AI Article Synopsis
- The review highlights the rapid growth of psychedelic treatments, particularly focusing on the lack of regulation and clear clinical guidelines amid a debate on whether these treatments are primarily pharmacological or psychotherapeutic.
- Recent advancements include Lykos's submission for FDA approval of MDMA-assisted psychotherapy for PTSD, Australia's endorsement of psilocybin and MDMA, and the legalization of psilocybin in Colorado and Oregon with varying regulations.
- There is a pressing need for established clinical guidelines to ensure safe and effective practices in psychedelic treatments as they become more integrated into medical care in the U.S.
Article Abstract
Purpose Of Review: The pace of psychedelic treatments continues to increase. Regulation and coherent clinical guidance have not been established. A philosophical divide limits effective resolution of a practice delivery quandary: is this primarily a pharmacological or psychotherapeutic intervention?
Recent Findings: Lykos (formerly MAPS) has submitted its new drug application (NDA) request to the FDA for 3-4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for PTSD and is expecting a response by the summer of 2024. Australia endorsed psilocybin and MDMA for regulated use in 2023. Multiple phase II and III clinical trials are also being conducted in the United States and Europe to study the use of psilocybin. Currently, Colorado and Oregon have legalized psilocybin in different manners. In Colorado, plants containing psilocybin, ibogaine, dimethyltryptamine (DMT) and mescaline (other than peyote) are now legal to possess, share and cultivate. Guidelines for regulated treatment with psilocybin containing mushrooms are in process with service delivery to begin early in 2025. In Oregon, clients must complete a preparation session with a licensed facilitator before consuming psilocybin products at a licensed service center. A prescription is not required. It is expected that other states will follow suit with a ballot measure likely in Massachusetts this year. Additionally, in the United States, the DEA, state boards, pharmaceutical distributors, and professional liability carriers all share mounting concerns about the in-home use of compounded ketamine used as a psychedelic therapeutic via remote prescribing.
Summary: Psychedelic treatments are rapidly entering the mainstream of medical care delivery in the United States. Clinical guidelines are urgently needed to ensure well tolerated practice and coherent regulation. The delivery of this guidance is limited by a core philosophical disagreement. Resolution of this conflict will be needed to deliver coherent clinical guidelines. Current research and clinical experience provide a solid foundation for practical clinical guidance and the introduction of psychedelics into healthcare.
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| http://dx.doi.org/10.1097/YCO.0000000000000946 | DOI Listing |
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