-DiPT, a 5HT2a agonist."¹⁴ We include both, labeled, because they are the closest relatives of psilocybin being tested in Florida and two of the four recruiting trials are RE104 studies. We left out one observational Usona follow-up study (NCT04353921) in Lauderhill, because no drug was given in it.¹

Sponsors update their own records, so a status can lag (one Compass record hasn't changed since August 2025). The filters show Miami-area trials or one registry status at a time.

Which trials are recruiting in Miami right now?

Compass Pathways' Redefine study for PTSD

Redefine (NCT07570654) is a Phase 2b/3 study of COMP360, which the record calls "a lab-made form of the naturally occurring chemical compound psilocybin." It aims to enroll an estimated 300 adults at 10 sites, including one in Miami and one in Orlando, though the record names neither clinic. You must be 18 or older and have been "Diagnosed with PTSD at least 6 months ago"; people diagnosed with "certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions" are excluded.²

Everyone in Redefine receives COMP360, but not the same amount: participants are randomly assigned to 1 mg, 10 mg or 25 mg, and the 1 mg group is the comparison. Participants, care providers, investigators and outcome assessors are all blinded.²

Reunion Neuroscience's RE104 study for generalized anxiety

The other South Florida trial tests RE104, not psilocybin. The Phase 2 study (NCT07489651) plans to enroll an estimated 160 adults aged 18 to 74 with generalized anxiety disorder, at Innovative Clinical Research in Lauderhill and the University of South Florida in Tampa. Participants receive RE104 or a saline placebo injection. It excludes people with "a significant risk of suicide," a history of bipolar disorder, schizophrenia, psychotic disorder or borderline personality disorder, or a "first-degree family history of psychosis or bipolar disorder."³

Recruiting elsewhere in Florida

Cybin's EMBRACE study of CYB003 for depression is recruiting in Jacksonville, Maitland, Naples and Tampa.¹ Reunion's RE104 study for adjustment disorder in people with cancer and other illnesses (NCT07002034) is recruiting at USF in Tampa. Cybin's EXTEND study, with South Florida sites in Hollywood and Lauderhill and others in four Florida cities farther north, is "enrolling by invitation": only people who completed APPROACH or EMBRACE can join.¹

How does joining a psilocybin trial work?

Every trial starts with screening against eligibility criteria, which ClinicalTrials.gov says researchers use "to keep participants safe and enroll the right participants."⁵ Across the Florida records, the common exclusions are a history of psychotic or bipolar disorders (often in close relatives too) and a significant risk of suicide.¹³

Medication rules differ. EMBRACE requires a stable antidepressant and keeps participants on it, while the RE104 anxiety study excludes anyone who "has used or will need to use prohibited medications or therapies."¹³ Don't stop or change a prescription on your own to qualify; that's a decision for the study team and your prescriber.

You may not get the drug

ClinicalTrials.gov says participants "may not get the intervention being tested" and "may get the standard treatment or no treatment at all."⁵ On the Florida list, comparison groups get an inactive placebo (for example, in Usona's Phase 3 and Cybin's APPROACH), a saline injection (the RE104 anxiety study), niacin (Usona's Phase 2) or a very low amount of the same drug (for example, Compass's COMP006 and Redefine).¹³

Assignment is usually random, and "participants may not know what group (or intervention) they have been assigned, and the staff may not know either." Participants "may or may not get any benefit themselves," consent should cover "any payments and costs," and anyone can "leave the study at any time and for any reason."⁵

How do I contact a study?

Use the registry record and nothing else. Open the trial's page on ClinicalTrials.gov (each entry in our list links to it) and use its contacts and locations section, which lists the study's contacts when the sponsor provides them. Redefine, for example, lists a study call center but no Florida clinic names.²

Check the NCT number, status and "last updated" date. A listing is not a stamp of approval: "The U.S. government does not review or approve the safety and science of all studies listed on this website," the registry's disclaimer says, and its advice is to "discuss all options with your health care professional" before joining.¹⁶ An offer of psilocybin "sessions" that can't be tied to a registry record is not a trial; our psychedelic therapy guide explains how to spot one.

Which Florida universities do psychedelic research?

Most South Florida sites on the list are private research clinics, not universities: a Lauderhill company listed as Segal Trials or Innovative Clinical Research (the record of Usona's follow-up study calls the latter "formerly Segal Trials") appears in at least five of the 14 trials.¹³

University of Miami

No University of Miami site appears in any of the 14 records.¹ The UM psychedelic research we found is observational, not drug trials: UM epidemiologist Denise Vidot's Global Cannabis and Psychedelics Research Collaboratory (GCAP) studies the health effects of psychedelics and cannabis. "A lot of people are jumping into psychedelic research, but this is not new for us," Vidot told UM's news office in August 2026.⁶ A 2026 paper from her group used the National Survey on Drug Use and Health to estimate lifetime psychedelic and cannabis use among U.S. cancer survivors aged 50 and older.⁷

University of South Florida

USF Health's psychiatry department says it "is conducting a series of clinical trials investigating the use of psychedelic medications to treat mental health."⁸ In the registry, USF in Tampa is a site on Compass's COMP006 depression trial and on both recruiting RE104 trials.¹³

University of Florida

UF in Gainesville was the only site of a Tryp Therapeutics pilot of psilocybin for binge eating disorder. The registry lists five participants and an open-label design, meaning everyone knew they got psilocybin and there was no placebo group.¹

FIU, FAU and Nova Southeastern

We found no named psychedelic research program at Florida International, Florida Atlantic or Nova Southeastern, and none is a site on the list.¹

Has Florida funded psilocybin research?

No. Florida's enacted budgets for 2024-25, 2025-26 and 2026-27 contain no line for psilocybin or psychedelic research; none uses the word psilocybin.⁹¹¹¹²

It came close once. The Senate's version of the 2024 budget included $650,000 for a "University of South Florida Medical Center - Psilocybin study in Veterans with PTSD," but the final budget dropped it.¹⁰⁹ On February 18, 2025, then-Sen. Jay Collins filed a $3,000,000 request that said: "This funding will allow USF Health to conduct a clinical trial into the efficacy of Psilocybin as a treatment for PTSD in veterans."¹³ It is not in the 2025-26 budget.¹¹

Don't mistake two kinds of items for psychedelic funding. The 2025-26 budget included $735,000 for "Controlled Ketamine Therapy for Veterans," a different drug.¹¹ And each budget funds USF items titled "Veteran PTSD Study" and "Veteran PTSD & Traumatic Brain Injury Study," which the budget text doesn't describe as psychedelic research.⁹¹²

Are there LSD, MDMA or ibogaine trials in Florida?

LSD, yes. Five trials of MM120 (also called DT120), whose records list "lysergide tartrate" among its names, have Florida sites. One, a Phase 3 depression study called Ascend, is recruiting in Jacksonville, Maitland, Orlando and Tampa. Two of the five, both for anxiety, list a Lauderhill site.¹⁴

MDMA and ibogaine, no. A registry search for MDMA, midomafetamine, ibogaine and noribogaine at Florida locations returned no studies of any status on November 2, 2026.¹⁵ For what is legal outside Florida, see our guide to legal psilocybin options near Miami.