Psychedelic-assisted therapy: An overview for the internist

Abstract

Preliminary evidence suggests that psychedelic-assisted therapy—the enhancement of psychotherapy with psychedelics such as 3,4-methylenedioxymethamphetamine (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.