In this week’s Psychedelic News Roundup, we examine a new study powered by the psychedelic experiences of Reddit users. Other news includes a new partnership between atai Life Science and Beckley Psytech, clarifying comments from the FDA, and MAPS’s new treatment codes for psychedelic-assisted therapy.
Study Explores Psilocybin’s Impact on Self-Perception and Recognition
Originally run by PsyPost, a recent study published in the Journal of Psychedelic Studies has shed light on how psilocybin, the psychedelic component in magic mushrooms, alters self-perception and recognition. Conducted by researchers from Montclair State University and led by Sam Elias, the study analyzed online Reddit posts to understand the experiences of individuals who looked into a mirror while under the influence of psilocybin.
Psilocybin is known for its profound effects on consciousness, perception, and awareness. However, its specific impact on self-perception (how one views oneself) and self-recognition (the ability to identify oneself correctly in a mirror) has yet to be extensively studied. This research aimed to fill that gap by examining personal accounts from Reddit users.
The researchers identified 486 relevant posts, out of which 89 met the inclusion criteria, and were further analyzed. These posts were divided into 15 different categories based on the content and tone, focusing on experiences related to self-perception and recognition.
The study revealed diverse experiences among psilocybin users. The most common categories included “visual change” (changes in visual perception), “self” (general discussions about the self), and “cognitive change” (alterations in thoughts and beliefs). Interestingly, the study found no significant difference in the “real self” (correct self-recognition) and “unreal self” (incorrect self-recognition), suggesting that psilocybin does not consistently impair self-recognition.
However, a significant difference was noted between “positive affect” and “negative affect” in self-perception, indicating that psilocybin tends to enhance positive self-perception. Less frequent categories included “aging” (perceiving oneself as older or younger) and “animal/entity” (seeing oneself as a non-human entity).
The findings challenge the common belief in psychedelic communities that looking into a mirror while under the influence of psilocybin should be avoided. The statistical significance of positive experiences compared to negative ones suggests that this lore may not be entirely accurate.
The study acknowledges limitations, such as the reliance on self-reported Reddit posts, which may not represent the broader population of psilocybin users. Future research could employ more controlled and experimental methods to further explore psilocybin’s effects on self-perception and recognition using mirrors.
The study, “Self-perception and self-recognition while looking in the mirror on psilocybin,” provides valuable insights into the subjective experiences of psilocybin users and contributes to the growing body of research on psychedelic substances and their impact on the human mind.(1)
atai Life Sciences Invests $50 Million in Beckley Psytech for Psychedelic Drug Development
Reported via Psychedelic Alpha, atai Life Sciences, a NASDAQ-listed psychedelic drug developer, has announced a significant $50 million strategic investment in Beckley Psytech, a British privately-held peer. This collaboration, detailed in SEC filings dated January 3rd, provides atai Life Sciences with exposure to Beckley Psytech’s primary clinical programs, including its intranasal 5-MeO-DMT candidate (BPL-003) and intravenous psilocin (ELE-101).
BPL-003 is under development for the treatment of treatment-resistant depression (TRD) and alcohol use disorder (AUD), currently in a Phase IIb study targeting 225 moderate-to-severe TRD patients. Topline results for this study are expected in the second half of 2024. ELE-101, designed for major depressive disorder (MDD), is in a Phase I/IIa study, with results anticipated in the first half of 2024.
During a conference call, atai CEO Florian Brand, emphasized the potential of these candidates to demonstrate efficacy in a more scalable manner compared to longer-duration therapies like MDMA– or psilocybin-assisted treatments. Christian Angermayer, atai’s founder and chairman, highlighted the importance of short-duration psychedelics, which could offer similar clinical benefits to longer-acting psychedelics in a more efficient way, potentially increasing patient access.
Beckley Psytech CEO, Cosmo Feilding Mellen, expressed excitement about joining forces with atai to develop rapid-acting psychedelic medicines for people in need. The collaboration may also extend to developing digital tools to optimize patient support and future commercialization plans.
This investment reinforces atai’s position as a biopharmaceutical company with a diverse portfolio of clinical-stage psychedelic candidates. It also signals atai’s continued exploration of a decentralized model of drug development, focusing on equity investments in promising psychedelic therapies.
The investment includes a $40 million direct investment into Beckley Psytech and an additional $10 million in secondary share purchases from existing shareholders. This grants atai a 35.47% stake in Beckley Psytech and three of its nine board seats, atai also secures a time-limited right of first refusal on any future sale of Beckley Psytech or its assets and an indefinite right of first negotiation regarding BPL-003 and ELE-01.
This strategic move by atai Life Sciences marks a significant step in consolidating its presence in the psychedelic drug development sector, expanding its pipeline, and strengthening its position in the industry.(2)
Cybin Reports Promising Results for Psychedelic-Based Therapies
Cybin Inc., a clinical-stage biopharmaceutical company, has made significant strides in developing psychedelic-based treatments for mental health conditions. The company recently announced positive Phase II topline data for its Major Depressive Disorder (MDD) treatment using CYB003, a deuterated psilocybin analog. The results were highly promising, with 79% of patients in remission from depression after receiving two doses of CYB003 (12mg).
Supported by a robust intellectual property portfolio comprising 40 granted patents and over 170 pending applications, Cybin’s advancements are gaining momentum. The company is preparing for a multinational Phase III trial of CYB003 in MDD and a Phase II study of deuterated dimethyltryptamine (dDMT) in Generalized Anxiety Disorder (GAD) in early 2024. Phase I readouts for deuterated DMT (CYB004/SPL028) are in the final analysis stage.
Doug Drysdale, CEO of Cybin, highlighted the importance of these developments, noting that the upcoming first quarter of 2024 would be crucial for advancing the company’s clinical programs. Cybin plans to initiate a Phase III trial for CYB003 in MDD and begin a Phase II trial of CYB004 in GAD.
The Phase II results for CYB003 showed substantial improvements in depression symptoms after single doses and a significant remission rate. The safety profile of CYB003 was excellent, with all reported adverse events being mild to moderate and self-limiting. Upcoming milestones for the CYB003 program include additional Phase II data assessing the durability of efficacy at 12 weeks and an FDA end-of-Phase II meeting in early 2024.
Cybin’s DMT program, which includes proprietary psychedelic molecules CYB004, SPL028, and SPL026, represents one of the most advanced and extensive DMT datasets in psychedelic drug development. The program’s highlights include multiple clinical trials providing proof-of-concept for DMT/dDMT assets, such as Phase IIa safety and efficacy for SPL026 in MDD and a Phase Ib study evaluating the safety and efficacy of SPL026 in conjunction with SSRIs.(3)
The DEA Clarifies Legality of Psilocybin Spores
Coming to us from Marijuana Moment, the Drug Enforcement Administration (DEA) has clarified that spores of psilocybin mushrooms are not federally illegal on their own. In response to an inquiry by attorney Michael McGuire, Terrence Boos, the DEA’s Drug & Chemical Evaluation Section Chief, stated that unless these spores contain psilocybin, psilocin, or any other controlled substance, they are not considered controlled under the Controlled Substances Act (CSA). This clarification confirms the long-standing understanding that mushroom spores themselves are legal, as they do not contain psilocybin or psilocin, the psychoactive compounds that are classified as Schedule I controlled substances.
However, Boos emphasized that if these materials come to contain psilocybin or psilocin at any point, such as upon germination, they would then be regarded as controlled substances. While the spores are technically legal federally, states like California, Georgia, and Idaho have their own laws prohibiting them.
This distinction by the DEA highlights an important legal nuance. Although the spores are legal, the production of mushrooms containing psilocybin or psilocin from these spores would be illegal. Additionally, there’s a question of whether spore kits could be considered “drug paraphernalia,” depending on how they are marketed or used.
This clarification, though not entirely new, is significant as police have arrested individuals for selling or using spore kits in the past. It suggests a nuanced approach to the legality of substances and materials related to psychedelic mushrooms and highlights the complexity of drug laws in the United States. Despite this clarification, the widespread sale and use of spore kits remain legally ambiguous, and individuals involved in such activities should understand the legal issues with a lawyer and act accordingly.(4)
MAPS Files New Treatment Codes for Psychedelic-Assisted Therapies
Announced via PRNewswire, MAPS Public Benefit Corporation (MAPS PBC), a clinical-stage company focused on transforming mental health treatment, revealed that the American Medical Association (AMA) has now implemented the current procedural terminology (CPT) III codes for psychedelic-assisted therapies. These codes, which were first announced in July 2023, are designed to provide physicians and other qualified healthcare providers with a means to seek coverage and reimbursement for delivering psychedelic-assisted therapy, should it receive approval from the U.S. Food and Drug Administration (FDA).
In December 2023, MAPS PBC submitted a new drug application (NDA) to the FDA for MDMA (midomafetamine capsules) to be used in conjunction with psychological interventions, including psychotherapy, for individuals with post-traumatic stress disorder (PTSD). The implementation of these new CPT III codes marks an important advancement for the potential future use of MDMA-assisted therapy if approved by the FDA. Amy Emerson, CEO of MAPS PBC, emphasized the significance of establishing a reimbursement pathway for both the medication and associated therapy sessions.
The new CPT III codes are temporary and are assigned to emerging technologies, services, and procedures to facilitate reimbursement and support access to psychedelic therapies in the United States, pending FDA approval. The codes are also meant for data collection to substantiate usage, which could lead to their conversion to permanent CPT I codes with assigned valuations for widespread coverage and reimbursement. In collaboration with COMPASS Pathways, MAPS PBC worked with the AMA to create these codes. The codes include one for a healthcare professional to be reimbursed for monitoring and intervention during psychedelic-assisted therapy, with additional modifiers for a second healthcare professional and clinical staff.
MDMA has been granted Breakthrough Therapy designation by the FDA in 2017, and MAPS PBC has requested the FDA grant Priority Review of the NDA. The FDA’s decision on the review status (priority or standard) is expected within 60 days of the NDA submission. If MDMA-assisted therapy is approved by the FDA, the DEA would need to reschedule MDMA to make it available for prescription medical use. However, the safety and efficacy of MDMA-assisted therapy have not been established for PTSD treatment and are still awaiting regulatory approval.(5)
Fresh, crowd-sourced research, major partnerships, and advancements in research mark the first week of 2024 as an already impressive and exciting time for the emerging psychedelic field. As we move into the new year, we expect to see increasingly important and critical announcements and developments in psychedelic research, novel medical treatments, and the ever-shifting tide of public opinion.
- Setionago, B. (2024, January 3). Exploring the psychedelic mirror: How psilocybin alters self-perception. PsyPost. https://www.psypost.org/2024/01/exploring-the-psychedelic-mirror-how-psilocybin-alters-self-perception-220458
- atai Life Sciences Makes $50m Investment in Beckley Psytech. (2024, January 4). Psychedelic Alpha. https://psychedelicalpha.com/news/atai-life-sciences-makes-50m-investment-in-beckley-psytech
- Cybin – Cybin Highlights Recent Topline Results and Outlines Key Upcoming Milestones Across its Clinical Development Programs. (n.d.). https://ir.cybin.com/investors/news/news-details/2024/Cybin-Highlights-Recent-Topline-Results-and-Outlines-Key-Upcoming-Milestones-Across-its-Clinical-Development-Programs/default.aspx
- Jaeger, K. (2024, January 4). DEA confirms that psychedelic mushroom spores are federally legal prior to germination – marijuana moment. Marijuana Moment. https://www.marijuanamoment.net/dea-confirms-that-psychedelic-mushroom-spores-are-federally-legal-prior-to-germination/https://doi.org/10.1111/jmwh.13371
- MAPS Public Benefit Corporation. (2024, January 2). MAPS PBC Announces New American Medical Association CPT III Codes for Psychedelic-Assisted Therapies Take Effect. PRNewswire. https://www.prnewswire.com/news-releases/maps-pbc-announces-new-american-medical-association-cpt-iii-codes-for-psychedelic-assisted-therapies-take-effect-302024227.html