What is needed for the roll-out of psychedelic treatments?
Stephen N. Xenakis, Scott Shannon
Current Opinion in Psychiatry July 1, 2024 DOI: 10.1097/YCO.0000000000000946 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Psychedelic-assisted therapy |
| Keywords | Mental health treatment Drug policy reform MDMA Research Clinical protocols |
| Citations | 5 |
| Key findings | Psychedelic treatments are rapidly entering mainstream medical care in the US, but a core philosophical disagreement over whether they are primarily pharmacological or psychotherapeutic limits the development of coherent clinical guidelines and regulation. |
Abstract
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? 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. 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.
Comparable studies
Other narrative reviews on psychedelic-assisted therapy, most cited first.
Citations in the library
Cited by 4
- Ethical Considerations Regarding Psychedelics for Clinical Pain Research. Journal of Pain Research 2024
- What motivates spiritual health practitioners in psychedelic-assisted therapy? A qualitative study and implications for facilitator training practices Psychedelics April 29, 2025
- Psychedelics in Multiple Sclerosis: Mechanisms, Challenges, and Prospects for Neuroimmune Modulation and Repair. Cells November 26, 2025
- Attitudes Toward Psychedelic-Assisted Therapies for Cancer-Related Psychosocial Symptoms: A Multi- Stakeholder Analysis Research Square August 19, 2025
Cites 11
- Studying Harms Is Key to Improving Psychedelic-Assisted Therapy—Participants Call for Changes to Research Landscape JAMA Psychiatry March 29, 2023
- Classic serotonergic psychedelics for mood and depressive symptoms: a meta-analysis of mood disorder patients and healthy participants Psychopharmacology January 11, 2021
- Research abuses against people of colour and other vulnerable groups in early psychedelic research Journal of Medical Ethics July 12, 2021
- Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial PLoS One February 25, 2022
- Psychedelic Therapy—A New Paradigm of Care for Mental Health JAMA August 31, 2023
and 6 more in the library