FDA issues first draft guidance on psychedelic research
Mental Health Weekly June 30, 2023 DOI: 10.1002/mhw.33697 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Peer reviewed |
|---|---|
| Topics | MDMA Psilocybin |
| Keywords | Clinical trial Hallucinogen Pharmacology |
| Key points | The FDA issued draft guidance for clinical trials with psychedelic drugs, highlighting unique challenges in study design. |
Abstract
Observing that designing clinical studies to evaluate the safety and effectiveness of psychedelic substances presents a number of unique challenges that require careful consideration to the industry, the U.S. Food and Drug Administration (FDA) last month issued, for the first time, draft guidance for conducting clinical trials with psychedelic drugs such as psilocybin and MDMA (ecstasy).