Psychedelic-assisted therapy: An overview for the internist
Franklin King, Brian S. Barnett, Erin Mauney
Cleveland Clinic Journal of Medicine March 1, 2025 DOI: 10.3949/ccjm.92a.24032 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Interventions | Psychedelic-assisted therapy MDMA Psilocybin Lysergic acid diethylamide |
| Topics | Psychedelic-assisted therapy |
| Keywords | Intensive care medicine |
| Citations | 11 |
| Key findings | 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.
Comparable studies
Other narrative reviews on psychedelic-assisted therapy, most cited first.
Citations in the library
Cited by 12
- Key competencies for psychedelic treatment in real-world mental health care settings. General Hospital Psychiatry 2025
- Consistency of protocol and safety data reporting in clinical trial registrations and corresponding publications of interventions involving MDMA and psilocybin. Journal of Clinical Epidemiology January 23, 2026
- Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty. The Journal of Law, Medicine & Ethics 2026
- With great power comes great responsibility: Promise and caution in the new psychedelic renaissance Brain Disorders September 23, 2025
- A Randomised, Triple-Blind, Dose-Finding Study of the Impact of Psilocybin on Motor Function in Healthy Participants medRxiv December 23, 2025
and 7 more in the library