Psychedelic-assisted therapy: An overview for the internist
Franklin King, Brian S. Barnett, Erin E. Mauney
Cleveland Clinic Journal of Medicine March 1, 2025 DOI: 10.3949/ccjm.92a.24032 via OpenAlex
Summary
AI-generated from the abstractPsychedelic-assisted therapy, using substances like MDMA and psilocybin, shows preliminary efficacy for depression, PTSD, and substance use disorders. Psilocybin, MDMA, and LSD have been designated breakthrough therapies by the FDA. However, in August 2024, the FDA declined to approve MDMA and requested an additional phase 3 trial. Clinicians should prepare for the possible return of psychedelics to medicine.
Study at a glance
| Characteristics | Review Peer reviewed |
|---|---|
| Interventions | Psychedelic-assisted therapy MDMA Psilocybin Lysergic acid diethylamide |
| Keywords | Intensive care medicine |
| Citations | 11 |
| Key finding | Psychedelic-assisted therapy may be efficacious for several conditions, but the FDA declined to approve MDMA in 2024 and requested another phase 3 trial. |
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.