Mind-altering ketamine becomes new pain treatment, despite little research or regulation

As U.S. doctors scale back their use of opioid painkillers, a new option for hard-to-treat pain is taking root: ketamine, the decades-old surgical drug that is now a trendy psychedelic therapy.

Prescriptions for ketamine have soared in recent years, driven by for-profit clinics and telehealth services offering the medication as a treatment for pain, depression, anxiety and other conditions. The generic drug can be purchased cheaply and prescribed by most physicians and some nurses, regardless of their training.

With limited research on its effectiveness against pain, some experts worry the U.S. may be repeating mistakes that gave rise to the opioid crisisoverprescribing a questionable drug that carries significant safety and abuse risks.

“There’s a paucity of options for pain and so there’s a tendency to just grab the next thing that can make a difference,” said Dr. Padma Gulur, a Duke University pain specialist who is studying ketamine’s use. “A medical journal will publish a few papers saying, ‘Oh, look, this is doing good things,’ and then there’s rampant off-label use, without necessarily the science behind it.”

When Gulur and her colleagues tracked 300 patients receiving ketamine at Duke, more than a third of them reported significant side effects that required professional attention, such as hallucinations, troubling thoughts and visual disturbances.

Ketamine also didn’t result in lower rates of opioid prescribing in the months following treatment, a common goal of therapy, according to Gulur. Her research is under review for medical journal publication.

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The Heirs to a Vault of Novel Psychedelics Take a Trip Into the Unknown

In April 1960, a Dow Chemicals biochemist named Alexander Shulgin consumed 400mg of a compound called mescaline, and had his first psychedelic experience. He saw “hundreds of nuances of color” that he had never seen before. “The world amazed me,” Shulgin later wrote. “I saw it as I had when I was a child. I had forgotten the beauty and the magic and the knowingness of it and me.” He found the encounter so extraordinary, that he dedicated the rest of his life to uncovering the secrets that psychedelic chemistry could contain. 

“I understood that our entire universe is contained in the mind and the spirit,” Shulgin recalled. “We may choose not to find access to it, we may even deny its existence, but it is indeed there inside us, and there are chemicals that can catalyze its availability.” However, it struck him as curious why scant work had been done on compounds, known as phenethylamines, which are similar to mescaline—the psychedelic derived from peyote that was first isolated in 1897. The trip, “unquestionably confirmed the entire direction” of his life, he wrote in his 1991 classic PiHKAL: A Chemical Love Story. “I had found my learning path.”

Shulgin, known as “Sasha,” was a hero to the psychedelic counterculture, but not necessarily a movement insider, went on to make the psychedelic experience more accessible than anyone else in history. He worked out of a ramshackle backyard lab on his 20-acre ranch in Lafayette, California, and discovered more than 200 new psychedelic compounds. A number of his compounds became popular, notably 2C-B (also known as “tripstasy”). He also tripped several thousand times himself, before he died in 2014 aged 88. 

He informally established the Alexander Shulgin Research Institute (ASRI), during the 1980s at a time when “the mere mention of psychedelics, even in the freedom-of-thought world of academia, was a career killer,” the ASRI says on its website. Today, the institute continues Shulgin’s psychedelic legacy. It was officially incorporated on Bicycle Day on 19 April 2021 by his wife Ann, before she died in 2022. Two of his long-time research colleagues, Paul Daley, and Nicholas Cozzi, took up leadership roles following Shulgin’s death. The institute is creating new psychedelics, which it is patenting, and scouring the vault of Shulgin’s creations for any overlooked gems.

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Advocates File California Ballot Initiative To Legalize Psychedelics For Medical, Therapeutic And Spiritual Use In 2024

Advocates in California filed a ballot initiative with state officials on Friday that would create a right “to obtain and use psychedelics for medical, therapeutic and spiritual purposes” with the recommendation of a doctor. It would also allow adults to possess and use the substances in their home as well as cultivate entheogenic plants and fungi on private property.

Known as the Psychedelic Wellness and Healing Initiative of 2024, the measure is the third psychedelics-related prospective citizen-led measure attempting to qualify for next year’s ballot. Another would legalize psilocybin for adult and therapeutic use, while a third would commit $5 billion to create a state agency focused on advancing research and development of psychedelic therapies.

Dave Hodges, an initiative organizer and the founder of the Church of Ambrosia, in Oakland, acknowledged in an interview earlier this month that the campaign behind the newest proposal is filing its paperwork later than initially hoped. Advocates won’t be able to start gathering signatures until the state attorney general’s office issues the proposal an official ballot title and summary, which can take more than a month.

Hodges said the goal of the proposal is to ensure broad access to psychedelics while ensuring a base level of safety.

“We aren’t just saying, ‘Everybody gets psychedelics!’” Hodges said. “We’re saying you gotta go talk to a doctor first, and if the doctor recommends that you try them, then you can come get them.”

Gov. Gavin Newsom’s (D) recent veto of an adult-use psilocybin bill passed by the legislature this session was a disappointment, he added, “but at the same time, I completely agree with it.” The governor said in his veto statement that he couldn’t support allowing access to psilocybin without first establishing therapeutic standards.

“My church now has over 100,000 members,” Hodges said. “If each of them could have gone and talked to a doctor before having access to psychedelics, I would have considered that a great thing.”

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Eureka, CA Decriminalizes Psychedelic Plant Medicines

Eureka, CA, has passed a resolution decriminalizing entheogens and psychedelic plant medicines, making it the sixth California city to do so and the second such city in Humboldt County.

The Eureka City Council unanimously approved an initiative last week to decriminalize plant medicines such as psilocybin mushrooms within city limits. The announcement came less than two weeks after CA Gov. Gavin Newsom vetoed an initiative which would have decriminalized psychedelics statewide. The City of Arcata, just a few miles to the north, voted to decriminalize in 2021 thanks to efforts by a group who also provided the language used in the Eureka resolution, Decriminalize Nature Humboldt.

According to an article in the Lost Coast Outpost, the resolution was passed without much trouble from the council, though a particular phrase was removed from the language of the bill. The council voted to remove language which seemed to endorse entheogenic plants’ ability to “catalyze profound experiences of personal and spiritual growth.” Not for nothing, but one of recently deceased Johns Hopkins professor Roland Griffiths’ first studies on psilocybin in 2006 was on psilocybin’s ability to induce mystical and spiritual experiences in the user. Much of Griffiths’ later work at Johns Hopkins has been referenced in similar legislative discussions surrounding the legality of psychedelics.

Other than the removal of the aforementioned phrase, the resolution was passed without much protest from the rest of the council members.There were some concerns voiced by local law enforcement representatives, mirroring Gov. Newsom’s concerns about potentially unforeseen consequences to the resolution. City Manager Miles Slattery, however, pointed out that he had consulted with the Arcata Police Department who reported no serious issues to him after just over two years of psychedelic decriminalization. He also pointed out that the City of Eureka only saw five cases of arrests related to entheogens in the previous year and almost every case was related to something more serious such as domestic violence. 

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Human Use Of Cannabis—For Food, Fiber And Psychoactive Effects—Stretches Back Millennia, New Report Says

A new paper in the European Journal for Chemistry traces the history of cannabis through “thousands of years of contact with mankind,” noting the plant’s legacy as a source of fiber, nutrition, medicine, spirituality and pleasure.

At the same time, it notes that cannabis “is perhaps one of the greatest controversies in contemporary humanity” and a key driver of the modern war on drugs.

The paper, “From ancient Asian relics to contemporaneity: A review of historical and chemical aspects of Cannabis,” was written by Gabriel Vitor de Lima Marques and Renata Barbosa de Olivera, of the pharmacy department at the Federal University of Minas Gerais in Brazil.

The cannabis plant appears to have first been used for its fiber, as a material for ropes and other manufactured goods, the authors wrote. Use of hemp fiber dates back to approximately 10,000 years ago in ancient Mesopotamia and to roughly 6,000 and 5,000 years ago in China and Kazakhstan, respectively.

Ancient peoples considered cannabis one of the five main grains, along with rice, soy, barley and millet, the paper continues. And once stalks were processed into hemp fibers, they became durable materials for ropes, sails and boat rigging, clothing, paper, animal husbandry and more.

“Used as a stunner to facilitate the capture of fish,” it says, “Cannabis is possibly the first plant to be cultivated for non-food purposes.”

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California Governor Newsom Vetoes Psychedelics Legalization, But Calls For New Bill On Therapeutic Access Next Year

The governor of California has vetoed a bill to legalize certain psychedelics and create a pathway to regulated access—a move that comes at a time when two states have already enacted comprehensive psychedelics policy reform and as two campaigns are working to put the issue on California’s 2024 ballot.

Gov. Gavin Newsom (D)—who was one of the most prominent and earliest lawmakers to call for an end to the war on drugs as mayor of San Francisco and later push for the legalization of cannabis as lieutenant governor of California—vetoed the bill, SB 58, from Sen. Scott Wiener (D) on Saturday.

In a veto message, the governor caveated that he wants the legislature to send him a new bill next year establishing guidelines for regulated therapeutic access to psychedelics and also consider a “potential” framework for broader decriminalization in the future. But at this stage, he’s unwilling to let the reform be enacted with his signature.

“Both peer-reviewed science and powerful personal anecdotes lead me to support new opportunities to address mental health through psychedelic medicines like those addressed in this bill,” Newsom said in a veto message on Saturday. “Psychedelics have proven to relieve people suffering from certain conditions such as depression, PTSD, traumatic brain injury, and other addictive personality traits. This is an exciting frontier and California will be on the front-end of leading it.”

“California should immediately begin work to set up regulated treatment guidelines—replete with dosing information, therapeutic guidelines, rules to prevent against exploitation during guided treatments, and medical clearance of no underlying psychoses,” he continued.  “Unfortunately, this bill would decriminalize possession prior to these guidelines going into place, and I cannot sign it.”

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Psychedelics plus psychotherapy can trigger rapid changes in the brain

The human brain can change—but usually only slowly and with great effort, such as when learning a new sport or foreign language, or recovering from a stroke. Learning new skills correlates with changes in the brain, as evidenced by neuroscience research with animals and functional brain scans in people. Presumably, if you master Calculus 1, something is now different in your brain. Furthermore, motor neurons in the brain expand and contract depending on how often they are exercised— a neuronal reflection of “use it or lose it.”

People may wish their brains could change faster—not just when learning new skills, but also when overcoming problems like anxiety, depression, and addictions.

Clinicians and scientists know there are times the brain can make rapid, enduring changes. Most often, these occur in the context of traumatic experiences, leaving an indelible imprint on the brain.

But positive experiences, which alter one’s life for the better, can occur equally as fast. Think of a spiritual awakening, a near-death experience or a feeling of awe in nature.

Social scientists call events like these psychologically transformative experiences or pivotal mental states. For the rest of us, they’re forks in the road. Presumably, these positive experiences quickly change some “wiring” in the brain.

How do these rapid, positive transformations happen? It seems the brain has a way to facilitate accelerated change. And here’s where it gets really interesting: Psychedelic-assisted psychotherapy appears to tap into this natural neural mechanism.

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California Governor Signs Bills To Let Doctors Prescribe Psilocybin And MDMA If They’re Federally Rescheduled And To Change Marijuana Testing Rules

California Gov. Gavin Newsom (D) has signed a bill that would allow doctors to immediately start prescribing certain currently illicit drugs like psilocybin and MDMA if they’re federally rescheduled, and he also approved separate legislation to amend THC variance testing requirements for marijuana.

The governor signed off on the measures—which are just two of more than a dozen cannabis and drug policy reform proposals on his desk—on Saturday.

AB 1021, sponsored by Assemblymembers Buffy Wicks (D), Isaac Bryan (D) and Corey Jackson (D), says that, if the federal government reschedules any Schedule I drug under the Controlled Substances Act (CSA), California health professionals will automatically be able to legally prescribe and dispense it.

This could be especially relevant to the psychedelics psilocybin and MDMA, which have been designated as breakthrough therapies by the federal Food and Drug Administration (FDA) and are expected to be approved for medical use as early as next year.

Following a recent Phase 3 clinical trial, a peer-reviewed study published in the journal Nature last month found that treatment with MDMA reduced symptoms in patients with moderate to severe PTSD. The findings mean federal regulators could consider approving the drug for wider use as soon as next year.

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House Approves Psychedelic Research And Marijuana Labeling Amendments As Part Of Spending Bills

The U.S. House of Representatives has voted to approve a series of psychedelics and marijuana amendments as part of spending bills, and a Democratic congressman is again seeking to revise separate measures to end cannabis testing for federal workers.

On the same day that a Senate committee passed a marijuana banking bill, the House took up amendments to appropriations legislation that were recently cleared for floor consideration by the Rules Committee.

Both psychedelics measures were attached to a spending bill covering the Department of Defense (DOD) in voice votes on Wednesday.

One, sponsored by Reps. Morgan Luttrell (R-TX) and Dan Crenshaw (R-TX), would provide $15 million in funding for DOD to carry out “Psychedelic Medical Clinical Trials.” The second amendment, from Crenshaw alone, lays the parameters for the trials, which would involve active duty service members with post-traumatic stress disorder (PTSD) or traumatic brain injuries (TBI). The Defense Health Agency would need to send a report to Congress with its findings.

Notably, a Democratic congresswoman argued against the proposal, citing DOD concerns about trials involving active duty service members.

Luttrell said ahead of the voice vote on his amendment that he can “personally attest to the benefits in treating post-traumatic stress, traumatic brain injury and chronic traumatic encephalopathy through the use of psychedelic substances.” The congressman, who is a military veteran, has previously disclosed his own experience with psychedelic-assisted therapy.

“There’s a stigma that exists within the [House] that I believe stems from a lack of education experience around the clinical use of plant-based, or psychedelic, medications,” he said. “I understand that when many of my colleagues hear the word ‘psychedelics,’ they think of mushrooms and so on. This isn’t what we are talking about today.”

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