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Psychedelic-assisted therapy: An overview for the internist
Brian S Barnett1, Erin E Mauney2, Franklin King3
1Department 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 barnetb3@ccf.org.
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.
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