{ "name": "Psilocybin and related clinical trials with a Florida site", "description": "Interventional studies of psilocybin, and of two related compounds labeled as such, registered on ClinicalTrials.gov with at least one Florida site: sponsor, phase, status, Florida sites and dates.", "publisher": "Magic Mushrooms Miami", "url": "https://magicmushroomsmiami.com/psilocybin-clinical-trials-florida", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "updated": "2026-11-02", "record_count": 14, "source_note": "Records come from the ClinicalTrials.gov API. Recruitment status is the registry's, as listed on the date checked; contact the study team before relying on it.", "records": [ { "nct": "NCT07570654", "title": "Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder", "sponsor": "COMPASS Pathways", "phase": "Phase 2/3", "status": "Recruiting", "status_key": "recruiting", "condition": "Post-traumatic stress disorder (PTSD)", "enrollment": "300 (estimated)", "dates": "Start September 2026 (estimated); primary completion November 2028 (estimated)", "fl_sites": "Site name not listed, Miami; site name not listed, Orlando", "miami_area": true, "updated": "October 23, 2026", "url": "https://clinicaltrials.gov/study/NCT07570654", "note": "The registry gives only the city for its Florida sites, not the clinic names, so use the contact listed on the record." }, { "nct": "NCT07489651", "title": "RE104 Safety and Efficacy Study in Generalized Anxiety Disorder", "sponsor": "Reunion Neuroscience Inc", "phase": "Phase 2", "status": "Recruiting", "status_key": "recruiting", "condition": "Generalized anxiety disorder", "enrollment": "160 (estimated)", "dates": "Started April 2026; primary completion July 2027 (estimated)", "fl_sites": "Innovative Clinical Research, Inc., Lauderhill; University of South Florida, Tampa", "miami_area": true, "updated": "September 24, 2026", "url": "https://clinicaltrials.gov/study/NCT07489651", "note": "RE104 is not psilocybin: its maker describes it as a prodrug of 4-OH-DiPT, and this study compares it with a placebo injection." }, { "nct": "NCT06793397", "title": "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder", "sponsor": "Cybin IRL Limited", "phase": "Phase 3", "status": "Recruiting", "status_key": "recruiting", "condition": "Major depressive disorder", "enrollment": "330 (estimated)", "dates": "Started December 2025; primary completion June 2027 (estimated)", "fl_sites": "CNS Healthcare, Jacksonville; Accel Research Sites - Maitland, Maitland; Aqualane Clinical Research, Naples; K2 Medical Research Tampa, Tampa", "miami_area": false, "updated": "November 2, 2026", "url": "https://clinicaltrials.gov/study/NCT06793397", "note": "This is the EMBRACE study; CYB003 is a deuterated psilocin analog, not psilocybin, and no South Florida site is listed." }, { "nct": "NCT07002034", "title": "RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses", "sponsor": "Reunion Neuroscience Inc", "phase": "Phase 2", "status": "Recruiting", "status_key": "recruiting", "condition": "Adjustment disorder in people with cancer or other medical illnesses", "enrollment": "100 (estimated)", "dates": "Started July 2025; primary completion November 2026 (estimated)", "fl_sites": "University of South Florida, Department of Psychiatry and Behavioral Neuroscience, Tampa", "miami_area": false, "updated": "September 15, 2026", "url": "https://clinicaltrials.gov/study/NCT07002034", "note": "RE104 is not psilocybin: its maker describes it as a prodrug of 4-OH-DiPT, a different compound." }, { "nct": "NCT06605105", "title": "Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)", "sponsor": "Cybin IRL Limited", "phase": "Phase 3", "status": "Enrolling by invitation", "status_key": "invitation", "condition": "Major depressive disorder (long-term extension)", "enrollment": "468 (estimated)", "dates": "Started July 2025; primary completion June 2028 (estimated)", "fl_sites": "Research Centers of America, Hollywood; Clinical Neuroscience Solutions, Jacksonville; K2 Medical Research, Lady Lake; Segal Trials Center for Psychedelic Research, Lauderhill; Accel Research Sites - Maitland, Maitland; K2 Medical Research, Maitland; Clinical Neuroscience Solutions, Inc, Orlando; Charter Research, Orlando; Combined Research Orlando Phase I-IV, Orlando", "miami_area": true, "updated": "September 25, 2026", "url": "https://clinicaltrials.gov/study/NCT06605105", "note": "CYB003 is a deuterated psilocin analog, not psilocybin, and this extension is open only to people who completed the APPROACH or EMBRACE trials." }, { "nct": "NCT05711940", "title": "Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD", "sponsor": "COMPASS Pathways", "phase": "Phase 3", "status": "Active, not recruiting", "status_key": "active", "condition": "Treatment-resistant depression", "enrollment": "572 (actual)", "dates": "Started February 2023; primary completion November 2025", "fl_sites": "Innovative Clinical Research, Inc., Lauderhill; Central Miami Medical Institute, LLC, Miami; Behavioral Clinical Research, Inc., Miami Lakes; Health Synergy Clinical Research, Okeechobee; Clinical Neurosciecne [sic] Solutions, Inc. dba CNS Healthcare, Orlando; APG Research, LLC- Advanced Psychiatric Group, Orlando; University South Florida, Tampa; Stedman Clinical Trials, Tampa; Health Synergy Clinical Research, LLC, West Palm Beach", "miami_area": true, "updated": "August 10, 2026", "url": "https://clinicaltrials.gov/study/NCT05711940", "note": "Tested two administrations of COMP360 against a low-dose comparator rather than an inactive placebo." }, { "nct": "NCT06308653", "title": "Psilocybin for Major Depressive Disorder (MDD)", "sponsor": "Usona Institute", "phase": "Phase 3", "status": "Active, not recruiting", "status_key": "active", "condition": "Major depressive disorder", "enrollment": "238 (actual)", "dates": "Started March 2024; primary completion January 2026", "fl_sites": "Clinical Neuroscience Solutions Inc., Jacksonville; Innovative Clinical Research, Inc., Lauderhill; Clinical Neuroscience Solutions, Inc., Orlando", "miami_area": true, "updated": "October 21, 2026", "url": "https://clinicaltrials.gov/study/NCT06308653", "note": "Compares two psilocybin dose levels with an inactive placebo; its primary completion date has passed, but no results are posted yet." }, { "nct": "NCT05733546", "title": "A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder", "sponsor": "COMPASS Pathways", "phase": "Phase 2", "status": "Active, not recruiting", "status_key": "active", "condition": "Recurrent major depressive disorder", "enrollment": "102 (actual)", "dates": "Started January 2023; primary completion September 2025 (estimated)", "fl_sites": "Clinical Neuroscience Solutions Inc, Jacksonville", "miami_area": false, "updated": "August 19, 2025", "url": "https://clinicaltrials.gov/study/NCT05733546", "note": "The record was last updated in August 2025 with an estimated primary completion of September 2025, so the status shown may be out of date." }, { "nct": "NCT03866174", "title": "A Study of Psilocybin for Major Depressive Disorder (MDD)", "sponsor": "Usona Institute", "phase": "Phase 2", "status": "Completed", "status_key": "completed", "condition": "Major depressive disorder", "enrollment": "347 (actual)", "dates": "Started January 2020; primary completion June 2022; study completed June 2022", "fl_sites": "Segal Trials, Lauderhill", "miami_area": true, "updated": "April 22, 2026", "url": "https://clinicaltrials.gov/study/NCT03866174", "note": "The registry counts 347 people who gave consent, of whom 104 were randomized across 11 US sites." }, { "nct": "NCT05624268", "title": "Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD", "sponsor": "COMPASS Pathways", "phase": "Phase 3", "status": "Completed", "status_key": "completed", "condition": "Treatment-resistant depression", "enrollment": "258 (actual)", "dates": "Started January 2023; primary completion May 2025; study completed April 2026", "fl_sites": "Clinical Neurosciecne [sic] Solutions, Inc. dba CNS Healthcare, Orlando; APG Research, LLC, Orlando; DMI Health Care Group, Inc, Tampa; Meridien Research/Accel Research, Tampa", "miami_area": false, "updated": "August 10, 2026", "url": "https://clinicaltrials.gov/study/NCT05624268", "note": "A Phase 3 trial (COMP005) comparing COMP360, Compass Pathways' lab-made psilocybin, with a matched placebo." }, { "nct": "NCT05035927", "title": "Evaluation of Psilocybin (TRP-8802) in the Treatment of Binge Eating Disorder", "sponsor": "TRYP Therapeutics", "phase": "Phase 2", "status": "Completed", "status_key": "completed", "condition": "Binge eating disorder", "enrollment": "5 (actual)", "dates": "Started March 2022; primary completion March 2024; study completed June 2024", "fl_sites": "University of Florida, Gainesville", "miami_area": false, "updated": "November 19, 2024", "url": "https://clinicaltrials.gov/study/NCT05035927", "note": "A small open-label pilot, with no placebo group, run at the University of Florida." }, { "nct": "NCT06564818", "title": "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder", "sponsor": "Cybin IRL Limited", "phase": "Phase 3", "status": "Completed", "status_key": "completed", "condition": "Major depressive disorder", "enrollment": "223 (actual)", "dates": "Started December 2024; primary completion September 2026; study completed October 2026", "fl_sites": "Research Centers of America, Hollywood; K2 Medical Research-Maitland, Maitland; Floridian Neuroscience Institute, Miami; Segal Trials West Broward, North Miami; Clinical Neuroscience Solutions, Inc, Orlando; Charter Research, Orlando; Combined Research Orlando Phase I-IV, Orlando; K2 Medical Research - Tampa, Tampa", "miami_area": true, "updated": "October 27, 2026", "url": "https://clinicaltrials.gov/study/NCT06564818", "note": "This is the APPROACH study, and CYB003 is a deuterated psilocin analog, not psilocybin." }, { "nct": "NCT06342310", "title": "RE104 Safety and Efficacy Study in Postpartum Depression", "sponsor": "Reunion Neuroscience Inc", "phase": "Phase 2", "status": "Completed", "status_key": "completed", "condition": "Postpartum depression", "enrollment": "84 (actual)", "dates": "Started June 2024; primary completion May 2025; study completed June 2025", "fl_sites": "Reunion Investigational Site, Lauderhill; Reunion Investigational Site, Tampa", "miami_area": true, "updated": "May 14, 2026", "url": "https://clinicaltrials.gov/study/NCT06342310", "note": "RE104 (luvesilocin) is not psilocybin: its maker describes it as a prodrug of 4-OH-DiPT, given as an injection under the skin." }, { "nct": "NCT00979693", "title": "Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma", "sponsor": "Multidisciplinary Association for Psychedelic Studies", "phase": "Phase 2", "status": "Withdrawn", "status_key": "withdrawn", "condition": "Anxiety in people with stage IV melanoma", "enrollment": "0 (actual)", "dates": "Start listed as January 2012; withdrawn before enrolling anyone", "fl_sites": "Mount Sinai Comprehensive Cancer Center, Miami Beach", "miami_area": true, "updated": "December 26, 2023", "url": "https://clinicaltrials.gov/study/NCT00979693", "note": "Withdrawn with no one enrolled: the registry says the lead investigator could not get his department's permission to submit the protocol to the local institutional review board." } ] }