Psychedelic-assisted therapy: An overview for the internist.

Brian S Barnett, Erin E Mauney, Franklin King

Journal: Cleveland Clinic journal of medicine 2025;92(3):171-180

PMID: 40032306

Abstract

Preliminary evidence suggests that psychedelic-assisted therapy-the enhancement of psychotherapy with psychedelics such as 3,4-methylenedioxymethamphet-amine (MDMA) and psilocybin-may be efficacious for depression, posttraumatic stress disorder, substance use disorders, and other conditions. Therapeutic psychedelic research is advancing steadily, with psilocybin, MDMA, and lysergic acid diethylamide designated breakthrough therapies by the US Food and Drug Administration (FDA). However, in August 2024, the FDA declined to approve a New Drug Application for MDMA and asked its sponsor to conduct another phase 3 trial. Clinicians are urged to prepare for the possible return of psychedelics to medicine.

Copyright © 2025 The Cleveland Clinic Foundation. All Rights Reserved.

Address: Department of Psychiatry and Psychology, Cleveland Clinic, Cleveland, OH; Assistant Professor, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH; Principal investigator, Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD NCT05711940, and A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE) NCT06741228 [email protected].; Researcher, Center for Neurointestinal Health, Massachusetts General Hospital Division of Gastroenterology, Boston, MA; Assistant Professor, Pediatric Gastroenterology, Tufts Medical Center, Boston, MA; Co-investigator, Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS) NCT06206265.; Director, Training and Education, Center for Neuroscience of Psychedelics, Massachusetts General Hospital, Boston, MA; Instructor, Department of Psychiatry, Harvard Medical School, Boston, MA; Principal investigator, Assessment of Psilocybin (TRP-8802) in Concert With Psychotherapy in Patients With Irritable Bowel Syndrome (IBS) NCT06206265.

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