240
Participants
Start Date
March 13, 2024
Primary Completion Date
April 30, 2026
Study Completion Date
December 30, 2026
Psilocybin 25 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Psilocybin.
Inactive Placebo
The inactive placebo is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of Microcrystalline Cellulose (MCC). The MCC is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use.
Psilocybin 5 mg
The Psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active comparator is encapsulated within a hydroxypropyl methylcellulose (HPMC) capsule and contains 5 mg of Psilocybin.
Psychosocial Support
Psychosocial Support, including psychoeducation, begins after the Double-blind Period and continues throughout the 1-year Follow-up Period in order to enhance participant safety and maximize retention for the entire trial duration.
RECRUITING
NYU Clinical & Translational Science Institute, New York
RECRUITING
Bronx Veterans Research Foundation at the James J. Peters VAMC, The Bronx
WITHDRAWN
Scranton Medical Institute, LLC, Moosic
ACTIVE_NOT_RECRUITING
Sunstone Medical PC, Rockville
RECRUITING
Johns Hopkins School of Medicine, Center for Psychedelic and Consciousness Research, Baltimore
RECRUITING
CenExel iResearch, LLC, Decatur
RECRUITING
Emory University, Atlanta
RECRUITING
Clinical Neuroscience Solutions Inc., Jacksonville
RECRUITING
Clinical Neuroscience Solutions, Inc., Orlando
RECRUITING
Innovative Clinical Research, Inc., Lauderhill
RECRUITING
University of Alabama Clinical Research Unit, Birmingham
RECRUITING
Great Lakes Clinical Trials, Chicago
RECRUITING
Washington University School of Medicine, St Louis
RECRUITING
VA Nebraska Western Iowa Health Care System, Omaha
RECRUITING
Preferred Research Partners, Inc., Little Rock
TERMINATED
Preferred Research Partners-NWA, LLC, Fayetteville
RECRUITING
AIM Trials, LLC, Plano
RECRUITING
Clinical Trials of Texas, LLC, San Antonio
RECRUITING
Mountain View Clinical Research, Denver
ACTIVE_NOT_RECRUITING
Cedar Clinical Research, Draper
RECRUITING
Cedar Clinical Research, Inc., Murray
RECRUITING
University of New Mexico (UNM) Interdisciplinary Substance Use and Brain Injury (ISUBI) Center, Albuquerque
RECRUITING
West LA VA Medical Center - Mental Health Department, Los Angeles
TERMINATED
Pacific Neuroscience Institute (PNI) at Saint John's Physician Partners, Santa Monica
RECRUITING
Psychedelic Science Institute, Santa Monica
RECRUITING
Kadima Neuropsychiatry Institute, La Jolla
RECRUITING
Seattle Neuropsychiatric Treatment Center, Bellevue
RECRUITING
VA Portland Health Care System, Vancouver
RECRUITING
Connecticut Mental Health Center, Yale University, New Haven
RECRUITING
Global Medical Institutes, LLC; Princeton Medical Institute, Princeton
Usona Institute
OTHER