MAPS Granted Historic Approval to Conduct Phase-3 Trials for MDMA-Assisted Therapy

It seems the day when MDMA (ecstasy) gets widely regarded as a valuable therapeutic tool for the treatment of serious psychological problems, instead of an illegal party drug, is now closer at hand. Last week MAPS --the Multidisciplinary Association for Psychedelic Studies-- issued a press release announcing they had reached an agreement with the FDA to grant MDMA the designation of 'Breakthrough Therapy', and are now ready to design two Phase 3 trials of MDMA-assisted psychotherapy for patients with severe PTSD (post-traumatic stress disorder).

These new trials will be conducted next year, as a follow-up to a previously completed Phase 2 trial in which 107 subjects participated. After three sessions of MDMA-assisted psychotherapy, 61% no longer qualified for PTSD, and at a 12-month follow up, 68% of the subjects were found completely cured of PTSD. Now let those figures sink in for a moment: Patients who had been suffering from extremely-deteriorating stress symptoms FOR DECADES, who had resorted to all sorts of prescription pills to counter the symptoms, and countless hours of traditional psychotherapy to no avail, were cured forever of their fears and phobias after taking MDMA three times.

"Reaching agreement with FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team," said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation (MPBC). "Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3."

The FDA's unusual openness to acknowledge the huge therapeutic potential of what is still considered a Schedule I drug in most countries, is sadly the result of the continuous belic conflicts in the Middle East for the last 16 years. With hundreds of veterans returning home from Iraq and Afghanistan suffering from the brunt of traumatic experiences and unable to successfully reintegrate to civilian life, there's a big political push to try unorthodox methods to help all these young men and women who served their country. All this is mentioned on an article published on the Washington Post on the same day MAPS issued its press release.

This is not only great news for people currently suffering from PTSD or other issues which have proven too resilient for traditional therapies, but also a major victory for MAPS and its founder, Rick Doblin; a man who has been fighting for the legitimacy of psychedelic treatments for 45 years. Over at Narratively there's a great article delving into Rick's career, which talks about how his conviction that psychedelics have the potential to cure some of the world's deepest ills, has pushed him to go through all the legal red tape and stigma these substances have been carrying since the 1960's, conducting scientific studies and publishing papers in reputable journals, so that one day the Western world will finally makes its peace with entheogens, and openly regard them the same way our ancestors did for thousands of years: As a gift of the gods to mankind.

Rick Doblin at Burning Man, accompanied by author Daniel Pinchbeck to the left, and psychedelic artist Alex Grey to the right.


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Otherworlds: A New Book Exploring the Links Between Psi and Psychedelics

Book cover for Otherworlds: Psychedelics and Exceptional Human Experience

Our good friend (and Darklore contributor) Dr David Luke has a new book available covering the strange lands that live between shamanism and parapsychology: Otherworlds: Psychedelics and Exceptional Human Experience (Amazon US / Amazon UK). Here's the blurb:

A psychonautic scientific trip to the weirdest outposts of the psychedelic terrain, inhaling anything and everything relevant from psychology, psychiatry, parapsychology, anthropology, neuroscience, ethnobotany, ethnopharmacology, biochemistry, religious studies, cultural history, shamanism and the occult along the way.

Staring the strange straight in the third eye this eclectic collection of otherworldly entheogenic research delivers a comprehensive and yet ragtaglledy scientific exploration of synaesthesia, extra-dimensional percepts, inter-species communication, eco-consciousness, mediumship, possession, entity encounters, near-death and out-of-body experiences, psi, alien abduction experiences and lycanthropy. Essentially, its everything you ever wanted to know about weird psychedelic experiences, but were too afraid to ask…

David is a former president of the Parapsychology Association who has published almost one hundred papers on transpersonal experiences, anomalous phenomena and altered states of consciousness - so he knows his stuff.

Links: Grab a copy of Otherworlds from Amazon US or Amazon UK

Lectures on 'Psychedelic Consciousness' from Breaking Convention 2017

The fine folks of Breaking Convention, a multidisciplinary conference on psychedelic consciousness held annually in Britain for the last four years, have kindly uploaded a bunch of videos from this year's instalment (held just a couple of weeks ago) that I'm sure many Grailers will be interested in.

I've embedded two of the videos in this post. Above, Rupert Sheldrake on "Psychedelic Experience And Morphic Resonance":

When people take psychedelic drugs, these drugs have a variety of effects on their brain activity. These effects are similar to those in people who have taken the same drugs in the past. According to the hypothesis of morphic resonance, similar patterns of activity in the past resonate with similar patterns in the present. This opens up the possibility that psychedelic experience includes a resonance from people in the past who have taken the same drugs. This may set up a kind of collective memory for each kind of psychedelic experience. Present experiences may tap into this collective memory and in turn contribute to it. This hypothesis is experimentally testable.

And below is Dennis McKenna's talk, "Is DMT A Neurotransmitter For The Gaian Brain?".

The possible functions of endogenous DMT as a neurotransmitter or regulatory neurohormone in mammalian physiology are incompletely understood, and a matter of controversy. Its ubiquity in nature, however, suggests it may function at the biospheric level as a messenger molecule. The planetary ecosystem – sometimes romantically likened to Gaia, the feminine Mother of all life in Greek mythology – is a complex homeostatic system that is regulated and stabilised by complex feedback loops and symbiosis. These processes operate via signal transduction, the exchange of information mediated by molecular messengers. Neurotransmitters are one of many kinds of signal-transducing molecules in the body, but in ecosystems, photosynthetic plants produce a vast array of secondary products that mediate their interactions with virtually all organisms in the environment, including humans. In this talk I will suggest that DMT and the ‘family’ of related tryptamines – may specifically target the big-brained primates to trigger cognitive evolution.

These are just two of the talks available - you can check out everything posted so far (30+ videos!) over at the Breaking Convention YouTube channel - and it might be worth subscribing so that you know when new videos are posted.

Massive thanks to the Breaking Convention peeps for doing this, it gladdens the heart of this Antipodean stuck on the other side of the planet.

Link: Breaking Convention YouTube Channel

Is Harvesting Medicinal Plants for 'Shamanic Tourism' Sustainable?

Ayahuasca preparation (photo by Heah, CCSA3 licence)

In recent years there has been a surge in so-called 'medical' or 'shamanic' tourism, with people from Western countries visiting retreats in foreign locations - such as the Amazon - to partake in indigenous ceremonies involving plant brews. But an overlooked element of such tourism is the question of whether this higher level of plant harvesting is sustainable.

Long-time Grailer Michael Coe, a graduate student working on his PhD in ethnobotany, is conducting research to try and answer this important question. As a recipient of the prestigious Richard Evans Schultes Award he has been able to partially fund his work already, but he is also seeking extra crowd-funding assistance for his research from the community:

Certain plant species are fundamental to the identity and longevity of cultural groups. Culturally important medicinal plants that are used for multiple purposes and have gained global attention are expected to be harvested frequently. I will identify medicinal plants that are culturally irreplaceable for local healers in Peru but that are used in medical tourism, and use mathematical models to investigate if and how harvesting these plants for medical tourism can be sustainable.

Michael's research is endorsed by the likes of Luis Eduardo Luna and Dennis McKenna, who notes that Michael's "important ethnobotanical fieldwork is a major undertaking, to understand the ecological and environmental context for the medicinal complex associated with ayahuasca."

So if you'd like to help out a fellow Grailer doing legit scientific research on an important topic, head over to his page on and help him reach his funding goal!

Link: Is Harvesting Medicinal Plants for Medical Tourism Sustainable?

Tracking Down the Secret Drugs of Buddhism

Buddhist goddess, or mushroom?

Did Buddhists of ancient times use shamanic plants and mushrooms in their sacred rituals? This is the question that Mike Crowley attempts to answer in his new book Secret Drugs of Buddhism. The book looks at the central role which psychedelics have played in Indian religions, beginning with the legendary soma, and follows the trail all the way to amrita, the sacramental drink of Vajrayāna Buddhism.

A glance at the titles of Vajrayāna scriptures will find the word amrita again and again. Many Vajrayāna deities have amrita as part of their name and a liquid called amrita is frequently visualized in Vajrayāna meditations. Almost all the early teachers of the Vajrayāna are depicted holding skull-cups of amrita. Two "skull-cups" of amrita adorn Vajrayāna altars and a drink called amrita is consumed at all major Vajrayāna rituals. Hundreds of Vajrayāna deities are said to carry amrita in some form, whether in a skull-cup, vase, flask or bowl.

Consider, for example, the prominent meditation-deity Hevajra. He is usually described and depicted as having sixteen arms with every hand holding a skull-cup filled with amrita and in one of his several variants he and his trantric consort arise out of the amrita itself.

And yet, despite multiple references in Vajrayāna literature and near-ubiquitous depictions in Vajrayāna art, you may be forgiven for never having heard of amrita before. If you are, as I am myself, a practicing Vajrayānist, then you may have performed the Vajrasattva purification practice in which the body is (mentally) filled with amrita. But the actual nature of amrita, its origin and history, are rarely discussed, if at all. In fact, even a standard textbook which provides a detailed account of Vajrayāna Buddhism as practiced in India and Tibet has managed to overlook it entirely.

Secret Drugs of Buddhism sets out to remedy this 'blind-spot' in the understanding of ancient Buddhist practices, pointing out the importance of amrita to the Vajrayan Buddhist tradition, and even offers suggestions for the ingredients of the original, psychoactive potion.

In telling the story of amrita, this book provides a new perspective on the origins of the Vajrayāna itself and, in the process, it resolves a few puzzles of tantric iconography (e.g. the role of peacocks, wheels and water-buffaloes) as well as offering an explanation for the previously inexplicable "crown-bump" deities.

It must be said that, in many cases, Buddhist references to amrita are simply an allusion to a legendary "elixir of immortality" and nothing more. Such turns of phrase as "the nectar of my teacher's words" may be considered as expressions of devotion or mere literary tropes, but not references to a physical potion. On the other hand, there are abundant instances in which amrita (whether actually drunk or merely visualized in a meditation) is associated with "bliss" or even "intoxication". In these instances we may clearly perceive indications that a draft of amrita was expected to induce a state of "blissful" intoxication - at least in the historical past. Yet, as we will see, the drinking of a drug potion called amrita was an essential component of the original Vajrayāna practice.

The book is full of fantastic insights and speculation, such as the proliferation of 'parasol' imagery and multi-armed deities fanning their limbs about in a circle in Buddhist artwork - both rather close analogues to the distinctive shapes and anatomy of mushrooms (it seems so obvious once it is pointed out). Secret Drugs of Buddhism also features a short foreword from Ann Shulgin and colour plates illustrating points made in the book.

Link: Secret Drugs of Buddhism at Amazon US

Hallucinogenic Honey Hunters of Nepal

If you've read Paul Devereux's wonderful book The Long Trip: A Prehistory of Psychedelia, you'll know how prevalent the use of shamanic plants was throughout the ancient world. But what about the use of hallucinogenic honey?

Nepal’s Gurung people live mostly in small villages in the vast Annapurna mountain ranges. In this remote region, they practice an ancient tradition of honey hunting where they descend towering cliffs on handmade ladders, to harvest honey nestled under jagged overhangs.

In spring, the Gurung’s honey contains a rare substance called grayanotoxin from rhododendron flowers that’s known for its intoxicating effects. While some accounts say it’s a deadly poison, others refer to it as an aphrodisiac, powerful medicine, and a hallucinogenic drug.

VICE travelled deep into the Annapurna mountains to join a Gurung village on their spring hunt and understand Mad Honey's effects.

The use of 'mad honey' wasn't just restricted to Nepal though; people in Turkey, Japan, Brazil, North America, and various parts of Europe have over the years been intoxicated by hallucinogenic honey.

Echoes and the Beast: Sinister Fractal Animation

Who knew the Sicario soundtrack would be so suited to a DMT trip? ECHOES, embedded above, "is an exploration in the infinite nature of fractal geometry" via 3D rendering, set to Jóhann Jóhannsson's "The Beast". Sinister non-Euclidean geometry to satisfy anybody's inner Lovecraftian...

(via Boing Boing)

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Archaeology Continues to Reinforce the Truth That Human History Has Been One Long Trip

Cannabis leaves

A recent paper on ancient cannabis use has made news this week, with some fascinating insights into its origins and spread through Asia and Europe. You can read a good summary of the research at the New Scientist link, so no need for me to rewrite it here.

What did catch my attention though is the following image from the paper, which maps archaeological sites in Eurasia that have been found to contain cannabis remains that date to more than 3000 years ago (ie. 1000 BCE).

Ancient Eurasian sites containing cannabis remains

What this clearly shows is how widespread the usage of cannabis was in ancient times, with some of the dates stretching back well before the advent of written records. In his wonderful book The Long Trip: A Prehistory of Psychedelia*, Paul Devereux offers fascinating insights into how not only cannabis, but many other psychoactive plants, have been used the world over for millennia, often for ceremonial and/or religious/mystical reasons. It is one hell of an eye-opening read, especially for those who think 'tripping' was something that started with the counterculture of the 1960s, and I can't recommend it highly enough (no pun intended)!

Understanding this fact makes modern culture's outlawing of many of these plants as even more nonsensical than it already is. Our ancestors across the globe have actively used these plants as both physical and spiritual medicine for at least 10,000 years, but suddenly in the last few decades our governments and law-makers have seen fit to not just ban them from human consumption, but to make them illegal and even imprison people who choose to use them.

It is an absolute joke that such laws continue to exist - persecuting those wishing to explore their own mind - when prominent political leaders (the last three U.S. presidents), scientists (Carl Sagan, Francis Crick, Oliver Sacks etc.), tech leaders (Apple's Steve Jobs etc.) and artists and musicians (too long a list to even begin) have all admitted to using psychoactives, and in some cases have been passionate advocates for their use and benefits.

That is certainly not to dismiss the dangers that such mind-altering substances can sometimes pose. But as long as no-one else is being hurt by a person's decision to explore their own mind with psychoactives, I don't see how it is any business of the government, or law enforcement, to stop people from doing so (let alone imprison them for doing it!).

The laws are a nonsense, and it's far beyond time for us to state that plainly and make the necessary changes. The story of human history is one of exploring and expanding our minds to uncover new ideas and understand ourselves better, and the archaeological record continues to reinforce the fact that psychoactive plants have been an integral part of that entire history.

* Full disclosure: 'The Long Trip' is a release of Daily Grail Publishing.

Long-term Immersion in the DMT Realm Through Controlled Intravenous Injection

Collective Vision, by Alex Grey

In recent decades usage of the psychedelic substance N,N-dimethyltryptamine (DMT) has grown considerably, and its intriguing effects have even been the subject of a study by Dr. Rick Strassman. In his book DMT: The Spirit Molecule, Strassman recounted many of the strange 'entity encounters' experienced by participants in his scientific trial, but noted that it was difficult for the experiences to be studied in depth due to the speed of the 'trip' (sometimes described as being 'shot out of a cannon' into a parallel universe before being quickly pulled back into reality).

Strassman's interest in the topic has not waned over the years, and in a new paper - co-authored with Andrew Gallimore - he has suggested a new method of delivering DMT that might sustain the experience for a longer period - effectively immersing study participants in the DMT realm, in much the same way that the application of general anaesthesia keeps medical patients immersed in unconsciousness.

"[DMT] users consistently report the complete replacement of normal subjective experience with a novel 'alternate universe,' often densely populated with a variety of strange objects and other highly complex visual content, including what appear to be sentient 'beings'," Strassman and Gallimore note. "The phenomenology of the DMT state is of great interest to psychology and calls for rigorous academic enquiry":

The extremely short duration of DMT effects—less than 20 minutes—militates against single dose administration as the ideal model for such enquiry. Using pharmacokinetic modelling and DMT blood sampling data, we demonstrate that the unique pharmacological characteristics of DMT, which also include a rapid onset and lack of acute tolerance to its subjective effects, make it amenable to administration by target-controlled intravenous infusion. This is a technology developed to maintain a stable brain concentration of anaesthetic drugs during surgery. Simulations of our model demonstrate that this approach will allow research subjects to be induced into a stable and prolonged DMT experience, making it possible to carefully observe its psychological contents, and provide more extensive accounts for subsequent analyses.

Link: "A Model for the Application of Target-Controlled Intravenous Infusion for a Prolonged Immersive DMT Psychedelic Experience

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Ayahuasca in Australia

Australian broadcaster SBS recently reported on the use of ayahuasca in 'the lucky country' (video embedded above), which for a change gave some serious screen time to people who used the shamanic brew for self-improvement. One of those they talked to was ayahuasca 'facilitator' Julian Palmer - author of the book Articulations: On The Utilisation and Meanings of Psychedelics - who has over the years championed personal exploration of the mind using shamanic plants.

The feature also mentioned an upcoming meeting of the Therapeutic Goods Administration (TGA) at which they will be reviewing submissions "to legalise a small amount of DMT for religious ceremonies". While those who think shamanic plants should be legal to use might feel that this is an exciting step forward, it may not be quite as big a deal as it sounds. Respected Australian ethnobotany figure Torsten Wiedemann has posted a detailed critique of this submission. Some of his points include:

1) I am not sure what the application is trying to achieve. The TGA schedules are not a law. They are merely recommendations to the states which have ultimate control over the schedules under the state health acts. At best the proposal could provide for a federal guide, but I very much doubt the states will simply go along with it. Having some state based ministerial support would have been crucial for this.

2) There were suggestions that the TGA is taking this seriously simply because they tabled it. They did not decide on this process. All applications to the TGA have to be considered and decided upon by the delegate. By making the application they have no choice but to process it. There have been frivolous/ridiculous/unwinnable applications in the past, so the mere acceptance means nothing and we should not read anything into that.


8) Much has been made of the religious aspect. 'religious purposes' was a big issue in the USA and some other countries, but has little meaning in Oz. Our federal constitution only guarantees that the federal government can't make laws that discriminate on the basis of religion, but it does not have any control over state law [which is what the TGA schedules are empowered by]. A constitutional scholar friend of mine tells me that a TGA ruling against the proposal is not an infringement of the constitution. There may be recourse under state charters, but so far nothing like that has been successful. I have been saying for years that state support is needed to make progress on this because ultimately these are all state law matters. I think the federal approach is a waste of time unless there is a plan on launching a constitutional challenge in the Northern Territory or ACT. The hopeful view of translating religious freedom exemptions to australia is not likely to be of any merit.

9) My friends in law enforcement policy tell me that DMT is very much on the agenda - and not in a good way. The TGA will toe the line of the federal drugs council [whatever the name is escapes me right now] which is focussing to come down harder on DMT rather than to weaken their stance. The TGA has no interest or incentive to buck the trend. I am not going to waste any time on making a submission as I do not see any chance of voluntary rescheduling (ie without a court case). And even if I was wrong then rescheduling by the TGA achieves nothing in practical terms. I see the only viable options for progress on this issue via the victorian charter or a federal constitutional case. I also do not see any level of government doing this voluntarily - like so many progressive policies this needs to be imposed by a court.

(Read the full post)

In short: some natural plants, and exploration of your own consciousness, remain illegal things in the year 2016, and may soon be cracked down on even harder.