Psychedelic-assisted therapy: An overview for the internist
Cleveland Clinic Journal of Medicine – March 01, 2025
Source: OpenAlex
Summary
Compelling preliminary evidence suggests psychedelic-assisted therapy, influencing neurotransmitter receptor activity, holds promise for conditions like depression and PTSD. These Psychedelics and Drug Studies, involving compounds like MDMA and psilocybin, have earned breakthrough therapy designations. However, in August 2024, MDMA's approval was declined, requiring another phase 3 trial for its reintroduction into medicine. This rigorous process highlights the careful evaluation. Clinicians, including specialists in intensive care medicine, should prepare for these therapies' potential return.
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.