A brief overview of naturalistic research and rising concerns related to future patient accessibility.
In my previous post, in this series centered around “Pharmaceutical inequalities”, I wrote about my experience working at an ibogaine clinic in Mexico. I shared that the seven-day program I developed there integrated individual counseling, group therapy, psychoeducation modules, relapse prevention education, art therapy practices, self-compassion journaling exercises, goal planning for after-care , and a 5-MeO-DMT therapy session; and that a future post would address the emerging use of 5-MeO-DMT as a mental health tool. In this second post, I am setting out to do just that.
5-methoxy-N,N-dimethyltryptamine(5-MeO-DMT), is a naturally occurring psychedelic substance that is structurally similar to serotonin and melatonin and has been found in numerous plant species including Phalaris grass, Anadenanthera peregrina seeds, the resin from the Virola Theodora tree, and in large quantities in the defense secretions of a unique species of toad endemic to the Sonoran desert: Incilius alvarius (formerly Bufo alvarius) (Uthaug et al., 2019), also known as the Colorado river toad or the Sonoran desert toad.
I first learned about 5-MeO-DMT being present in the toad’s defense secretions in October 2008. An acquaintance had gifted me a book about the Amazonian psychedelic concoction called “Ayahuasca” titled “Cosmic Serpent: DNA and the Origins of Knowledge”, written by anthropologist Jeremy Narby. While reading the book, I became fascinated with one of the ingredients present in Ayahuasca, N, N-dimethyltryptamine(DMT). I began looking up information about DMT online and stumbled upon a very obscure and now nonexistent website called “The Deoxyribonucleic Hyperdimension”, better known as “deoxy.org”. Although the website went dark some time ago, I was able to find this website, which serves as a deoxy mirror and has a lot of the information the original deoxy.org website had. In the words of the person who created that deoxy mirror… (deoxy.org) “was a legendary part of the internet. It was one of the first websites available for people to read materials and ideas that were very hard to find at the local library”.
Somehow, clicking from link to link within the Deoxy Hyperdimension, I came across a pamphlet titled: “Bufo alvarius: The Psychedelic Toad of the Sonoran Desert”. Published in 1983 by a man who we now know was named Ken Nelson, the pamphlet was published under the pseudonym “Albert Most,” and it included accurate scientific information one would need to safely collect toad secretions and partake of toad-extracted 5-MeO-DMT.
I was pleasantly surprised when I discovered this pamphlet in 2008 and realized I was well acquainted with this toad species. Having been born and raised in Sonora, Mexico, where the toad is endemic to, I grew up seeing them summer after summer around my neighborhood in the city of Hermosillo. But it wasn’t until 2013 that I began to explore 5-MeO-DMT’s potential therapeutic application in the pilot program I implemented at the ibogaine treatment center I have been describing. What inspired my rationale for integrating the use of 5-MeO-DMT in the context of an ibogaine treatment was the fact that experience reports from ibogaine I was coming across, often described the experience as “harsh” or “stern”, while the early emerging reports from 5-MeO-DMT 10 years ago from people in my hometown, including family members, reported the experience along the lines of words like “love” and “universal connection”. Furthermore, the changes I began to witness in some of my family members and friends with regards to health behaviors (i.e., nutrition, exercise), compelled me to think that it could perhaps have a similar salubrious effect in other people too. So, I wondered what could happen if people in early recovery who just experienced ibogaine, could have access to a carefully curated 5-MeO-DMT experience?
As it turns out, over the following three years, I came to see that this sequential treatment approach appeared to be quite effective for this population. In the integration circles at the end of the program, participants would share things like “ I feel that the ibogaine fixes you, while 5-MeO-DMT heals you”. Months after the experience program participants would write me and say things like:
“The sense of connectedness, clarity and perspective that the 5-MeO-DMT experience gave me changed my outlook on life entirely. I am now much less self-centered, and that is because I now view all life as one and that inclusive feeling takes me out of myself. I am more appreciative of nature, and also far less afraid of death or the afterlife.”
Seeing and hearing the positive effects patients were reporting week after week, and often months and even years after their one-time experience, motivated me to pursue graduate school to research this therapeutic potential in a more rigorous way, advocate for synthetic 5-MeO-DMT use, and to connect with an interdisciplinary team of experts to explore avenues for toad conservation and protection in its endemic habitat.
Over the past 10 years, use of 5-MeO-DMT has become explosively popular, in good part I believe, due to a fabricated narrative of ceremonial/ancestral use use of the toad’s secretions by the Seri (Comcáac) tribe of Sonora. This narrative was deliberately introduced in 2012 in the Seri community of Punta Chueca, Sonora, and has been indiscriminately propagated thru various media outlets including Vice since then.
The huge increase of interest and demand this media attention has generated has in turn raised concerns about the toad’s ecological status among biologists, herpetologists, ecologists and human ecologists like me, who, in light of extractive and exploitative practices that have been developing in recent years, driven by the high demand of the toad secretions around the world, believe that the current classification of the toad species as one of “least concern” in the International Union for the Conservation of Nature (IUCN) Red List may no longer be accurate. In a future post, I will address how organizations such as Femtheogen Collaborative, and the Indigenous Medicine Conservation Fund are working together with researchers at the UW-Madison, and Mexico’s National Autonomous University, to carry out a large-scale toad population study, with the end goal of updating the toad’s ecological status in the IUCN Red List to inform future toad conservation efforts. For now, let us keep our focus on 5-MeO-DMT itself.
Compared to other psychedelics, the phenomenology of 5-MeO-DMT has been reported as intense and distinct, but without visual effects(Ermakova et al., 2022). The 5-MeO-DMT subjective experience is often described as transcendent, involving elements of “mystical-type” experiences, ego dissolution and nondual awareness, and an increased range of emotions from awe, love, and unity to panic and terror(Ermakova et al., 2022). A somatic response ranging from release in muscle tension, shaking or trembling to primal screaming, dancing (or even running) can also accompany the experience.
While to date, only one clinical research study with 5-MeO-DMT has been published (Reckweg et al., 2021), over the past five years, various naturalistic (i.e., use in non-clinical research settings) and observational studies have been published. For example, Dr. Alan Davis and his colleagues conducted a cross-sectional survey study on the epidemiology of 5-MeO-DMT and found that many respondents reported unintended improvements in anxiety, depression, substance misuse and posttraumatic-stress disorder symptoms following 5-MeO-DMT use in naturalistic settings (Davis, et al, 2018; Davis et al., 2019).
An observational study conducted by Dr. Malin Uthaug and her colleagues showed that a single administration of 5-MeO-DMT was related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrease of psychopathological symptoms (Uthaug, et al., 2019).
A retrospective survey study carried out by Dr. Alan Davis and team among a sample of US Special Operations Forces Veterans with severe symptoms of posttraumatic stress, and comorbidities associated with traumatic brain injury (i.e., depression, suicidal ideation), that completed the ibogaine/5-MeO-DMT treatment protocol at the treatment center I have been describing, showed that this multimodal approach resulted in significant and very large reductions in reports of suicidal ideation, cognitive impairment, symptoms of posttraumatic stress disorder, depression, and anxiety (Davis et al., 2020).
Further, a more recent study that was conducted with a different sample of US Special Operations Forces Veterans participating in the same ibogaine/5-MeO-DMT Mexico program, conducted again by Dr. Davis and his team showed there were significant and very large reductions in retrospective reports of alcohol misuse and posttraumatic stress symptoms from before to-after the multimodal psychedelic treatment (Mangini et al., 2021). The authors report that in the 30 days post treatment, 85% of program participants reduced their alcohol consumption to non-risky levels, suggesting that indeed 5-MeO-DMT may hold therapeutic potential as a treatment for substance misuse concerns.
In light of these preliminary findings, interest in researching 5-MeO-DMT and to develop it as an FDA-approved treatment has been growing exponentially in the last few years. Because 5-MeO-DMT induces a much shorter duration of acute phenomenological effects than psilocybin, (~20-60 minutes depending on the route of administration as opposed to ~6-8 hours for psilocybin) it is uniquely attractive to investors who question the commercial and practical potential of compounds that induce considerably longer-lasting psychedelic states. As a result, at present time numerous entities are filing for patents related to 5-MeO-DMT globally in order to maximize profit potential.
As of 4/12/2022, there were 76 total 5-MeO-DMT patents in the Porta Sophia database, a nonprofit psychedelic prior art library comprised of a group of researchers and legal professionals who track and evaluate patents in the psychedelic space in order to determine priorities for intervention at the prior art search stage of the patent prosecution process to help ensure patient accessibility is not compromised in the future (Porta Sophia, 2022). These attempts to patent 5-MeO-DMT represent a distinct threat to future accessibility of effective therapeutic treatments for diverse populations. We will delve deeper into this issue of patient accessibility, and other concerns related to pharmaceutical inequalities in a future post that will address the work of the Indigenous Medicine Conservation Fund, an organization that is centering the voices of indigenous peoples in the midst of the psychedelic renaissance currently unfolding.
References cited:
Davis, A. K., Barsuglia, J. P., Lancelotta, R., Grant, R. M., & Renn, E. (2018). The epidemiology of 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT) use: Benefits, consequences, patterns of use, subjective effects, and reasons for consumption. Journal of Psychopharmacology, 32(7), 779–792. https://doi.org/10.1177/0269881118769063
Davis, A. K., So, S., Lancelotta, R., Barsuglia, J. P., & Griffiths, R. R. (2019). 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety. The American Journal of Drug and Alcohol Abuse, 45(2), 161–169. https://doi.org/dakic
Davis, A. K., Averill, L. A., Sepeda, N. D., Barsuglia, J. P., & Amoroso, T. (2020). Psychedelic Treatment for Trauma-Related Psychological and Cognitive Impairment Among US Special Operations Forces Veterans. Chronic Stress, 4, 2470547020939564. https://doi.org/10.1177/2470547020939564
Ermakova, A. O., Dunbar, F., Rucker, J., & Johnson, M. W. (2022). A narrative synthesis of research with 5-MeO-DMT. Journal of Psychopharmacology, 36(3), 273–294. https://doi.org/10.1177/02698811211050543
Mangini, P., Averill, L. A., & Davis, A. K. (2021). Psychedelic treatment for co-occurring alcohol misuse and post-traumatic stress symptoms among United States Special Operations Forces Veterans. Journal of Psychedelic Studies, 1(aop). https://doi.org/10.1556/2054.2021.00176
Reckweg, J., Mason, N. L., van Leeuwen, C., Toennes, S. W., Terwey, T. H., & Ramaekers, J. G. (2021). A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers. Frontiers in Pharmacology, 12, 3340. https://doi.org/10.3389/fphar.2021.760671
Uthaug, M. V., Lancelotta, R., van Oorsouw, K., Kuypers, K. P. C., Mason, N., Rak, J., Šuláková, A., Jurok, R., Maryška, M., Kuchař, M., Páleníček, T., Riba, J., & Ramaekers, J. G. (2019). A single inhalation of vapor from dried toad secretion containing 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms. Psychopharmacology. https://doi.org/10.1007/s00213-019-05236-w
Editor’s Note: The Pharmaceutical Inequalities series is funded by the Holtz Center and the Evjue Foundation.