Issues in Clinical Trial Design—Lessons From the FDA’s Rejection of MDMA
This Viewpoint explores potential justifications underlying the US Food and Drug Administration (FDA)’s rejection of methylenedioxymethamphetamine (MDMA) as a treatment for posttraumatic stress disorder, including lack of blinding and issues around the integrity of relevant clinical trials.
Authors
- Samuel T. Wilkinson (ORCID: https://orcid.org/0000-0002-3483-9168)
- Gerard Sanacora (ORCID: https://orcid.org/0000-0003-3722-8829)
Institutions
- Yale University (US)
Publication Details
- Journal
- JAMA Psychiatry
- Published
- 2025-04-16
- DOI
- https://doi.org/10.1001/jamapsychiatry.2025.0442
- Citations
- 9
- Primary Topic
- Pain Management and Placebo Effect
- Type
- article
- Field-Weighted Citation Impact
- 12.88