FDA expands access to MDMA-assisted psychotherapy for PTSD

Thanks to the tireless efforts of the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), the US FDA is clearing the way for ten clinics around the United States to treat PTSD patients with MDMA. It's likely that the FDA will grant full approval for the therapy in 2020, reports New Atlas. From the article:

MAPS has previously hypothesized thousands of psychedelic-assisted psychotherapy clinics will open up across the United States. In the near future these clinics may not only administer MDMA for PTSD but also psilocybin, which is currently proving promising for a variety of conditions, including major depression.

The FDA approval for Expanded Access is yet another validation of MDMA-assisted psychotherapy’s safety and efficacy following extraordinarily positive early clinical trial results. Current Phase 3 trials are set to run until 2021 and complete market approval could come as early as 2022.

Image by DMTrott - Own work. Originally published in The Drug Users Bible [ISBN: 978-0995593688]., CC BY-SA 4.0, Link Read the rest

Scientists genetically engineer E. coli to produce the psychedelic psilocybin

Finally, researchers are again exploring the therapeutic benefits of psychedelics to treat the likes of depression, addiction, and obsessive-compulsive disorder. To provide pharmaceutical-quality compounds for clinical trials, scientists are developing new ways to produce the psychedelics. Chemical engineers at Miami University in Ohio have now genetically engineered E. coli to crank put psilocybin, the psychoactive ingredient in magic mushrooms. From Scientific American:

The modified microbes generated up to 1.16 grams of psilocybin per liter of culture medium—the highest yield to date from any engineered organism and a 10-fold increase over the next best attempt. Scaled up, the new method could produce psilocybin for potential therapeutic use.

“The number-one advantage is it's simply cheaper” than—or at least cost-competitive with—other methods, says lead study author Alexandra Adams, an undergraduate student in chemical engineering at Miami University in Ohio...

Adams and her colleagues engineered E. coli that incorporated three genes from the Psilocybe cubensis mushroom, enabling the bacteria to synthesize psilocybin from the cheap and easily obtainable precursor molecule 4-hydroxyindole, and then they optimized the process to produce the drug on a larger scale.

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Counterculture icon and psychedelic pioneer Ram Dass, RIP

Ram Dass -- counterculture icon, psychedelic pioneer, and spiritual guide -- has died at age 88. After turning on with his Harvard psychology colleague Timothy Leary in the early 1960s, Ram Dass (formerly Richard Alpert) became an intrepid explorer of higher consciousness and dedicated his life to teaching what he learned to the world. From Tricycle:

In Be Here Now, Ram Dass‘s first book for the masses, which has sold over 2 million copies since publication in 1971, he offered seekers an engaging, unconventional, slightly zany roadmap for finding a spiritual path and a more enduring connection to higher consciousness than a tab of acid could bring. From then on, in close to a dozen books and countless teachings, retreats, and podcasts, Ram Dass continued to share the wisdom of a journey that had long gone beyond personal transformation to embrace a cosmic worldview and social agenda...

“My life has been a dance between power and love,” he observed after the massive cerebral hemorrhage in 1997 that left the charismatic, preternaturally articulate teacher groping for words. “First part, till Harvard: power, power, power, power. Up until drugs, I thought power was the end all and be all, because I was a little individual. Then drugs: love, love, love, love. My first mushroom trip was so profound that I saw radiance was inside, and I said, ‘I’m home, I’m home, I’m home.'”

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Santa Claus is a psychedelic mushroom

One fantastic and wonderful origin theory of Santa Claus involves psychedelic mushrooms and shamanic rituals of the indigenous Sámi people who live in northern Finland. Paul Devereux wrote about this incredible hidden history in his fascinating 2008 book The Long Trip: A Prehistory of Psychedelia. Then, Brooklyn filmmaker Matthew Salton blew mainstream minds with this fantastic New York Times "Op-Doc" short video on the topic.

For more on psychedelic Santa, check out the following pieces by Greg Taylor at the Daily Grail:

• "Santa is a Psychedelic Mushroom: Were Modern Christmas Traditions Influenced by Shamanic Folklore?"

• Santa's Long Trip Read the rest

Magic mushrooms in a nasal spray

As scientists make great strides in their research on psychedelic therapies for depression, PTSD, OCD, addiction and other conditions, new ways to deliver the drugs are also emerging from laboratories. Oregon company Silo Wellness announced the availability of a new nasal spray for psilocybin, the psychoactive ingredient in magic mushrooms. The company conducted their research and formulated the product in Jamaica where psilocybin is legal. From the Silo Wellness press release:

The key to the nasal spray is that it bypasses the gut, going directly to the bloodstream through the nasal mucus membranes and eventually the liver for metabolizing. “Many psilocybin patients, particularly women, complain of upset stomach or vomiting when taking high-doses of mushrooms,” Board Advisor and Silo Wellness investor Becky Rotterman, a Missouri pharmacist, stated. “We want to bring this wonderful natural medicine first to Oregon and then the flyover states – to those who would be afraid to eat a handful of fungi and who feel more comfortable seeing their medicine in a familiar delivery modality, such as a metered-dose nasal spray...."

Regarding the expansion of legalization efforts, Arnold explained that “this is the sort of product that activists can discuss with their legislators to show that safe consumption is possible within a legal framework.”

“With proof of concept in hand, we are taking pre-orders and entertaining licensing proposals for research abroad and manufacturing for the product in advance of jurisdictions coming online legally, similar to Oregon’s proposed medical-marijuana-like psilocybin initiative,” COO Scott Slay, of Eugene, Oregon stated.

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Johns Hopkins Medicine launches major center for psychedelic drug research

The esteemed research institute and medical school Johns Hopkins Medicine is starting the Center for Psychedelic and Consciousness Research thanks to $17 million in private donations. The generous funders include Boing Boing pal and author Tim Ferriss, WordPress founder Matt Mullenweg, TOMS shoes founder Blake Mycoskie, and investor Craig Nerenberg. Psychedelics have tremendous unlocked therapeutic potential for the likes of severe depression, PTSD, obsessive-compulsive disorder, and alcoholism, What a wonderful, important, and worthy cause these individuals chose to support. From Johns Hopkins Medical:

In 2000, the psychedelic research group at Johns Hopkins was the first to achieve regulatory approval in the U.S. to reinitiate research with psychedelics in healthy volunteers who had never used a psychedelic. Their 2006 publication on the safety and enduring positive effects of a single dose of psilocybin sparked a renewal of psychedelic research worldwide.

Since then, the researchers have published studies in more than 60 peer-reviewed journal articles. Their research has demonstrated therapeutic benefits for people who suffer from conditions including nicotine addiction and depression and anxiety caused by life-threatening diseases such as cancer. It has paved the way for current studies on treatment of major depressive disorder. These researchers have also expanded the field of psychedelic research by publishing safety guidelines that have helped gain approval for psychedelic studies at other universities around the world and by developing new ways of measuring mystical, emotional, and meditative experiences while under the influence of psychedelics.

The group's findings on both the promise and the risks of psilocybin in particular helped create a path forward for the chemical's potential medical approval and reclassification from a Schedule I drug, the most restrictive federal government category, to a more appropriate level.

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Oakland, California decriminalized shrooms, peyote, and other psychoactive plants and fungi

Oakland, California is now the second city in the United States, following Denver last month, to decriminalize psilocybin mushrooms. Oakland City Council unanimously passed the resolution on Tuesday. From NPR:

Oakland's resolution is broader than Denver's. Denver's initiative decriminalized the use and possession of mushrooms containing the compound psilocybin, whereas Oakland's refers to "entheogenic plants" in general, which includes the mushrooms and other plants and fungi containing psychoactive substances.

The resolution says city money will not be used "to assist in the enforcement of laws imposing criminal penalties for the use and possession of Entheogenic Plants by adults." It says that investigating people for growing, buying, distributing or possessing the substances "shall be amongst the lowest law enforcement priority for the City of Oakland...."

(The substances') possible therapeutic effects were highlighted in an agenda report filed to City Council by the resolution's sponsor, Council member Noel Gallo.

"For millennia, cultures have respected entheogenic plants and fungi for providing healing, knowledge, creativity, and spiritual connection," the report states, saying that these plants may be beneficial for conditions such as substance abuse, anxiety and PTSD. "This initiative aims to empower the Oakland community by restoring their relationship to nature."

These substances are currently not legal under federal and state law.

"Oakland City Council Effectively Decriminalizes Psychedelic Mushrooms" (NPR) Read the rest

Denver voters decriminalize magic mushrooms

This morning's news reported that Denver's ballot measure to decriminalize psychedelic mushrooms had failed, but now that all the ballots have been fully counted we've learned that the Sunnies outvoted the Sadsters 51% to 49%.

From Forbes:

Its provisions prohibit the city government from using any resources to impose criminal penalties against adults over 21 years of age for personal use and possession of psilocybin, the active ingredient in so-called "magic mushrooms."

Initiative 301 also specifies that going after people for the mushrooms is the city's “lowest law enforcement priority” and establishes a review panel to assess and report on the effects of the change by early 2021.

The Denver measure doesn't trump federal law, however. Psilocybin and psilocin are on Schedule I of the Controlled Substances Act and federal law states that "person convicted of illegally possessing any controlled substance face penalties of up to 1 year in prison and a minimum fine of $1,000, or both." Read the rest

Drug paraphernalia that's 1,000-years-old still contains traces of coke and DMT

In a Bolivian rock shelter likely used 1,000 years ago for religious rituals, archaeologists found a collection of drug paraphernalia that still contains traces of psychoactive plants. A pouch made from three fox snouts likely contained a stash of leaves and seeds. From New Scientist:
(The items) include a 28-centimetre-long leather bag, a pair of wooden snuffing tablets, a snuffing tube, a pair of llama-bone spatulas, a textile headband, fragments of dried plant stems and a pouch made from three fox snouts stitched together. The snuffing tube and tablets feature ornate carvings of human-like figures.

Melanie Miller at the University of Otago, New Zealand, and her colleagues used mass spectrometry to analyse samples from the pouch and plant stems. They detected five psychoactive compounds: cocaine, benzoylecgonine (BZE), bufotenine, harmine and dimethyltryptamine (DMT).

The presence of these drugs suggests the pouch may have belonged to a ritual specialist or shaman with extensive knowledge of plants and their psychoactive properties, and used to hold leaves, seeds and other plant matter.

More in the scientific paper: "Chemical evidence for the use of multiple psychotropic plants in a 1,000-year-old ritual bundle from South America" (PNAS)

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Psychedelics pioneer Ralph Metzner, RIP

Pioneering psychonaut Ralph Metzner who co-led the seminal psychedelic research at Harvard University in the early 1960s with Timothy Leary and Richard Alpert (Ram Dass) and co-authored The Psychedelic Experience, has died at age 82. (Above image, Metzner at left with Leary.) Through his life, Metzner helped a great many people through his psychotherapist practice, spoke frequently on eco-consciousness, and also composed visionary ballads. (Erowid)

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US FDA approved chemical twin of dissociative psychedelic ketamine to treat depression

Earlier today, the FDA approved esketamine (brand name Spravato), a chemical twin of the dissociative psychedelic/anaesthetic ketamine (Special K), as a treatment for depression. Spravato comes in nasal spray form meant to be administered weekly or every other week depending on the severity of the patient's depression.

"There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said the FDA's acting director of the Division of Psychiatry Products, Dr. Tiffany Farchione, in a press release. "Because of [safety] concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient."

From National Public Radio:

Many doctors who have become comfortable offering ketamine for depression probably won't switch to esketamine, said Dr. Demitri Papolos, director of research for the Juvenile Bipolar Research Foundation and a clinical associate professor at Albert Einstein College of Medicine.

For the past 10 years, Papolos has been prescribing an intranasal form of ketamine for children and adolescents who have a disorder that includes symptoms of depression.

"I'm very pleased that finally the FDA has approved a form of ketamine for treatment-resistant mood disorders," Papolos said. He said the approval legitimizes the approach he and other doctors have been taking.

But he hopes that doctors who are currently using ketamine continue to do so. "It'll be a lot less expensive and a lot easier for their patients [than esketamine]," he said.

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Johns Hopkins researchers recommend reclassifying magic mushrooms from schedule I to IV drug

Based on a new study of the safety and abuse potential of psilocybin, the hallucinogenic drug in magic mushrooms, Johns Hopkins University School of Medicine researchers recommend that "psilocybin should be re-categorized from a schedule I drug—one with no known medical potential—to a schedule IV drug such as prescription sleep aids, but with tighter control." Read the rest

Apple's HyperCard was inspired by an acid trip

Pioneering engineer Bill Atkinson was the lead designer/developer of the Apple Lisa graphical user interface, creator of MacPaint and QuickDraw, and part of the original team that developed the Apple Macintosh. In 1985, Atkinson dropped acid and came up with HyperCard, the groundbreaking multimedia authoring program that was really a precursor to the first Web browser. Atkinson recently told Leo Laporte the story of this incredible LSD-fueled eureka moment. From Mondo 2000:

It seemed to me the universe is in a process of coming alive. Consciousness is blossoming and propagating to colonize the universe, and life on Earth is one of many bright spots in the cosmic birth of consciousness....

The street lamps reminded me of bodies of knowledge, gems of discovery and understanding, but separated from each other by distance and different languages. Poets, artists, musicians, physicists, chemists, biologists, mathematicians, and economists all have separate pools of knowledge, but are hindered from sharing and finding the deeper connections...

Knowledge, it seemed to me, consists of the “How” connections between pieces of information, the cause and effect relationships. How does this action bring about that result. Science is a systematic attempt to discover the “How” connections. Wisdom, it seemed to me, was a step further removed, the bigger perspective of the “Why” connections between pieces of knowledge. Why, for reasons ethical and aesthetic, should we choose one future over another?

I thought if we could encourage sharing of ideas between different areas of knowledge, perhaps more of the bigger picture would emerge, and eventually more wisdom might develop.

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Johns Hopkins University seeks DMT psychonauts who have met machine elves!

Neuroscience researcher Roland Griffiths at the Johns Hopkins University School of Medicine is leading a scientific study on "the experiences of people who have had encounters with seemingly autonomous beings or entities after taking DMT." If that's you, fill out the anonymous survey! Just say know.

From the Daily Grail:

Dr. Roland R. Griffiths is a professor in the Departments of Psychiatry and Neurosciences at the Johns Hopkins University School of Medicine. His main line of work has been studying the subjective and behavioral effects of mood-altering drugs, and has written over 360 journal articles and book chapters –e.g. “Psilocybin Can Occasion Mystical-Type Experiences Having Substantial and Sustained Personal Meaning and Spiritual Significance.” (Psychopharmacology, July of 2006), which proved instrumental in setting up trials for the testing of the emotional benefits of psylocibin among terminal patients.

So if you’ve had a tête à tête with one of Terence McKenna’s self-dribbling jeweled basketballs, please consider contributing to the Johns Hopkins study...

"Have you had an encounter with a seemingly autonomous entity after taking DMT?"

(image: "The Machine Elves" by seelingphan) Read the rest

Support the Terence McKenna archives!

Terence McKenna (1946-2000) was an ethnobotanist, psychedelic pioneer, philosopher, and shamanic scholar who boldly explored the mysteries of consciousness and the fringes of reason with rigor, wit, and generosity. Now, Kevin Whitesides with support of fellow travelers like BB pal Erik Davis are working hard "to collect, digitize, transcribe, store, and preserve the imprint of Terence McKenna's presence" in all media for the ages. You can help! Support the Terrence MckKenna Archives GoFundMe campaign! The incentives you can receive for participating are quite mind-blowing.

There are five major sub-projects at present, all under the banner of The Terence McKenna Archives:

1) A Collection Project: to find, collect, store, and preserve, either physical (or at least digital) copies of any material related to Terence McKenna. A full list of the physical & digital holdings are available at terencemckennaarchives.com.

2) A Transcription Project: to transcribe all of Terence McKenna's 500+ hours of audio/video material that is freely available on the web into a searchable database. This crowdsourced, volunteer-based project is already ongoing and incredibly successful and can currently be found at terencemckenna.wikispaces.com. If you would like to help contribute by transcribing Terence's talks, please join the effort there and on The Terence McKenna Transcription Project Facebook Page.

3) An Interview Project: to interview any family member, friend, colleague, acquaintances, workshop attendee, correspondent, interviewer, critic, collaborator, or any person suitably inspired or influenced by Terence McKenna.

4) TerenceMcKenna.com: Terence's son owns this domain and it currently houses the Terence McKenna Bibliography, but we need resources and talent in order to build into the online McKenna hub that it can ideally be, eventually hosting the searchable transcription database, an online digital archive, and much more.

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Vsauce went to Peru to experience ayahuasca

A friend and I were talking last night about ego dissolution (something we've both experienced). I was telling him about this recent Vox article that shares the author's first-hand account of an ayahuasca trip at Rythmia, a luxury "life advancement" resort in Costa Rica.

What really struck me about his tale is how he describes what he felt like on the fourth and final night (after drinking the most potent of all the brews):

I watch my entire life unfold as though it were projected on a movie screen. But it wasn’t my whole life; it was every lie, every counterfeit pose, every missed opportunity to say or do something true, every false act and ingratiating gesture, every pathetic attempt to be seen in a certain light...

The experience made me aware of how often we all do this. We do it at home, at work, at the grocery store, at the gym. Most interactions are either transactional or performative. No one wants to make eye contact, and most of the time people freak out if you really try. We’re too self-conscious to listen. We’re thinking about what we’ll say next or how we’re being perceived.

All the posturing destroys any chance for a genuine connection.

That passage reminds me a bit of what I experienced when I had an ego death a couple of years ago. My experience (which was not gained through ayahuasca, by the way) showed me the motives behind the people in my life, both past and present, and if they were with me or not. Read the rest

Trials confirm the use of psilocybin for depression without the "dulling" effects of traditional antidepressants

The prohibition on psychedelics was memorably described as "the worst case of scientific censorship since the Catholic Church banned the works of Copernicus and Galileo" by former UK Drugs Czar David Nutt, and despite the ban, there has been a consistent, determined, very promising (sometimes surprising) drumbeat of scientific papers about the use of psilocybin ("magic mushrooms") and other psychedelics in treating a range of chronic illnesses, including mental illnesses. Read the rest

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