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3 hours ago
As interest in psychedelic-assisted therapies (PATs) grows, so does the need for clearer safety guidelines. Psychedelic treatments using substances like psilocybin, LSD, and MDMA are being explored for mental health issues like depression and PTSD, showing promising results. The FDA has granted breakthrough therapy status to some, but its recent rejection of MDMA for PTSD due to safety concerns highlights the need for standardized assessments of adverse events (AEs) in these therapies.
While research has largely focused on their benefits, assessing the risks and AEs related to these therapies has not been as thorough. A new framework published in the Journal of Psychopharmacology seeks to change that, introducing a comprehensive approach for identifying, monitoring, and reporting potential negative effects specific to psychedelic therapies.
The Need For Tailored Adverse Event Reporting
Psychedelic-assisted therapies are different from traditional treatments because they combine the effects of powerful psychedelic substances with psychotherapy. This combination can lead to unique experiences such as intense visual effects, spiritual insights, and deep psychological changes that standard safety assessments often overlook. Current guidelines for reporting side effects in clinical trials, like those in the Medical Dictionary for Regulatory Activities, may not fully capture ...
