Psychedelic substances are being studied in drug development programs, with clinical trials showing evidence for safe and effective use of psychedelic therapies for mental health conditions. With anticipated FDA approval of MDMA-assisted therapy for PTSD in 2023 and psilocybin therapy for depression disorders soon after, the medical community should become informed on best practices and participate in developing standards of care. Gold standards in medicine distinguish treatments as the highest quality for comparison. This article reviews the origins of psychedelic-assisted therapy, minimum requirements for safe use, criteria for gold standards in mental health, and nuances in establishing gold standards in psychedelic medicine to guide clinical decision making.
MDMA-assisted therapy (MDMA-AT) can be scaled across multiple clinic sites while maintaining high treatment fidelity. In an open-label study across 14 North American sites, cotherapist dyads were trained in a manualized protocol and administered three experimental sessions to participants with severe PTSD. Adherence to the therapy protocol was high across both dyads and sites. PTSD symptom severity, measured by the CAPS-5, decreased substantially after three sessions at 18 weeks. MDMA was well tolerated. These results indicate that the benefits of MDMA-AT for PTSD can be achieved in a multi-site, real-world clinical setting.