As we reflect on the advancements of 2023, it’s clear that the field of psychedelics has entered a new era of recognition and potential. This year marked a series of unprecedented milestones that collectively signal a major shift in how we perceive, research, and utilize psychedelic substances for mental health. From groundbreaking legalizations to pioneering clinical trials, the past year has seen some of the most pivotal developments in the psychedelic landscape in decades and has set the tone for more milestones in 2024.
Australia’s Landmark Legalization of Psychedelics for Mental Health
In a historic move, Australia became the first country in the world to legalize the use of certain psychedelics for mental health treatment. This groundbreaking decision allows approved psychiatrists to prescribe MDMA for individuals suffering from Post-Traumatic Stress Disorder (PTSD) and psilocybin mushrooms for certain types of depression. This step represents a major shift in the perception and medical use of psychedelics, potentially opening doors for more research and application in mental health treatments.
The decision by the Australian Therapeutic Goods Administration (TGA) is a result of growing evidence supporting the efficacy of these substances in treating mental health conditions. Several clinical trials have demonstrated the potential of MDMA and psilocybin in providing relief where traditional treatments have failed, paving the way for this revolutionary change in Australian mental health care. Under the TGA guidelines, Australians may access and be prescribed MDMA in conjunction with therapy. However, as of December 2023, no MDMA prescriptions have been issued. (1)
MAPS and the FDA: Paving the Way for MDMA-Assisted Therapy
The Multidisciplinary Association for Psychedelic Studies (MAPS) submitted a new drug application to the U.S. Food and Drug Administration (FDA) for MDMA-Assisted Therapy for PTSD. If approved, this would mark a significant milestone, as MDMA would be rescheduled and become available for prescription medical use. This application is a culmination of years of research and clinical trials conducted by MAPS, demonstrating the potential of MDMA as a valuable tool in treating PTSD.
The approval of this drug application could transform the treatment landscape for PTSD, a condition that affects millions worldwide and is often resistant to conventional treatment methods. The rescheduling of MDMA would not only validate its therapeutic potential but also open avenues for further research and development in the field of psychedelic-assisted therapy. MAPS founder and executive director Rick Doblin has estimated that MDMA may receive FDA approval as early as November of 2024. (2)
Bipartisan Support in Congress for Psychedelic Research in the Military
A notable development in 2023 was bipartisan support in Congress, leading to legislation that directs the U.S. Defense Department to create grants for studying psychedelic treatments for active duty service members.
The initiative, spearheaded by Reps. Dan Crenshaw and Alexandria Ocasio-Cortez would authorize, fund, and direct the Department of Defense and the Department of Veterans Affairs to develop and issue grants for psychedelic studies involving active-duty military personnel and veterans. The establishment of these grants signifies a significant shift in the perception of psychedelics within government circles.(3)
Cybin’s Clinical Trials Strengthening the Case for Psilocybin
Organizations like Cybin have been at the forefront of conducting clinical trials to explore the efficacy of psilocybin mushrooms in treating major depressive disorder (MDD). These trials have continued to yield promising results, showing that psilocybin can offer substantial relief for individuals suffering from MDD. This ongoing research is crucial in building a robust body of evidence to support the therapeutic use of psilocybin (specifically Cybin’s CYB003 psilocybin derivative) and other psychedelics.
Significant Reduction in Depression Symptoms: A single dose of CYB003, a psilocybin-based therapy, showed a rapid and robust reduction in depression symptoms. A second dose provided an additional benefit, enhancing the treatment’s effectiveness.
Achievement of Primary Efficacy Endpoint: The study achieved its primary efficacy endpoint, showing a remarkable average decrease of 14 points in the Montgomery-Asberg Depression Rating Scale (MADRS) score from the baseline when comparing CYB003 (12mg) with a placebo.
High Remission Rates at 6 Weeks: Impressively, 79% of patients were in remission from depression after receiving just two doses of CYB003 (12mg). This was observed at the 6-week checkpoint, indicating sustained and effective treatment results.
Safety and Tolerability: The study reported a favorable safety and tolerability profile for CYB003. Notably, no serious adverse events related to the treatment were recorded at either 12mg or 16mg doses.
The success of these trials is paving the way for more widespread acceptance and potential regulatory approval of psilocybin as a treatment option, offering hope to millions who struggle with depression.(4)
Decriminalization of Entheogenic Plants and Fungi in U.S. Cities
Throughout 2023, cities across the United States, including Berkeley, California, and Portland, Maine, continued the trend of decriminalizing entheogenic plants and fungi. These local movements reflect a growing societal shift towards acknowledging the potential benefits of these substances and reducing the legal penalties associated with their use.
The decriminalization efforts by these cities are part of a larger movement advocating for a more progressive and science-based approach to drug policy, recognizing the therapeutic and spiritual value of entheogenic substances.(5)
State-Level Initiatives to Explore Psychedelics
State lawmakers in Arizona, Massachusetts, Minnesota, Nevada, and Washington took proactive steps by creating psychedelic task forces. These task forces are dedicated to studying the medical potential of psychedelics and exploring options for legalization. This reflects an increasing interest at the state level to understand and potentially integrate psychedelics into medical and therapeutic practices. The work of these task forces is crucial in shaping future policies and regulations surrounding psychedelics, potentially leading to more progressive and health-oriented approaches to their use.
Arizona’s Psilocybin Research Funding: The Governor of Arizona signed a law in May to fund research into the medical potential of psilocybin mushrooms for various conditions, and the Arizona Psilocybin Research Advisory Council met in December to allocate funding for this research.
Massachusetts’ Psychedelics Legalization Initiative: Massachusetts activists secured enough signatures in December to consider a psychedelics legalization initiative, aiming for the 2024 ballot. Additionally, Governor Maura Healey introduced legislation to form a working group to explore psychedelics’ therapeutic benefits, particularly for military veterans.
Minnesota’s Psychedelics Task Force: Minnesota’s Governor signed a bill to create a psychedelics task force, which met in November to prepare for potential legalization. The task force is tasked with providing recommendations on psilocybin, MDMA, and LSD by January 1, 2025, with plans for a reform bill to follow.
Nevada’s Psychedelic Medicines Working Group: In June, Nevada’s Governor signed a bill establishing a working group to study psychedelics and plan for regulated therapeutic access. Initially aiming to legalize psilocybin and promote MDMA research, the bill was modified to focus on studying the use of entheogens for medicinal and wellness purposes.
Washington State’s Psilocybin Research and Pilot Program: Washington State Governor Jay Inslee signed legislation in May to promote psilocybin research and establish a pilot program for therapeutic access, particularly for military veterans and first responders. The original bill proposing broader legalization was scaled back to focus on a task force and advisory group for reform study.(5)
Oregon’s Pioneering Psilocybin Service Centers
Oregon made history by opening the nation’s first legal psilocybin service centers, serving an estimated 700 people in 2023. These centers provide guided sessions with psilocybin, offering a regulated and safe environment for individuals seeking psychedelic experiences for therapeutic purposes. Oregon’s initiative serves as a model for other states and countries, showcasing the feasibility and benefits of regulated psychedelic therapy. The success of these centers is a testament to the growing acceptance of psychedelics as valuable tools in mental health treatment and could spur further advancements in the field. However, controversies regarding pricing, accessibility, and a shortage of both trained providers and service centers will need to be addressed as we move into the new year.(6)
Psychedelic Science 2023 Draws Over 10,000 Attendees
The Psychedelic Science 2023 conference, held in Denver, CO., represented a significant convergence of professionals from various fields related to psychedelic research and policy. As the largest gathering in this area, it featured a diverse range of panels, workshops, and lectures from key figures in the industry. The conference focused on the latest developments in psychedelic research, including clinical trial updates and discussions on the safety and efficacy of treatments. It also provided a platform for critical dialogue on the challenges facing the psychedelic industry, particularly the transition from a gray market to a legal one, navigating unclear regulations, and addressing the high costs and risks of operating in an untested space.
Moreover, the conference shed light on both the progress and hurdles in psychedelic policy reform at the state and federal levels. Discussions emphasized the importance of continued advocacy for future advancements in the field. The event also delved into microdosing research, exploring its effects and the role of belief in its efficacy. Additionally, it highlighted indigenous perspectives on psychedelic use and the impact of commercialization and democratization in the psychedelic movement. The gathering underscored the balance between the influx of capital into the psychedelics field and the need for equitable access and preservation of traditional knowledge.(7)
The year 2023 will undoubtedly be remembered as a watershed moment in the history of psychedelic research and policy. The developments we’ve witnessed this year reflect a growing consensus about the therapeutic potential of psychedelics and a shift towards more progressive, health-focused drug policies. As we look to the future, the groundwork laid in 2023 paves the way for continued exploration, understanding, and integration of psychedelic therapies into mainstream healthcare. This exciting journey, marked by scientific discovery and societal acceptance, promises to transform our approach to mental health and well-being in the years to come.
- Wertheimer, T. (2023, June 30). Australia legalizes psychedelics for mental health. BBC News. https://www.bbc.com/news/world-australia-66072427
- MAPS PBC Announces New American Medical Association CPT III Codes for Psychedelic-Assisted Therapies Take Effect | MAPS Public Benefit Corporation. (n.d.). Mapsbcorp.com. Retrieved January 3, 2024, from https://mapsbcorp.com/news/maps-pbc-announces-new-american-medical-association-cpt-iii-codes-for-psychedelic-assisted-therapies-take-effect/
- Choi, M. (2023, December 14). Congress greenlights psychedelic treatment bill for active duty service members suffering from PTSD. The Texas Tribune. https://www.texastribune.org/2023/12/14/ndaa-congress-psychedelics-ptsd-dan-crenshaw/
- Priyan, V. (2023, December 1). Cybin reports positive results from major depressive disorder trial. Clinical Trials Arena. https://www.clinicaltrialsarena.com/news/cybin-major-depressive-disorder-trial/?cf-view
- Psychedelics Legalization & Decriminalization Tracker. (n.d.). Psychedelic Alpha. https://psychedelicalpha.com/data/psychedelic-laws
- Oregonian/OregonLive, L. A. | T. (2023, December 19). Over 700 people used psychedelic mushrooms under Oregon’s program in 2023. Oregonlive. https://www.oregonlive.com/health/2023/12/over-700-people-have-used-psychedelic-mushrooms-under-oregons-program-in-2023.html
- Aldworth, B. (2023, March 10). Psychedelic Science 2023 Announces Initial Agenda and Select Featured Speakers for the Largest Gathering of Psychedelic Professionals in the Country. Multidisciplinary Association for Psychedelic Studies – MAPS. https://maps.org/2023/03/09/psychedelic-science-2023-announces-initial-agenda-and-select-featured-speakers-for-the-largest-gathering-of-psychedelic-professionals-in-the-country/