The recent decision by the US Food and Drug Administration (FDA) to withhold approval for MDMA-assisted psychotherapy (MDMA-AT) has sent ripples of disappointment and frustration throughout the scientific, psychedelic and therapeutic communities. This decision, issued via a Complete Response Letter to Lykos Therapeutics, effectively delays access to a promising treatment for millions of patients suffering from Post-Traumatic Stress Disorder (PTSD) by years. At OPEN, we feel compelled to express our concerns, while also proposing a path forward: one that emphasizes both rigorous scientific validation and compassionate pragmatism.
Disappointment in the FDA’s Decision to Restrict Access to Mdma-at
The FDA’s decision represents a significant setback for those advocating innovative approaches in mental healthcare. MDMA-AT has shown remarkable potential in treating PTSD, a condition that remains notoriously difficult to treat with existing therapies. The evidence presented by MAPS (Multidisciplinary Association for Psychedelic Studies) and Lykos Therapeutics (formerly MAPS PBC) demonstrates substantial improvements in PTSD symptoms among patients treated with MDMA-AT. These findings are not only statistically significant but also clinically meaningful, offering hope to those for whom traditional therapies have failed.
The FDA’s decision, while ostensibly rooted in a commitment to safety and efficacy, ultimately restricts access to a treatment that could transform and even save lives. For patients who have exhausted all other options, this decision feels like a denial of hope.
Surprise at the Divergence from the Dutch State Committee Report “Beyond Ecstasy”
What is particularly surprising is the stark contrast between the FDA’s decision and the conclusions reached by the Dutch State Committee on MDMA. Based on the same body of evidence, the Dutch committee (consisting of scientists, psychiatrists, legal experts, drug prevention and harm reduction specialists) arrived at a radically different conclusion: MDMA-AT is promising, effective, relatively safe and warrants more scientific research to further explore its therapeutic potential.
The committee even concluded that based on the relatively low potential for harm, MDMA could be down-scheduled: moving the compound from List 1 to List 2 of the Opium Act. Finally, the Committee advised the Dutch government to start a naturalistic study to allow patients access to this new therapy form, while also allowing scientists to collect more data on an ongoing basis, all the while gaining important clinical experience in delivering this novel treatment form. These diverging perspectives raise important questions about the interpretation of scientific data and the role of cultural and institutional factors in regulating novel therapeutic approaches.
The Dutch committee’s recommendation reflects a nuanced understanding of both the risks and benefits associated with MDMA-AT. They recognize that while methodological and ethical concerns remain, the potential therapeutic benefits of MDMA-AT cannot be ignored. This discrepancy between the FDA and the Dutch committee highlights the need for international dialogue and collaboration in the evaluation of novel therapies.
Want to learn more about the Dutch State Committee Report? Click here.
Acknowledging Methodological Concerns In MDMA Assisted Psychotherapy
At the moment, the specific reasons why the FDA rejected the approval of MDMA-AT are not yet publicly available, but we presume these concerns are likely based on the report from the FDA’s scientific advisory panel. These concerns are not without merit. The methodological issues raised, particularly those related to expectancy and placebo effects, are valid and warrant careful consideration. In randomized controlled trials (RCTs), both the MDMA and control groups have shown dramatic improvements, raising the possibility that nonspecific factors may be contributing to the observed outcomes. The contribution of these nonspecific factors to treatment outcomes is not unique to MDMA-AT, but is of concern in the evaluation of any psychoactive medicine. It is also crucial to note that the magnitude of improvement in the MDMA group far exceeds that of the control group, suggesting that the effects of MDMA-AT are not merely due to placebo or breaking blind. Placebo effects, while powerful, tend to diminish over time, whereas the benefits of MDMA-AT have been sustained in many cases. This durability is a critical factor in assessing the therapeutic potential of MDMA and underscores the need for further research to refine our understanding of its mechanisms of action.
Questions that need to be addressed
In our view, specific open questions that need to be addressed in future research include:
Role of Expectations: What is the role of patient expectations in the therapeutic benefits associated with MDMA-AT?
Blinding Integrity: How many participants are able to accurately guess their treatment assignment, and how does this impact the study outcomes?
Prior Experience with MDMA: Does the therapy work equally well for patients with and without prior experience with MDMA?
Control Conditions: Could alternative control conditions with experiential components, such as breathwork, be equally effective as MDMA in improving PTSD symptoms?
Non-Responders: What are the characteristics of patients who do not respond well to MDMA-AT, and how can their outcomes be improved?
Therapist-Client Interactions: What checks and balances are necessary to ensure the standardization and careful conduct of therapist-client interactions in MDMA-AT?
Proper aftercare:How can we ensure appropriate, sensitive, and durable aftercare for patients who may struggle for a substantial period after having undergone MDMA-AT (or placebo-assisted therapy)?
These questions highlight the need for further evaluating the efficacy of MDMA-AT and underscore the need for open science practices, including transparent reporting and rigorous study designs, to address these issues.
Addressing Ethical Concerns
Ethical concerns surrounding MDMA-AT are significant and need to be taken very seriously, particularly regarding the risks related to boundary violations. We are acutely aware of the need for rigorous training, careful monitoring and adequate supervision of both therapists and patients involved in MDMA-AT. This is particularly true when these therapies do become approved, and will be rolled out at a large scale, to more diverse groups of patients. The therapy should only be conducted in controlled environments by qualified professionals who adhere to the highest standards of care. This includes official oversight of relevant professional associations, ideally with a thorough understanding of the nature of – and specific risk factors related to – psychedelic-assisted therapies.
A more difficult issue revolves around the standardization of the psychotherapeutic component of MDMA-AT. While some argue that standardized psychotherapy is essential to ensure consistent and safe treatment across different settings, others propose getting rid of psychotherapy altogether, while a third group suggests that common factors – like therapeutic alliance – are the defining feature, and that the specific form of psychotherapy is less important.
What we can be sure of, is that as the demand for MDMA-AT grows, there will be an increasing need for well-trained therapists who can deliver this therapy responsibly. The establishment of clear guidelines and protocols is imperative to mitigate risks and protect patient safety.
The Impact of the FDA’s Decision on the Legal Landscape & Future Research on MDMA-aT
The FDA’s likely requirement for a third phase-3 trial presents a serious hurdle to the timely approval of MDMA-AT. The time and costs involved in conducting such a study are substantial, and will require additional fundraising. It is likely that this will postpone the availability of MDMA-AT in the USA by years. This delay is particularly concerning given the urgent need for effective treatments for PTSD, a condition that affects millions of people worldwide.
The implications for Europe are uncertain. It remains unclear whether the results of a future phase-3 trial in the USA will be leveraged to apply for marketing authorisation from the European Medicines Agency (EMA) as well. Theoretically, another phase 3 trial could also partially take place in Europe (there are trained and experienced MDMA-AT therapists sites in multiple European countries), thereby overcoming the EMA’s wish to have studies conducted in Europe. If Europe is not included, and the EMA does require additional data, this will further delay the availability of MDMA-AT in Europe, leaving many patients without access to this potentially life-changing treatment.
A Pragmatic Approach: Naturalistic Studies and Early Access
In light of these challenges, we propose a pragmatic approach that balances the need for rigorous science with the urgent need for patient access to MDMA-AT. Specifically, we support the recommendation of the Dutch State Committee on MDMA to initiate a naturalistic study in which patients are given MDMA-AT by qualified therapists in specialized treatment settings.
Such a study would provide valuable data on the real-world effects and risks associated with MDMA-AT, while also offering patients access to a therapy that they might otherwise seek in the so-called ‘underground’ or ‘grey’ circuit. A naturalistic study has the dual benefit of providing potential relief to suffering patients while advancing our understanding of the roll out of MDMA-AT in a controlled and ethical manner.
Furthermore, implementing this approach in the Netherlands could position the country as a leader in psychedelic science and innovative mental healthcare. It would enable us to gather valuable real world data, understand the complexities of offering such a therapeutic innovation in the real world, and, importantly, ensure that an increasing number of qualified therapists can gain experience conducting MDMA-AT, putting in place structures, protocols, and guidelines to enable a smooth rollout when MDMA-AT eventually becomes a mainstream therapy.
Conclusion: Balancing Rigor with Compassion In Psychedelic Science
In sum, the OPEN Foundation believes that the FDA’s decision overlooks the immediate needs of patients who stand to benefit from MDMA-AT. We recognize the importance of rigorous science in establishing the safety and efficacy of this therapy, but we also advocate a pragmatic approach that allows for early access through naturalistic studies. Only by adopting this dual strategy can we ensure that MDMA-AT is administered safely and responsibly, while also collecting the data necessary to satisfy regulatory requirements. Ultimately, the goal of such an approach would be to minimize harm, maximize patient benefit, and pave the way for MDMA-AT to become a valuable tool in the treatment of PTSD.
We call on regulatory agencies, researchers, and clinicians to work together in the spirit of collaboration and innovation, to bring this promising therapy to those who need it most.
In a landmark moment for drug policy, the Dutch State Commission on MDMA has released its highly anticipated report, “Beyond Ecstasy“. Spanning over 200 pages, this document explores the multifaceted dimensions of MDMA, including its recreational use, potential therapeutic benefits, and broader implications for public health and policy. We aim to provide you with the key highlights of this thorough examination aimed at guiding the Dutch government in its future decisions regarding MDMA.
Context of the Dutch State Commission on mdma
The formation of the State Commission on MDMA was a response to a coalition government promise to re-evaluate the drug’s status within the Dutch Opium Act. The commission, which included experts from various fields such as addiction psychiatry, criminology, emergency medicine, and drug prevention, worked from April 2023 to May 2024. This multidisciplinary approach ensured a holistic understanding of MDMA’s impact.
report presentation by wim van den brink, md, phd
Wim van den Brink, professor of Addiction Psychiatry at the Amsterdam University Medical Centers presented the report 2 days after its release at the ICPR conference in Haarlem, June 2024.
A central aspect of the report is its exploration of MDMA’s potential therapeutic benefits, particularly in the treatment of PTSD. The commission reviewed existing research and concluded that MDMA-assisted therapy shows promise for patients with treatment-resistant PTSD.
efficacy and Safety in Treating PTSD
The report discussed current research and clinical trials, highlighting the effectiveness of MDMA-assisted therapy in treating PTSD. To ensure safety and efficacy of MDMA-assisted therapy, the report highlights the importance of context.
“MDMA-assisted therapy has shown significant promise in the treatment of PTSD, particularly for patients who have not responded to traditional therapies. This could represent a major advancement in psychiatric treatment” — MDMA /// Beyond Ecstasy Report
“The therapeutic use of MDMA must be conducted under strict medical supervision to ensure safety and efficacy.” — MDMA /// Beyond Ecstasy Report
Need for Further Research: state commission Proposing a Naturalistic Study in the Netherlands
“Further research is needed to explore the long-term effects and potential applications of MDMA in various psychiatric and neurological conditions.” — MDMA /// Beyond Ecstasy Report
To facilitate the use of MDMA in therapy to treat PTSD, the commission proposes a large naturalistic study in the Netherlands. This study would help gather more data and refine treatment protocols. Wim van den Brink highlighted, “A large naturalistic study will provide the necessary data to support the safe and effective use of MDMA in clinical settings”
education and training to meet the need
“Investing in training programs and specialized centers is essential for the successful implementation of MDMA-assisted therapy.” — MDMA /// Beyond Ecstasy Report
Establishing specialized centers and training therapists are critical steps for implementing MDMA-assisted therapy. While some qualified therapists are already available, more are needed to meet the potential demand.
Prevalence and Risks of Recreational MDMA Use
“The prevalence of MDMA use in the Netherlands is among the highest in the world, yet the number of MDMA-related deaths remains relatively low, highlighting a unique consumption pattern and harm reduction practices in place” — MDMA /// Beyond Ecstasy Report
The second central theme of the report is the prevalence and associated risks of recreational MDMA use in the Netherlands. Despite the high prevalence, the report highlights that the frequency of use and the number of pills consumed per session are relatively low compared to other countries. This pattern may contribute to the lower number of MDMA-related deaths observed in the Netherlands.
The Dutch approach to drug policy heavily emphasizes harm reduction, which is reflected in the safety measures implemented at events where MDMA use is common. As noted in Wim van den Brink’s presentation at ICPR 2024, who emphasized the importance of “set and setting” in minimizing harm during MDMA use, factors such as the availability of care facilities, water, and first aid services at events significantly reduce the risks associated with MDMA use.
The report calls for improved postmortem evaluations to better understand the exact causes of MDMA-related risks. Currently, the lack of comprehensive postmortem studies makes it difficult to determine the precise role of MDMA in fatalities, especially when other substances or external factors might be involved.
Public Health and Drug Policy
The report emphasizes a public health-focused approach to drug policy, advocating harm reduction overcriminalization. It criticizes the current lack of a cohesive national drug policy and calls for an integrated prevention program. The importance of targeted drug education and continuous monitoring of drug trends is also highlighted.
“The Dutch drug policy should remain primarily aimed at public health, avoiding the criminalization of users. Prevention strategies must be evidence-based, focusing on harm reduction rather than punitive measures.” — MDMA /// Beyond Ecstasy Report
to conclude
The Dutch State Commission on MDMA’s report “Beyond Ecstasy” is a pivotal document that could shape the future of drug policy and medical treatment in the Netherlands. By addressing the risks and potential benefits of MDMA and MDMA-assisted therapy, the report aims to provide a framework for policymakers.
As the Dutch government considers these recommendations, patients in need, therapists, researchers and the general public will be paying attention. At OPEN Foundation, we are hopeful that this may be a step toward responsible, safe, and beneficial integration of psychedelics into society and healthcare.
This report (only available in Dutch) describes the current state of (es)ketamine treatments within mental healthcare in the Netherlands. The report aims to contribute to an effective and safe implementation of ketamine in the Dutch mental healthcare system. The first chapter discusses the history of ketamine, its mode of action, administration forms, and its use in mental healthcare. The second chapter discusses ketamine in the Dutch healthcare system. The third chapter focuses on ketamine as an antidepressant. Chapter four discusses the risks associated with its implementation. The last chapter addresses unresolved issues and steps that can be taken in the future. In addition to studying relevant information from previous studies and reports, information was also obtained from a large number of Dutch professionals and experts in the field. Six psychiatrists, five therapists, and three scientific researchers contributed their perspectives on current ketamine treatments, identified existing challenges, and shared their visions for the future of ketamine treatment in the Netherlands. The unanswered questions are included in chapter five and serve as a starting point for further collaborations and study of outstanding issues. The report aims to provide a clear overview of registration, implementation, unresolved issues, and guidance so that the implementation of ketamine as a treatment for TRD can be realized efficiently and safely.
Right after new results from his research on alcohol addiction and psychedelics emerged, Michael Bogenschutz confirmed his attendance at ICPR. A professor of Psychiatry at NYU Grossman School of Medicine and Director of the NYU Langone Center for Psychedelic Medicine, Dr. Bogenschutz is well known for launching the first contemporary study of psilocybin-assisted psychotherapy for alcohol use disorder in 2015. He has published extensively on the topic of addiction and the therapeutic potential of psychedelics.
Just one week ago, he reached another milestone in psychedelic research through his publication of the first double-blind randomized clinical trial of psilocybin for alcohol use disorder. This trial took a long time to complete, as the recruitment process took place from 2014 until 2020. But the wait seems worth it, as the final sample reached a total of 95 participants.
For Dr. Bogenschutz, this means a giant leap from his initial pilot study from 2015, which consisted of a sample of only 10 individuals – an issue that often looms over contemporary psychedelic research.
The study
All the individuals who participated in the study struggled with excessive drinking. More specifically, those randomized to the psilocybin or placebo (diphenhydramine) group, respectively drank an average of 7.5 and 6.6 drinks per day. Both groups received 12 weeks of manualized psychotherapy and were administered either psilocybin or diphenhydramine at week 4 and week 8.
The study wanted to assess, most of all, whether the percentage of heavy drinking days was reduced following psilocybin. They found that the psilocybin group was associated with “robust decreases in percentage of heavy drinking days over and above those produced by active placebo and psychotherapy.”
The researchers assessed this 32 weeks after their first dosing session. The percentage of heavy drinking days was still 23,6% for the placebo group, meaning they drank heavily about once every four days, but for the psilocybin group, it was only 9.7% – once every ten days.
On top of that, there were also higher reports of individuals in the psilocybin group who had stopped drinking entirely. 24,4% of the placebo group did so, compared to 47.9% of the psilocybin group.
Future research
Through these results, Dr. Bogenschutz is genuinely changing the field of psychiatry, as there have been no new drug approvals in nearly twenty years for alcohol addiction. The only three approved conventional drugs for the treatment of alcohol use disorder are currently disulfiram, naltrexone, and acamprosate. Psilocybin, as such, might become a lifesaver for many people suffering from alcohol addiction.
But Dr. Bogenschutz is not done yet, as he recently announced that there will be a subsequent trial that aims to include more than 200 participants. This time the study will consist of only one single dose of psilocybin and will be compared to the vitamin niacin as another active placebo. The Food and Drug Administration has recently approved this trial. It will be the largest to date to examine the efficacy of psilocybin-assisted therapy for the treatment of alcohol use disorder.
In recent years, there has been an uptick in attention surrounding the substance known as 5-Meo-DMT. It is popularly known as a toad’s psychedelic gift – but is now also being scientifically studied in clinical research. The compound seems ideal as a fast-acting tool for ego-dissolution, with potential therapeutic use. The substance produces stunning effects that no other psychedelic seems to match, and does so within a manageable time frame.
And oh yes: it also happens to be legally available in many locales.
This is why 5-MeO-DMT might be one of the most fascinating – and potentially useful – psychedelics there is. Just like its first cousin DMT, 5-MeO-DMT is a naturally occurring compound. It can be found in both fauna and flora, like seeds, bark, and leaves from a number of plants in the Amazonian rainforest. The Sonoran Desert Toad, official name Incilius alvarius, is its most well-known carrier and has parotid glands that provide the toad’s primary defense system: a poison potent enough to kill a grown dog. This milky secretion also happens to contain 5-MeO-DMT, or 5-Methoxy-N,N-DiMethylTryptamine. If it is collected, dried, and smoked, the toxin produces a powerful, 15-20 minute psychedelic experience that completely differs in its effects from all the other classic psychedelic compounds – including DMT, its closest molecular cousin.
The fact that it hasn’t been scheduled in many countries facilitates research into the substance. Scientists and therapists wanting to work with substances like LSD and psilocybin, which have been put on international drug control lists, need to jump through many hoops in order to get research started.
‘Fast-acting therapeutic relief’
Maybe that’s part of the reason why scientific research into the useability of this substance has now taken off. In 2019, Maastricht University investigated the effects of 5-MeO-DMT. They found that in a naturalistic setting, a single inhalation resulted in enhanced satisfaction with life and decreased psychopathological symptoms, including depression, anxiety, and stress – all of which were sustained for up to 4 weeks after the experience. ¹
This year (2022), the group, led by Johannes Reckweg, published a review of the current knowledge of 5-MeO-DMT and hypothesized mechanisms underlying its effects. It mapped the workings of the drug, and weighed its potential utility for mental health. It concluded that ongoing research was justified: “The current therapeutic potential of 5-MeO-DMT is mainly hypothetical and based on preliminary evidence. […] Although limited, the studies offer converging evidence of the potential ability of 5-MeO-DMT to provide fast-acting, and potentially immediate, therapeutic relief for depression, anxiety, and stress-related disorders (such as PTSD) in particular.” ²
When a psychedelic molecule finds its way into the 5HT2A receptor binding site, depending on its shape and charge distribution (and thus the interactions formed within the binding site), it will distort the receptor and shift it into a distinct active conformation (ON state). pic.twitter.com/d4t2KQg9yD
Dr. Chris Timmermann has also been investigating the effects of 5-MeO-DMT at the Center for Psychedelic Research, at Imperial College London. He described the gripping psychedelic for us: “What makes 5-MeO-DMT truly unique,” Timmermann says, “is its apparent ability to induce states of ego dissolution in such a reliable fashion. The structure of the experience is fundamentally altered compared to other psychedelics – which usually provide a very rich visual experience. With ‘5-MeO’, users apparently experience a ‘white light’ that is closely associated with the ego-death experience. It is that ego-death experience that appears to have a radical impact on the user, especially in the case of addiction.”
According to Dr. Timmerman, the reliability with which 5-MeO-DMT appears to induce ego dissolution and non-dual consciousness is as interesting for consciousness research as it is for experimental psychiatry. Indeed, 5-MeO-DMT appears to induce a state of “non-dual consciousness,” which refers to a state of being in which subject and object are undifferentiated, similar to that reported by experienced meditators.
Cultural origins
Unlike Ayahuasca, which has a clear indigenous lineage found in the shamanic traditions of amazonian tribes, the cultural heritage of 5-MeO-DMT remains unclear. Although numerous ceramic frog motifs found in the Santarem Territory of the Amazon suggest an indigenous connection to the animal, and some local names could allude to an elevated status of the toad, the evidence is often too ambiguous to make any direct connection to the psychedelic properties of Incilius Alvarius. Maybe future anthropological findings will shine more light into cultures that might have used it in the past. For now, its culture is a more modern tale.
5-MeO-DMT was first synthesized in 1936 by chemists Toshio Hoshino and Kenya Shimodaira but lay dormant as far as use went. Until 1983, when the book Bufo Alvarius: the psychedelic toad of the Sonoran Desert was published by a writer calling himself Albert Most. This latin name was used for the toad until its new classification as Incilius in 2006.
“Bufo Alvarius” is a seminal work describing the toad, its milky defense system and possible 5-MeO-DMT harvesting methods. The book opened the door to the modern culture of smoking the ‘toad venom’, as some tabloids called it and which -by the way- is an inaccurate term. In biology, ‘venom’ would mean the substance is injected by the toad, but it is not: it is sprayed.
That’s not the only confusion around the psychedelic toad. The taxonomy of the toad itself has changed. In 2006, it was classified as a member of the Incilius genus, so the book’s name is now dated. Also, the person laying the foundation for this new culture of toad toxin smoking, ‘Albert Most’, remained an enigma for many years.
The person behind the pseudonym was unknown for three decades, until he was revealed by psychonaut-journalist Hamilton Morris to be a man called Alfred Savinelli – who then was revealed to be an impostor by that same Hamilton Morris! In the third season premiere of his VICE Series Hamilton’s Pharmacopeia, Morris uncovers the lie of Savinelli, and exposes the real author of ‘Bufo Alvarius’ : Ken Nelson.
Nelson turns out to be a reclusive psychedelic researcher, environmentalist and veteran from Texas. To right past wrongs, Nelson and Morris released a new version of Nelson’s pamphlet, featuring Morris’ synthesis of 5-MeO-DMT.
Mainstreaming
There is still plenty of runway for the substance to create a culture of its own. It was readily available online as a ‘research chemical’ in the United States, and enjoyed limited attention. But its scheduling in the USA in 2011 provided a bolt of attention that increased its popularity. In 2019, the substance was potent enough to knock out former heavyweight boxing champion Mike Tyson, who openly talked about the spiritual awakening that resulted from his use of 5-MeO-DMT.
Soon after, others followed. Media outlets such as Forbes and the New-York Times featured stories about the transformative effects of the substance and included testimonials from ex-Navy SEAL Marcus Capone and his ongoing battle to help other Special Operations veterans access 5-MeO-DMT. All this media attention contributed to the mainstreaming of this compound in the last few years, despite its illegality.
These restrictions have hampered research into 5-MeO-DMT in the countries where it has been forbidden. But in countries like the Netherlands, multiple studies into 5-MeO-DMT are now underway.
ECOLOGICAL DAMAGE
As said, there is no indigenous ritual surrounding the use of 5-MeO-DMT, yet treatment centers using the toad’s poison have started to spring up incorporating rituals from other psychedelic cultures. These psychedelic sessions can set you back from $250 up to $8500.
This new popularity has not been good for the Sonoran Desert Toad itself, a risk voiced by Robert Anthony Villa, president of the Tucson herpetological society. Although the toad seems comfortable in human-made constructions like irrigation ditches, suburban yards and near water tanks on ranches – it is now often poached for psychedelic purposes, after which it is stressed out to produce its venom.
A solution for this animal cruelty could be a synthetic variant of the drug which would be preferable over one involving stressing out animals. That’s one of the reasons why Hamilton Morris included the synthesis process for 5-MeO-DMT in one of his episodes. The new edition of Bufo Alvarius: the psychedelic toad of the Sonoran Desert, also features Hamilton Morris’ synthesis of 5-MeO-DMT in a Mexican lab.
THE USER EXPERIENCE
When vaporized, a single deep inhalation of 5-MeO-DMT produces strong psychoactive effects within 15 seconds. After inhalation, the user usually experiences a warm sensation, euphoria, and strong visual and auditory hallucinations, due to 5-MeO-DMT’s high affinity for the 5-HT2A serotonin receptor subtype. The duration of these effects are comparable to those of DMT, lasting between 15 and 20 minutes. According to trip reports, at commonly-used doses, 5-MeO-DMT may possess the most complex and overwhelming effects of the classic psychedelic family.
Physical effects can include changes in perceived gravity, pupil dilation, muscle spasms, temperature regulation suppression, and feelings of loss of breath, but also an overwhelming intensity of physical and tactile sensations that can lead to the sensation of repeated, full-body orgasms.
Cognitive effects include distortion of space and time, amnesia, ego dissolution and auditory verbal hallucinations. Visual effects can include visual acuity enhancement, with drifting, color-shifting and morphing of complex geometrical patterns, but more often, reports mention visual suppression, where a blinding white light replaces all the visual complexity usually associated with hallucinogens. Much of this is often preceded by nausea, according to Drug Science UK.
An anonymous OPEN member described his 5-MeO-DMT experience for us as follows: “If LSD is a rollercoaster, 5-MeO-DMT is an intergalactic faster-than-light rocket that takes you to a wholly unrecognizable state of being. Landing back from a high-dose experience you are left with more questions than you came in with, but what an amazing ride it is.”
The combination of all these effects often results in transpersonal effects, during which the sense of identity of the individuals experiencing them extends beyond the personal level to humankind, nature and even the cosmos, which makes for the mystical quality of the experience. As mentioned earlier, 5-MeO-DMT also reliably induces ego dissolution, a phenomenon characterized by a complete change in normal, everyday, self-referential awareness.
CLINICAL TRIALS
So far, very little clinical research has been done on 5-MeO-DMT. The limited number of published studies suggest the compound might be safe and useful in a clinical context. If it turns out that 5-MeO-DMT does indeed have beneficial therapeutic effects, as anecdotal and early scientific evidence suggests, the promising aspects in terms of its practical use in a clinical context would be the duration of its effects.
The Beckley foundation has recently mentioned that MDMA or psilocybin-assisted therapy usually take up an entire working day for the therapist, which “poses a potential bottleneck to patient access in the future,” so a short-acting psychedelic like 5-MeO-DMT would help with both the clinical trial process and subsequent access to psychedelic therapy. As Michael Pollan mentioned in 2018: “a psychedelic therapist wants to be home for dinner too.”
Indeed, 15-20 minutes of medical and psychological supervision is a lot more manageable for clinical trials and therapists compared to the 3-6 hours that are necessary for psilocybin, or the 6-12 hours necessary for LSD. And this could eventually help in making the mystical experience more accessible.
LESS IS MORE?
The properties of 5-MeO-DMT lead to fascinating questions about its future potential utility in psychedelic-assisted therapy. But is the psychedelic indeed capable of the same types of transformations that have resulted from LSD, psilocybin and MDMA-assisted therapy? In other words: does the short-acting nature of 5-MeO-DMT come at the cost of its therapeutic benefit?
The answer to those questions is unclear as of yet. The potency of its effects suggests that the short-acting nature of the experience does not impede on its quality, but ongoing clinical trials could shed more light on them.
In many ways, ongoing research on 5-MeO-DMT will give us a window into the feasibility of short-acting psychedelic-assisted therapy, and might very well determine the fate of the emerging short-acting psychedelic field. ㅤ
There are many documentaries about psychedelics nowadays, but only so little time to watch them all, let alone figure out which one’s are worth it! That’s why we came up with a list of documentaries on psychedelics that you can watch, or binge, comfortably from your own living room. They’re selected for their scientific soundness, cultural insight, or overall high quality.
All of them are worthy study material before you join us at ICPR 2024 near Amsterdam – where some of the speakers are actually some of the people featured in these series and films. Their work is at the basis of this renaissance in psychedelic research and the new generation of documentaries that it has spawned. Enjoy our dose of inspiration.
Hamilton’s PharmaCopeiaㅤ
If there is one documentary that hits all the marks when it comes to information about psychedelics, as well as other psychoactive drugs, while simultaneously delivering a high entertainment value, it is – without a doubt – Hamilton’s Pharmacopeia, of which there are now three seasons.
This documentary series is written, directed, and produced by Hamilton Morris, a journalist and scientific researcher who explores the history, chemistry, and social impact of various psychoactive substances across the globe.
Hamilton illustrates how ubiquitous psychedelic drugs are and goes out on a limb to try several of them himself – showcasing his dedication and genuine curiosity when it comes to studying the effects of these extraordinary substances. It is beyond the scope of this article to discuss the merits of every episode on its own, but we compiled a hit list of our favorite episodes shown at the end of this commentary. That’s right – more stuff to binge this coming summer! Just watching these will suffice for at least 8 hours of entertainment, where Hamilton Morris meets with underground chemists that illegally synthesized MDMA; travels to Huautla de Jimenez in Mexico to visit the family of the legendary curandera María Sabina’s to talk about psilocybin-containing mushrooms; smokes 5-MeO DMT in the Sonoran desert under supervision of a shaman; and talks with Amanda Feilding about how she helped to fund the very first neuro-imaging study of LSD. Be sure to absolutely check this series out!
Quote of the series
“It is so strange that these compounds exist. What is the purpose of any of this? 5-MeO-DMT? This? In a toad’s venom? And people may have only started using it 30 years ago? And it produces this peak experience of love? I can’t believe it! It is so amazing!” – Hamilton Morris
Our hitlist for best episodes:
Season 1
Episode 4 – Magic Mushrooms in Mexico
Episode 6 – The Lazy Lizard School of Hedonism
Season 2
Episode 1 – The Psychedelic Toad
Episode 2 – Peyote: The Divine Messenger
Episode 4 – Wizards of DMT
Episode 5 – Ketamine: Realms and Realities
Episode 6 – A Clandestine Chemist’s Tale
Season 3
Episode 1 – Synthetic Toad Venom Machine
Episode 4 – Synthetic Ibogaine: Natural Tramadol
Episode 6 – UItra LSD
Descending the mountain (2021)
Filled with aesthetically pleasing images, jaw dropping cinematography, a great psychedelic soundtrack, and a pinch of neuroscience, Descending the Mountain excels at every front. The documentary includes renowned psychedelic researcher Prof. Dr. Franz Vollenweider and Zen master Vanja Palmers. Their mission? To set out to a monastery on top of mountain Rigi in Switzerland to conduct a novel experiment in which experienced meditators received psilocybin-containing mushrooms in a group setting for the first time in their life. This experiment was double-blind, where neither the researchers or the participants knew what dose they received. Some of the meditators received an active dose of psilocybin, whereas others were ‘unfortunate’ (in their words) and received a placebo. It is amazing, to say the least, how these experienced meditators were able to deepen their meditation due to psilocybin, even after thousands of hours of meditation practice. One individual was completely ecstatic from the beginning till the end and amazed by what he was experiencing. Others felt it to be a collective experience, rather than an individual one, as they were able to feel the energy in the room. Ultimately, placebo or no placebo, the group setting was conducive to the experience at the mountain.
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“What can the mushrooms tell us today?” – Descending the Mountain
Halfway through the documentary, Prof. Dr. Vollenweider explains briefly how psychedelics work and that neuroscientific research of today has consistently demonstrated that they deactivate the Default Mode Network (DMN) – a key brain region involved in self-referential processing. With their experiment on Mount Rigi, they too found that the participants who received psilocybin were able to enter a deep(er) meditative state and showed less activity in the DMN when compared to the placebo group. Vollenweider explains how it: “makes you less focused on yourself because, in a way, you lose your ‘self’, and that this tends to make you focus more on others around you.” This dovetails neatly with the hypothesis that psychedelics are able to alter personality and political beliefs, something that the documentary explores briefly as well through asking significant questions as: “What can psychedelics do for society today? What will happen if great leaders take these substances and make us think about our place in the world?”
Michael Pollan’s How To Change Your Mind (2022)
Four years after the release of his book under the same name, Michael Pollan hit the big screen on Netflix with a documentary series: How to Change Your Mind. To say that his book had somewhat of an influence on the psychedelic renaissance is an understatement. Individuals even talk about a Pre-Pollan era and Post-Pollan era within psychedelic research. And now, with this new and cinematic tour du force, Pollan might continue to increase his reach by showcasing these tools to people all over the world sitting in their living room.
The documentary consists of a total of four episodes, each focusing on a specific psychedelic. The first episode focuses on the synthesis of LSD by Dr. Albert Hofmann in 1938, the research of its therapeutic use when treating alcoholism, and how it ultimately became a Schedule I substance – as it ended up on the streets through evangelist Timothy Leary and the CIA project MKUltra, that serendipitously turned on Ken Kesey. In the second episode, the viewer is brought to the world of psilocybin-containing mushrooms and features ICPR speakers William Richards, Paul Stamets, and Roland Griffiths. Here, Pollan discusses their historic use in religious settings, the introduction of the mushroom to the West, and how it is currently being researched for various debilitating psychiatric disorders, such as depression, end-of-life anxiety, obsessive compulsive disorder, and cluster headaches. The third episode features ICPR speaker Rick Doblin and is all about the therapeutic use of MDMA for the treatment of post-traumatic stress disorder. Pollan interviews Ann Shulgin, the wife of renowned chemist Alexander Shulgin, – who recently passed away – about her personal experiences with MDMA and how it ended up becoming illegal through the so-called “Second Summer of Love”’ during the 1980s. Finally, Pollan takes a deep dive into the ceremonial use of the peyote cactus by indigineous Americans that are part of the Native American Church.
The documentary provides a solid starting point for anyone who is new to the world of psychedelics and likes to be prepared for what we have to offer at ICPR. It presents some of the most recently conducted preliminary research studies and their implications. Contrary to contemporary media headlines, it is refreshing to see that Pollan remains centered throughout the entire documentary with regards to the therapeutic potential of psychedelics and messages to the audience to do the same. This is a welcoming message that is to be embraced if we do not wish to repeat past mistakes.
The Psychedelic Drug Trial (2021)
Major depressive disorder (MDD) is the leading cause of disability in the West, says ICPR speaker and Professor of Neuropsychopharmacology David Nutt. Across the globe, MDD is estimated to affect 350 million individuals and is responsible for more ‘years lost’ than any other psychiatric condition. Psychiatry has been desperate for novel treatments.
One of the current mainstays of treatment in psychiatry is escitalopram, a selective serotonin reuptake inhibitor (SSRI), better known under its brand name Lexapro. This psychotropic drug increases the amount of the neurotransmitter serotonin in the brain and has been proven by earlier clinical research to be effective and well tolerated in the treatment of MDD. But this begs the question: “How does escitalopram, or Lexapro, compare to psilocybin when used for treating depression?” This is what the research team in the Psychedelic Drug Trial set out to do.
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“If psychedelics can change the world, let’s put it to the test.” – Dr. Robin Carhart-Harris
The documentary presents an extensive in-depth look into how the study was conducted by displaying easy-to-comprehend visuals and various infographics. The documentary really shines here and you immediately get a clear understanding of what the study design looked like. It also exemplifies how current psychedelic therapy operates and provides the three important stages involved, which includes: preparation before the dosing session, the psychedelic dosing session itself, and the integration that follows.
What is more, you get to know some of the recruited participants who were told that they are randomized to one of two conditions. They will either receive 1) psilocybin or 2) escitalopram, not both. Almost all of the participants have been on antidepressants for decades and suffer from various side effects, including weight gain, sleep paralysis, and a flat affect. The psilocybin trial represents a “lifeline” according to some of the participants – a viable alternative to their current situation of “concentrating on staying alive” and trying “to live with this joylessness.” One participant is at the end of her ropes and tells the camera: “I would probably end my life if I didn’t go [through the trial].”
Soon after this introduction, we are taken into a living room like environment where the psychedelic therapy session took place. Participants at this point are talking about their extraordinary experiences and the various symbols they encountered during their psychedelic dosing session. The documentary really excels here due to its slow presentation of recorded monologues and by displaying aesthetic visuals that are aimed at encapsulating the participants’ experience while on psilocybin. One participant talks about one of her peak experiences where she found herself at the roots of a tree and: “was connecting with everything up there. The thing I really felt most … was a joy. Joy like I’d never experienced. It is really, really powerful stuff.”
The documentary would not have been complete without a brief presentation by ICPR speaker David Nutt on how psychedelics such as psilocybin work in the brain and how they differ from escitalopram. Nutt first explains that antidepressants as escitalopram take about an average of six weeks to work and do so primarily in the limbic system, the emotional center of the brain that is overactive in depression: “It dampens the system and you become incubated against stress, which is good, but you also become incubated by everything else.” Psilocybin, on the other hand, works differently by targeting the serotonin 2A receptor, which are widely prevalent in the neocortex. Psilocybin also works through the disruption of the Default Mode Network that Franz Vollenweider similarly talked about in Descending the Mountain. Both professor Nutt and lead researcher of the study Dr. Robin Carhart-Harris believe that psilocybin works better and faster than escitalopram.
The results of this landmark study have been published in the highly esteemed The New England Journal of Medicine. Their conclusion? Both psilocybin and escitalopram work in the treatment of depression. But when taking into account secondary outcome measurements such as suicidality, psilocybin looks better than escitalopram. More recent neuroscientific findings of the current study have been published as well, which looked at how psilocybin affects the brain and how it differs from antidepressants. All in all, more research is needed as we venture forth in our pursuit to help people alleviate their depressive symptoms.
Journeys to the Edge of Consciousness (2019)
Journeys to the Edge of Consciousness is a unique animated film that chronicles the very first psychedelic experiences of Timothy Leary, Aldous Huxley, and Alan Watts. The film is interspersed with commentaries on these historical and influential events by ICPR speakers Rick Doblin and Amanda Feilding, and various other researchers within the psychedelic field.
The Dropout Drug
We first witness how Timothy Leary got involved with LSD through meeting Michael Hollingshead, a British researcher who studied psychedelics at Harvard University in the mid twentieth century. Leary’s first LSD trip was: “the most extraordinary experience of his life.” Yet to my surprise, he also felt a terrible sense of loss after this trip, as he did not know what to do with these new insights: “Once you see how it is all composed, it is hard to get back to the game.” This experience demonstrates that even psychedelic evangelists as Leary, a very intelligent man who was probably one of the most well-known proponents of psychedelics, would have benefitted from the importance of integration. The world would have been a very different place indeed if Leary underwent this integral part following psychedelic use. Instead, he decided to leave the highly esteemed university of Harvard and famously told students to: “tune in, turn off, and drop out.” This resulted in the then U.S. president Richard Nixon to call him the most dangerous man of America.
Commentaries from other experts on Leary’s psychedelic experience are very informative. They exemplify how psychedelics are able to lift the veil of ordinary reality, which can either facilitate, or in the case of Leary, diminish our well-being, because we see through the illusion, i.e., the play of life. You’re catapulted out of your ego and you can spend years of life making sense of it all, which might have happened to Timothy Leary according to Dr. Tim Read. Yet, Dr .Gabor Maté states that bad trips can also be interpreted differently: “Yes, a trip can be challenging, but what you need is proper integration. This is the work of healing. The psychedelic experience and its healing properties were lost during the 60s because there was a lack of intention.
The Doors of Perception
Next we get a close look at Aldous Huxley’s famous psychedelic experience with mescaline that led him to write his famous work The Doors of Perception: and Heaven and Hell. During his experience, he realizes that “this is how one ought to see” and that the ordinary mode of consciousness is but one form of consciousness. Huxley talks about the suchness of things while on mescaline and develops his metaphor of the reducing valve of the mind, which limits our view of reality and who we really are.
According to ICPR speaker Rick Doblin, Huxley’s insights demonstrate where we should put our meaning: “not on consuming, but on something deeper.” Other psychedelic researchers talk about how people ‘wake up’ after their psychedelic experience, including alterations of the perception of the self and various changes in their value system.
The Joyous Cosmology
Finally, we witness Alan Watts taking modest amounts of LSD while in California and who decided to casually go for a stroll. His first undertaking was to listen to a priest in a church during a mass. He witnesses how people are putting on an “act of a person”, which is one of the key phrases of Alan Watts. His feeling of self became no longer confined to the insides of his skin as he felt connected to everything: “my individual of being seems to grow out to the rest of the universe.” The animated re-enactment of Alan Watts’ psychedelic experience gives us a glimpse into how psychedelics helped shape his philosophy.
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“Come off it shiva, you rascal, who do you think you’re kidding!? It’s a great act, but you’re not fooling me!” – Alan Watts
Neurons to Nirvana (2013)
Neurons to Nirvana is filled with numerous psychedelic researchers who will be attending ICPR, including Rick Doblin, William Richards, David Nutt, Roland Griffiths, and Amanda Feilding. The film gives a brief overview of classic psychedelics, including psilocybin, ayahuasca, and LSD. In addition, the entactogen MDMA is briefly discussed plus the medicinal benefits of other (non-)psychoactive substances as marijuana and cannabidiol.
The film starts with the serendipitous event of how psychedelics helped shape modern psychiatry and neuroscience. LSD, as it turns out, has a very similar structure to serotonin that led to the discovery of the serotonin neurotransmitter system. As a result, psychiatry started including brain chemistry into the disease process, whereas before all the accountability went to either the individual or the environment.
It was a revolutionary period for which the famous psychedelic researcher Ralph Metzner said that discovering psychedelics: “was like discovering another continent, like Marco Polo.” Both ICPR speakers Rick Doblin and David Nichols mention how psychedelics are able to occasion a mystical experience and how this helps experience the world as one as it breaks down certain barriers. Roland Griffiths adds: “there is this quantum change during a psychedelic experience – it belongs among the most spiritual and personal meaningful experiences of peoples’ lives.”
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“What is being purged actually, is psychological contents that you’ve been holding onto. You’re purging anger, you’re purging pain, you’re purging some false story about the self.” –Gabor Maté M.D.
A great feature of the film that is worth mentioning here is that it shows the capability of human individuals being able to change their beliefs when it comes to esoteric substances such as psychedelic drugs. This is illustrated when Dr. Sanjay Gupta appears on the big screen, an Emmy award-winning doctor for his show on CNN who used to vehemently oppose the use of marijuana. This was until the year 2009, as the scientific evidence started accumulating and Dr. Gupta discovered that it was used for thousands of years. He also found out that before there was a strong focus on the negative. Most importantly, Dr. Sanjay Gupta was illuminated by the benefits of marijuana: “the science is there!”. This clearly demonstrates how scientific evidence can pave the way for reconstructing our beliefs about psychedelics. Hopefully, other physicians, researchers, and politicians will follow suit.
The Last Shaman (2016)
The Last Shaman follows young adult James who is battling with crippling bouts of depression ever since he went to university. He is desperate for a way out as he tried doing everything according to the book on both a medical and personal level. In general, this involved seeing several psychiatrists, taking antidepressants, and picking up a regular meditation practice. Despite his arduous efforts, he remains depressed. At the end of his ropes, he travels to Peru to meet several shamans that might be able to help him.
The documentary is not for the faint of heart and can be very shocking in demonstrating how debilitating depression can be. James suffers from extreme anhedonia, which refers to the inability to feel pleasure: “I see a beautiful woman or a sunset and I feel nothing.” He explains how his depression affects him in front of the camera and this raw footage makes the documentary feel very personal, but also heart-wrenching to watch at times, as his eyes are filled with tears and his voice is featured by a tremendous amount of frustration and despair. He ends up meeting various shamans in different regions and engages in multiple ceremonies to finally reach salvation.
James’ journey ends deep within the forest at the Shipibo community – a place that resembles just the right amount of authenticity he is looking for. Shamans here do the practice because it is a calling, whereas the business side of things are left aside. James ventures deeper into his emotions, revealing one layer from another layer, and becomes a passionate ascetic. He maintains a very strict diet and stays in isolation for a total of four months, eating nothing but fish and rice and smoking the Mapacho tobacco. This experience ripped him of all attachments of his previous life. He believes he: “no longer has an inferiority complex anymore” and feels no more anger towards his father.
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“I’m here to be a very small part of something much larger than myself, and that is extremely liberating” – James
Iboga Nights (2014)
David Graham, the director and producer of the renowned and brutal documentary Detox or Die, returns to the big screen with Iboga Nights. His first documentary consists of his mission to cure himself of his opiate addiction through ibogaine – a psychedelic substance with dissociative properties that is extracted from the root bark of the iboga tree (Tabernanthe iboga). His film became a resounding success that resulted in an explosion of media, press and news articles. This inspired other addicts to follow in his footsteps by taking up ibogaine and get rid of their opiate addiction once and for all. Iboga Nights follows several of David’s ‘apprentices’.
Iboga Nights is basically split up in three sections. The first is where we are introduced to a shaman from the Netherlands who has treated an approximate of 1,000 patients with ibogaine for their opiate addiction. To my surprise, there was almost no guidance involved; the shaman plainly administers the drug and then lets ibogaine take its course while the participants stay in their assigned bedroom. It was quite astounding to see how most turned out fine and even managed to go through the treatment without experiencing any withdrawal symptoms. However, the documentary quickly takes a dark turn that illustrates the significance of taking into account proper screening and guidance. For instance, one participant stopped breathing due to an underlying heart condition and was taken away to the hospital. Ibogaine is known for slowing down the heart rate that might be fatal. Fortunately, he survived. But another participant left the house and was hit by a truck. David wanted to end the film right there: “how can I be a spokesperson for something so dangerous?”
After these horrific events, David meets up with Dr. Ben Sessa and Dr. Jeffrey Kamlet to talk about psychedelic research and ibogaine. Both share a pessimistic view with regards to pharmaceutical companies and how they supposedly “treat” patients, as they make billions of dollars on pain pills that generally require daily use. Naturally, they scoff at this predicament: “Why do they want ibogaine that requires one dose to cure people. That does not make money?”
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“Does it not feel weird to have had that life, among such affluence, and now be living in a hotel shooting up crack and heroin and taking up methadone?” – David Graham
Fortunately, the documentary also contains the amazing journey of Sid who was severely addicted to morphine and completely transformed through his ibogaine treatment. He was sexually abused by an older man when he was only 11 years old. During his session, both David and Sid are serious by taking screening and guidance into account. For example, they check if Sid is allergic to ibogaine and during the ibogaine treatment will frequently measure his heart rate and blood pressure. It is astounding to see that even after fivedays of taking ibogaine and no morphine at all, any symptoms of withdrawal are virtually non-existent. But Sid knows that the real treatment starts after ibogaine, which requires integration and (simply) staying off the drug. Several months later David returns to visit Sid and witnesses another person in front of him. He has become a completely transformed person and has much more energy and life in his eyes. Sid talks briefly about his ibogaine experience: “I did not have many visions or anything, but it took my physical dependence away.” The urge, or craving to use drugs, is totally gone. Sid simply does not: “want to do that anymore.”
From Shock to Awe (2018)
The documentary From Shock to Awe chronicles the transformative journey of two military veterans that suffer from severe post-traumatic stress disorder (PTSD). Because of this, everything they encounter on a day-to-day basis within their natural environment signals danger. With their bodies still in war and drugged by an arsenal of pharmaceuticals, they turn to the Amazonian brew ayahuasca as a last resort.
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“I left the warrior behind and let the sunlight take the steering wheel now.”
Both veterans are filmed during their ayahuasca retreat that consisted of four ceremonies, two during the day and two at night. During all dosing sessions, we see grueling raw footage of both veterans struggling with their deep-rooted trauma. The entire retreat resembles the archetypal hero’s journey of diving into the unconscious and coming back into the real world reborn. Through ayahuasca, they realized that all life is sacred, which is: “the exact opposite of what is learned during military training.” Their perception of everyday ‘signals as danger’ changed after only one weekend, as they heard a gunshot in the woods, locked eyes, and started laughing immediately. The PTSD response was no more.
Ann Shulgin, the wife of renowned chemist genius Alexander “Sasha” Shulgin, passed away at age 91 on July 9. Both were extraordinary human beings and pioneers in the field of psychedelic research, particularly due to their significant contribution in the development and therapeutic use of (novel) psychedelic compounds. To honor both, we gladly share some of her history and both their legacy.
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Laura Ann Gotlieb was born in Wellington, New Zealand on March 22, 1931, and shortly thereafter lived an extraordinary life, spending her time in various places around the world, including Italy, Cuba, Canada, and finally the Bay Area in the US when the Beatnik generation was in full swing. She got married, and divorced, three times and then met her fourth husband, Sasha Shulgin, in the Fall of 1978. After three years of spending time together, they got married in Sasha’s backyard during a surprise ceremony by an official of the Drug Enforcement Administration. Yes, the DEA.
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Ann used to work as a medical transcriber in San Francisco and probably became familiar with Jungian psychology through her third husband who was a Jungian psychiatrist. It was only later after marrying Sasha that she got involved in the development of novel psychedelic compounds. During this period, she started practicing psychedelic-assisted therapy in conjunction with MDMA or 2C-B at a time when these substances were still legal. She became a strong adherent of Jungian psychoanalysis and believed that psychedelics have huge potential for self-actualization when used within such a framework.
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The development and various discoveries of other psychedelics together led to the authoring of two books: PIHKAL: A Chemical Love Story and TIHKAL: The Continuation. Respectively, these titles are acronyms for “Phenethylamines/Tryptamines I Have Known and Loved.” Partly fictional autobiography and partly considered “pretty much cookbooks on how to make illegal drugs” by the DEA, both Ann and Sasha were filled with passion and courage to describe no more than over 179 different psychedelic compounds – all with the main goal of releasing information about psychedelic compounds and its therapeutic properties to the public. Psychedelics, they both believed, were there as valuable tools for human beings to explore and self-actualize. Ann briefly appears on a recent episode of Hamilton’s pharmacopeia,where we see that she continued to live in the house that contains the original lab of Sasha.
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We are forever grateful for their contribution to the development and therapeutic use of (novel) psychedelic compounds and aim to continue their legacy.
“We told people that it was in the name of the Holy Spirit, the Father and the Son, but in reality it is in the name of the Sun, the Moon and the Tiger…”
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While the potential benefits of psychedelic plant medicines to society still remain largely unrealised, contemporary psychedelic studies risk replicating harmful colonial practices within the territories and communities in which the use of psychedelic plants originate.
After decades of prohibition, the so-called “psychedelic renaissance” is undertaking a state-of-the-art exploration of the psychology, neurology and medical approaches associated with the effects and benefits of psychedelics. The field runs the risk, however, of privileging the voices of mainstream western male researchers over those of the indigenous practitioners whose ancestral knowledge of psychedelics roots back to their origins (George et al, 2020).
A decolonial approach is essential to the success of the current psychedelic renaissance, as failing to recognize indigenous perspectives as equally valuable to the discussion in the appropriate use of these substances only contributes to deepening the colonial wound within which usage of the plants is interwoven. As academia reconsiders previously taboo subjects (such as mind-altering substances), it has the duty to reconsider also the re-enactment of colonial epistemicide (the killing off of existing systems of knowledge), and give indigenous expertise the space it deserves in scientific research.
The very old relationship between humanity and the ritual alteration of consciousness is, in indigenous communities, deeply linked to systems of traditional medicine. Nevertheless, in the West, practices associated with mind-altering substances have faced decades of strong political opposition and, as the renaissance unfolds, there are other, more subtle threats being held at bay, specifically the peril inherent in silencing other voices because of their culturally diverse backgrounds.
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Ayahuasca’s history and its critical entanglement with colonization:
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Ayahuasca, or yagé, is a traditional brew from the Amazon rainforest that contains the classic psychedelic compound DMT. It has a long history of use by indigenous peoples in the Amazon basin, where it is mainly used for ritual and healing purposes, usually in ceremonial settings led by a shaman or curandero.
Ayahuasca is a particularly complex substance that relies on two intersecting components to deliver its psychedelic effects. Psychotria viridis, or chacruna, is a shrub, the leaves of which contain the DMT. Banisteriopsis caapi is a vine that contains monoamine oxidase (MAO) inhibitors, which prevent MAO enzymes in the stomach from breaking down the DMT as they’d normally do, thus allowing the body to actively absorb it when it is consumed orally. Taking into account the improbability of discovering the function of this particular combination of a shrub and a vine amongst the the tens of thousands of different plant species in the Amazon, along with the preparatory process needed to coax out its psychoactive properties, ayahuasca can be considered an invention, a piece of technology developed by the Amazonian people.
The indigenous people of the Amazon relate to their surrounding environment in a way that lends itself to developing a great body of ethnobotanical knowledge. Much of the knowledge that has been produced by indigenous people has, however, been the subject of appropriation and biopiracy, as the history of the rainforest cannot be grasped separately from the history of the colonization of the Americas.
One can go back to Western explorers and botanists to trace historically how ayahuasca came to be known outside the jungle, Richard Spruce and Richard Evans Schultes, for instance, were some of the first outsiders to report on indigenous plant medicines. But, by telling and re-telling the story in such a way, a colonial version of history is reinforced where indigenous peoples and their knowledge are passively discovered by Western institutions, their own contribution, skill, and subjectivity neglected, minimized, or reduced to naturalistic fact.
The history of the Amazon has been shaped by the way that the Western European imagination has interacted with this territory: from the mythic quests to find rivers of gold in the 16th century as the Spanish conquistadors mapped the Amazon river in the search for El Dorado, to the rubber barons of the 20th century who exploited and enslaved hundreds of thousands of indigenous people as they strove to realize enormous profits. The Amazon is a territory that has been perceived as a well of treasures to be extracted and appropriated.
Today’s deforestation crisis, related to the extraction of precious timber and the clearing of trees for cattle, are an inheritance of old relationships with this land that still conceives of the Amazon as an uninhabited space full of natural wealth and resources. The rainforest has been historically included in the world’s economy only in terms of exploitation, and indigenous communities as well as their knowledge have been objectified in the same way as their land.
Ayahuasca, curiously, was used during colonial times as a way of resisting and contesting the settler invasion. As the conquistador’s culture demonized indigenous ritual and traditional medicine, ayahuasca was used as a way of exercising and preserving indigenous identity, and was perceived as a repository of cultural memory for the peoples of the Amazon (Leyva, 1991).
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Other versions of history; Ayahuasca/Yagé and its traditional users:
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To trace historically the movement of ayahuasca and other plant medicines one need not rely entirely on the Western explorers and botanists who explored the Amazon and taxonomized its species. Ayahuasca traveled outside of the Amazon via old shamanic networks that for centuries wove an exchange of knowledge and ritual technologies (Pinzón et al., 2004). For instance, the Putumayo department, located in southwest Colombia, is divided into three sub regions: The Upper Putumayo (Andes mountain range), Middle Putumayo (Amazon foothills) and Lower Putumayo (Amazon basin). The Sibundoy Valley which is famous for being home of prominent ayahuasca shamans in Colombia, is located in the Upper Putumayo, a geographical node between the Andes and the Amazon. People who inhabit the area are both settlers and indigenous people who belong to two ethnic groups, the Inga and the Kamentsá.
Relations – including shamanic ones – have existed for centuries between the Upper Putumayo (Andes) and the Lower Putumayo (Amazon). The Cofán, Siona and Coreguajes, who are known to be powerful shamans, live at lower elevations where rainforest vegetation flourishes. As ayahuasca cannot grow outside of the tropical forest, shamans from the Upper Putumayo have long traveled down to acquire the brew and, in doing so, maintained a cross-pollinating network that exchanges plants, ritual and healing technologies, and cosmological knowledge (Pinzón et al., 2004).
In their travels to the Amazon basin, Ingas from the Upper Putumayo learnt the uses and powers of shamanic plants and engaged in shamanic apprenticeships (Pinzón et al., 2004) with the help of shamans from this area. They then transported plants and other ritual devices, including ayahuasca, from the low tropical forest to Sibundoy. The memory of the botanical relationship between shamans was retained in their respective gardens, disseminating and preserving thus the interchange of knowledge between the Amazon and the Andes.
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Such movement helped inform the transformation of indigenous practices which came into contact with Catholic missionaries and the general mestizo culture of the rest of the Colombian territory. As we can read in the next excerpt from an interview with a shaman from the Sibundoy Valley:
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When I was born, the first thing they gave me was three drops of yagé (ayahuasca). We told people that it was in the name of the Holy Spirit, the Father and the Son, but in reality it is in the name of the Sun, the Moon and the Tiger. That’s how my blood began to be painted.” (Pinzón et al. 146 )
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As the previous passage shows, the ritual use of ayahuasca in this area was influenced by the dominant Catholic religion, while at the same time acting as a mechanism to contest and resist the colonial apparatus. The previous statement beautifully depicts how indigenous ritual practices were disguised using catholic motifs as a way to preserve silently their identity: Giving three drops of ayahuasca in the name of the Father, the Son and the Holy Spirit, to conceal it was really given in the name of the Sun, the Moon and the Tiger.
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“…Two years later Eliseo was back again, by bus all the way across the country to dip once more into what he saw as the Indian well of magical power” – (Taussig, 1986. p 435)
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With this sentence Michael Taussig begins chapter 27 of his book “Shamanism, Colonialism and the Wild Man” (1986) where, “The Indian well of magical power,” was, of course, the Amazon. Since the very first stages of colonization, the Amazon was a screen upon which European minds could project fantastical mirages of imaginary geographies populated by noble, primitive, and superstitious savages. The picture of an ‘Indian well of magical power’ is a reflection of this. A well of vast and mysterious treasures, gold, rubber, magic, and endless resources, where indigenous communities were perceived through a lens of intellectual inferiority. The Amazon consequently epitomizes and condenses several European fantasies surrounding a mysterious, irrational and exotic Other.
What Taussig was looking for in that ‘Indian well of magical power’ was ayahuasca shamanism, where the otherness of indigenous knowledge is capable of healing the maladies of the West. It is precisely the same phenomenon seen when the renowned writer William Burroughs went on a journey to find ayahuasca in Colombia, thinking that it might be his ‘final fix’ (Fotiou, 2019).
The same trope is seen with contemporary ayahuasca tourism, where huge numbers of people from all over the world (though predominantly European and American) travel to the Amazon in search of healing through the exotic otherness of ayahuasca (Losonczy & Mesturini, 2010) (Caicedo, 2009). The contemporary medical approaches to ayahuasca and other psychedelic plant medicines follow the same lines, wherein ayahuasca is being researched for its potential to treat some of the most pervasive illnesses of our time, such as depression, anxiety, and addiction (Fotiou 18)(Frecska et al.) (Palhano-Fontes et al.)(Richards) (Watts et al.) (Roseman et al.).
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An interdisciplinary future:
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As psychedelic plant medicines re-enter Western culture, researchers in this field must be aware of the colonial history behind these plants and the communities from which they come to avoid perpetuating the same type of intellectual violence that underlies the old notion of the “noble savage” and current practices of biopiracy. As we enter a globalized society, it will be critical to give regard to knowledge that comes from different cultural and ethnic sources, bestowing upon them equal validity in the discussion of the adequate use of these substances. Mainstream psychedelic research will need to encourage and actively include researchers from diverse ethnic backgrounds, as a diversity of voices and perspectives can only contribute to the advancement of science.
Besides giving credit to indigenous knowledge (which kept this technology alive for at least the past millennium) it is necessary to recognize the contribution of people of color, women, and researchers from Latin American in the development of psychedelic research, as well as to create spaces within which their perspectives can be heard and included.
Understanding how to use these substances will, in the end, require an interdisciplinary effort. The cutting-edge research being performed on psychedelics in the fields of neurobiology and psychology will see its most fruitful results by working hand-in-hand with the humanities (anthropology, decolonial studies, religious studies, philosophy, etc.) to avoid the pitfalls inherent in the epistemicide of non-western voices. The task at hand for the humanities is to reflect on the body-politics of knowledge, help give voice to traditional and indigenous ethno-medicine systems, and create the foundation for a renaissance free from harmful colonial appropriation and silencing.
In conclusion, ayahuasca has a lot to offer the world, as current scientific studies continue to prove its therapeutic potential. It, along with other psychedelic plant medicines, have enormous possibilities in the ongoing fight to alleviate psychological and spiritual suffering. The real question, then, is what can we give back, to the Amazon, to the people that inhabit it, to the preservation of their systems of knowledge, to their worldview and culture, to the most diverse ecosystem of the Earth?
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What can we give back?
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References:
1. Caicedo, Alhena. Nuevos chamanismos Nueva Era. 2009, p. 18. 2. Fotiou, Evgenia. ‘The Role of Indigenous Knowledges in Psychedelic Science’. Journal of Psychedelic Studies, vol. 4, no. 1, Dec. 2019, pp. 16–23. DOI.org (Crossref), doi:10.1556/2054.2019.031 3. Frecska, Ede, et al. ‘The Therapeutic Potentials of Ayahuasca: Possible Effects against Various Diseases of Civilization’. Frontiers in Pharmacology, vol. 7, Mar. 2016. DOI.org (Crossref), doi:10.3389/fphar.2016.00035 4. George, Jamilah R., et al. ‘The Psychedelic Renaissance and the Limitations of a White-Dominant Medical Framework: A Call for Indigenous and Ethnic Minority Inclusion’. Journal of Psychedelic Studies, vol. 4, no. 1, Mar. 2020, pp. 4–15. DOI.org (Crossref), doi:10.1556/2054.2019.015 5. Leiva, A., Guerrero, H., Pardo, M., JUNCOSA, J., & AMODIO, E. (1991). Los espíritus aliados: chamanismo y curación en los pueblos indios de Sudamérica. Ediciones Abya Yala, Quito, (31). p. 47 6. Losonczy, Anne-Marie, and Silvia Mesturini. ‘La Selva Viajera: Rutas del chamanismo ayahuasquero entre Europa y América’. Religião & Sociedade, vol. 30, no. 2, 2010, pp. 164–83. Crossref, doi:10.1590/S0100-85872010000200009 7. Mignolo, Walter D. ‘Epistemic Disobedience, Independent Thought and Decolonial Freedom’. Theory, Culture & Society, vol. 26, no. 7–8, Dec. 2009, pp. 159–81. DOI.org (Crossref), doi:10.1177/0263276409349275 8. Miller, M. J., Albarracin-Jordan, J., Moore, C., & Capriles, J. M. (2019). Chemical evidence for the use of multiple psychotropic plants in a 1,000-year-old ritual bundle from South America. Proceedings of the National Academy of Sciences, 116(23), 11207-11212 9. Palhano-Fontes, Fernanda, et al. ‘The Psychedelic State Induced by Ayahuasca Modulates the Activity and Connectivity of the Default Mode Network’. PLOS ONE, edited by Dewen Hu, vol. 10, no. 2, Feb. 2015, p. e0118143. DOI.org (Crossref), doi:10.1371/journal.pone.0118143 10. Pinzón, Carlos, et al. ‘El Jardín de La Ciencia En El Valle de Sibundoy’. Mundos En Red: La Cultura Popular Frente a Los Retos Del Siglo XXI, 2004, pp. 139–99 11. Richards, William A. ‘Psychedelic Psychotherapy: Insights From 25 Years of Research’. Journal of Humanistic Psychology, vol. 57, no. 4, July 2017, pp. 323–37. DOI.org (Crossref), doi:10.1177/0022167816670996 12. Roseman, Leor, et al. ‘Emotional Breakthrough and Psychedelics: Validation of the Emotional Breakthrough Inventory’. Journal of Psychopharmacology, vol. 33, no. 9, Sept. 2019, pp. 1076–87. DOI.org (Crossref), doi:10.1177/0269881119855974 13. Taussig, Michael. Shamanism, Colonialism and the Wild Man. The University of Chicago Press, 1986 14. Watts, Rosalind, et al. ‘Patients’ Accounts of Increased “Connectedness” and “Acceptance” After Psilocybin for Treatment-Resistant Depression’. Journal of Humanistic Psychology, vol. 57, no. 5, Sept. 2017, pp. 520–64. DOI.org (Crossref), doi:10.1177/0022167817709585
If you’re interested in psychedelics, then you might have heard of the work of Robin Carhart-Harris, who conducted much of the most relevant research in the world of psychedelics together with his team at Imperial College in London.
In this look back at ICPR 2016 we will highlight the talk he held about his team’s trials with psychedelics-assisted psychotherapy, where he also showed some beautiful visuals of his team’s brain research, which happened to become some of the most famous psychedelic brain imagery known on the internet.
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Like our upcoming ICPR 2022 near Amsterdam, the edition in 2016 strove to bring together as many relevant studies from psychedelics as possible, and Carhart-Harris’ talk was most certainly a highlight. His research has been cited often and his talk was one of the best-watched from that year’s ICPR on our Youtube channel.
In his talk, Carhart-Harris talks about the results of his research – that psychedelics can cause a rise in cognitive flexibility, neuroplasticity, creative thinking, imaginative suggestibility, emotional lability, positive moods, and optimism.
He also touches on the idea of depressive realism, a trend he has seen in patients suffering from depression. He describes their depression as a “sort of delusion”, where his patients “don’t see the world as it really is. There is this really quite evident pessimism bias, that is normalised post-treatment with psilocybin.”
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A testimony of one of the participants is featured in the talk:
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26:35 — ‘Although it’s early days yet, the results are amazing. I feel more confident and calm than I have in such a long time. My outlook has changed significantly too, I’m more aware that it’s pointless to get wrapped up in endless negativity. I also feel as if I’ve seen a much clearer picture. [Now] I can enjoy things the way I used to, without the cynicism, without the oppression. At its most basic. I feel like I used to before the depression.”
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Brain Scans
One way to go about investigating psychedelics is by making fMRI brain scans. These scans are made of healthy and depressed individuals before, during and after a psychedelic experience. This way, the brain can be observed for changes.
Through these scans, the team got insights into the inner workings of the brain during psychedelic trips, and how they correlate with described experiences of volunteers, like ego-death. This is a type of experience in which people who are under the influence of psychedelics describe a certain loss of self, and a deeper connection with the wider universe or nature.
Carhart’s studies have highlighted that the Default Brain Network may be connected with our sense of self – our ego – and that the lower activity of this network during a psychedelic session may be associated with the occurrence of ego-death.
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12:40 — “We see quite reliably a relationship between the magnitude of the disintegration and the default brain network. [..] The greater the disintegration of the default mode network, the greater our volunteers’ ratings of ego-dissolution. ”
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During the psychedelic experience induced with psilocybin, the parts of the brain associated with the Default Brain Network show a drastic reduction in activity, often creating the experience of ego-death. The compulsive activity of the Default Brain Network also has been associated with patients that scored higher in depression ratings.
The Default Brain Network and the Self
Robin Carhart-Harris’s argument is that the Default Brain Network may be the source of what most adult people call the ‘ego’. This network is known as the Default Mode Network because, during our daily lives, this brain network becomes more active when we are idle.
The Default Mode is actually a really important part of our mental stability. This network is responsible for keeping our routines in check, making sure that our pending matters stay afloat, and that we’re not overlooking anything.
The mental activity generated by the Default Mode Network is usually stable and consistent day after day. This daily consistency in addition to the fact the DMN is the ‘standard’ mental voice, may contribute to the illusion that the Default Mode Network is the self.
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12:58 — [The Default Brain Network is]: “Arguably the best candidate we have for the neural substrates of the self, or the ego, or our identity and personality.” – Robert Carhart-Harris
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By analyzing the brains of participants who consumed psilocybin, Carhart’s team noticed that there was a process of renewal happening within the structure of the brain, almost like a general mind reset. This process of rebirth has been reported many times by psychedelic subjects.
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17:50 — “We can think of the mind or the brain is reset in the same way that you can think of a computer is malfunctioning and throwing up an error message and you are wondering what you can do. And then you press the reset button and it comes back working nice and smooth as it should.”
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In more recent years, Carhart-Harris has worked on building a more unified model of the workings of psychedelics in the brain. He founded the Psychedelic Research Group at Imperial College in London and focuses on the action of psychedelic drugs in the brain, and their clinical utility as aides to psychotherapy, with a particular focus on depression. He still studies the brain effects of LSD, psilocybin (magic mushrooms), and MDMA.
Robin Carhart-Harris will not be speaking at ICPR 2022, but his colleague and the new head of the Psychedelic Research Group at Imperial College will: David Nutt.
Notes about the author: Alexandre Perrella is a writer for Cabbanis!
‘The Netherlands can play a pioneering role in developing the right frameworks, limiting potential risks, and designing training programs,’ the Dutch health minister said.
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Ernst Kuipers, the new Dutch Minister of Health, Welfare, and Sports, has given his green light to more research in psychedelic therapy, citing “promising results” for typically difficult-to-treat mental illnesses through psychedelics-assisted therapy. His endorsement came in response to questions from three members of parliament from the Dutch political party D66. Kuipers summed up his stance on psychedelic research in a letter directed to the Speaker of the Dutch House of Representatives, and its content is factual and amenable to recent scientific results.
This is a departure for the Dutch government, which in recent years produced more prohibition-focused or avoidant language when it came to issues surrounding psychedelics. The new government has also announced that a state committee will look into the medical use of MDMA – a political compromise arising from the ongoing discussion in the Netherlands about the possible legalisation of MDMA for recreational use.
The new government’s health minister demonstrated conviction about the prominence psychedelic therapy will gain in global healthcare in the coming years, and envisions how the Netherlands could become a leader at the forefront of psychedelic research: “It is paramount that these and other potentially innovative treatments are safely accessible to the target population,” the minister writes. “The Netherlands is one of the leading countries in research into psychedelics in mental health care. In addition, the Netherlands can play a pioneering role in developing the right frameworks, limiting potential risks, and designing training programs for therapists. I am in favour of sharing earned knowledge with parties in the field across different countries.”
The Netherlands at the forefront of psychedelic research
Apart from MDMA, other psychedelic substances – such as psilocybin1 and ketamine2 – have also demonstrated promise. Kuipers strikes a more cautious tone when speaking about these compounds, affirming the need for more research due to the preliminary nature of current results: “Most of these substances are still in the investigative phase of research. […] It is up to the relevant field parties to follow up on these results. This concerns conducting the necessary research, completing the step-by-step registration process for approval of the substance, and the development of guidelines and protocols necessary for treatment.”
Kuipers further stresses the need for extensive education, the training of psychedelic therapists, and the need to better understand individuals engaged in self-experimentation. He adds that he is “willing to play a facilitating and advising role” in implementing psychedelic research and that his ministry has recently conducted exploratory meetings with researchers and mental healthcare institutions.
He envisions the Netherlands as playing a major role internationally in the coordination and promulgation of psychedelic research, writing that “[t]he Netherlands can stimulate cooperation in a European and international context. In addition, the Netherlands can draw attention to removing barriers in conducting research. In the framework of the United Nations Commission on Narcotic Drugs, I continue to advocate for the removal of barriers to therapeutic use and research into substances on United Nations drug convention lists.”
New Research
According to Kuipers, an estimated 1.2 million Dutch citizens currently seek curative mental healthcare each year. Another 215,000 citizens suffer from severe psychiatric illness, a segment of the patient population that is very difficult to treat with current therapies. Kuipers has announced he will allocate 35 million euros to mental healthcare research over the next four years, made available through the Dutch grant organisation ZonMw. Grants will support multidisciplinary studies focused primarily on clinical applied research.
The availability of these funds presents psychedelic researchers with a rare opportunity. Results from these new studies could further elucidate the therapeutic mechanisms by which psychedelics function, thereby putting their clinical application on firmer scientific footing. Ultimately, Kuiper’s initiative offers the promise of advancing the field beyond its “investigative phase” and imagines a not-too-distant future in which psychedelics are used as legitimate therapeutic agents in clinical contexts, offering hope to the millions who suffer from severe psychiatric illness around the globe.
Barriers to breakthrough therapy status
The three representatives of D66 asked further questions surrounding the current “breakthrough therapy status” of certain psychedelics in the United States. A breakthrough therapy designation is granted to a drug that treats a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug might demonstrate substantial improvement on clinically significant endpoints over available therapies.
Recently, the American Food and Drug Administration (FDA) granted ‘breakthrough therapy status’ to psilocybin for treatment-resistant depression and to MDMA for PTSD. Kuipers explains that a similar status within the Netherlands and other countries in Europe can be attained through organisations such as the European Medicines Agency (EMA).
The minister acknowledges the barriers that still exist for psychedelic research, like “a lack of financial resources for doing the necessary clinical research and developing an approved product for the patient. In addition, psychedelics are substances that are generally non patentable and thus do not fit the ordinary development and revenue model. The potential high costs for the therapeutic treatment with these substances (due to the large amount of hours therapists dedicate to patients during treatment) might also impede incorporating psychedelics as a standard treatment.”
The issue of the relative expense of psychedelic therapy bears further scrutiny. How, for instance, would the cost of psychedelic therapy compare to that of treatment as usual (TUA) if we take into account factors such as the economic burden of different psychiatric illnesses and/or disability-adjusted life years (i.e,. the number of years lost due to an illness)? To resolve the issue of financial expenditure, cost-effectiveness analyses of psychedelic therapy should be conducted, such as that performed in 20203. This study found that MDMA-assisted psychotherapy versus TUA per 1,000 patients produced savings of up to $103.2 million over 30 years including costs, and surmised that “third-party payers are likely to save money within three years by covering this form of therapy [MDMA].” This, however, is just the conclusion of one study, and the issue of financing deserves further investigation.
Central management and the Netherlands
Kuipers acknowledges the risks involved in the lack of central management of psychedelics. Possible risks include personal experimental use of psychedelics and the development of commercially exploitative practices that fail to the interests of patients first. Kuipers emphasises the urgency with which these questions need to be answered, and references the Dutch researchers and clinicians who authored Therapeutic use of psychedelics4: “[…] they can develop a framework for this new form of treatment by means of high quality guidelines, standards, and protocols.”
Finally, the new government of the Netherlands has called for more research into MDMA and the possible legalisation of it in the near future. Kuipers mentions that there will be a state committee specifically for MDMA. The state committee will “investigate the status of MDMA in the context of public health and provide advice surrounding the pros and cons of medicinal use by adhering to a multidisciplinary analysis, which takes into account potential risks for health, prevention, and the European context and its relevant treaties.” Kuipers expects to inform the House of Representatives of the committee’s findings in the second quarter of this year.
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References:
1. Davis, A. K., Barrett, F. S., May, D. G., Cosimano, M. P., Sepeda, N. D., Johnson, M. W., … & Griffiths, R. R. (2021). Effects of psilocybin-assisted therapy on major depressive disorder: a randomized clinical trial. JAMA psychiatry, 78(5), 481-489.
3. Marseille, E., Kahn, J. G., Yazar-Klosinski, B., & Doblin, R. (2020). The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD. PloS one, 15(10), e0239997.