Tag: psychedelics

Why Psychedelic Drugs May Become a Key Treatment for PTSD and Depression

While it has been referenced throughout history, notably in World War I, post-traumatic stress disorder (PTSD) as we know it today was first described as a distinct diagnosis after World War II among individuals who had survived Nazi concentration camps. The patients came home experiencing anxiety, depression and nightmares. They were frequently startled. In a paper synthesizing some of these early observations in 1963, psychiatrist Paul Chodoff wrote, “Perhaps the most nearly universal and most characteristic symptom was an obsessive rumination state in which the patient was more or less constantly preoccupied with recollections of, and ruminations about, his experiences during persecution, and about family who had died or been killed.” Psychiatrists tested a variety of treatments from drugs to exposure therapy for what Chodoff referred to as “concentration camp syndrome.”

More than 70 years after the initial observations, patients diagnosed with PTSD today still have few treatment options; most likely they will be prescribed a combination of therapy and antidepressant drugs. For some patients, these treatments make a positive difference in their quality of life, but many others continue for years without relief from nightmares, flashbacks, severe guilt and anxiety that can come with the condition. According to the U.S. Department of Veterans Affairs, about 6 percent of Americans will be diagnosed with PTSD at some point in their lives, whether they served in the military or not. While PTSD is often associated with traumas from war, it can also refer to symptoms after other traumatic experiences such as being involved in a serious accident, witnessing death or injury or being a victim of sexual assault.

Patients and scientists have longed for more options. “How many drugs are registered [in the U.S. and Europe] for PTSD?” asks Eric Vermetten, a psychiatrist at the University of Leiden in the Netherlands and a military veteran himself. “The answer is two. And when were they registered? 21 years ago. That’s 21 years, we haven’t had any new drugs registered for PTSD.”

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80 Bipartisan Lawmakers Push FDA To Seriously Consider Approving MDMA-Assisted Therapy

A bipartisan and bicameral coalition of congressional lawmakers is expressing urgency to the federal government as it looks into the possibility of authorizing MDMA-assisted therapy, particularly as it concerns veterans with severe mental health conditions.

A total of 80 members of Congress—including 19 senators and 61 representatives from the House—sent separate letters to the Biden administration and the head of the Food and Drug Administration (FDA) this past week, urging serious consideration of approving the psychedelic as a treatment option for post-traumatic stress disorder (PTSD).

MDMA is “one of the most promising and available options to provide reprieve for veterans’ endless PTSD cycle,” the Senate letter says, noting that FDA has already designated it as a breakthrough therapy.

This comes about a month after an FDA advisory panel rejected an application to authorize MDMA-assisted therapy. Bipartisan lawmakers separately staged an event at the U.S. Capitol calling for the MDMA approval and also launched an art installation memorializing military veterans who die by suicide.

“FDA should remain firmly anchored in scientific evidence and data when evaluating new treatments,” the new letter, led by Sens. Michael Bennet (D-CO), Thom Tillis (R-NC), Kyrsten Sinema (I-AZ) and Rand Paul (R-KY), says. “The potential for groundbreaking advancements in PTSD treatment is within reach, and we owe it to our veterans and other affected populations to review these potentially transformative therapies based on robust clinical and scientific evidence.”

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The DEA Wants To Ban Scientifically ‘Crucial’ Psychedelics Because People Might Use Them

You probably have never heard of 2,5-dimethoxy-4-iodoamphetamine (DOI), let alone heard that it is commonly abused. Yet the Drug Enforcement Administration (DEA) wants to ban the synthetic psychedelic, a promising research chemical that has figured in more than 900 published studies, by placing it in Schedule I of the Controlled Substances Act, a category supposedly reserved for drugs with a high abuse potential and no recognized medical applications—drugs so dangerous that they cannot be used safely, even under a doctor’s supervision. Students for Sensible Drug Policy (SSDP), which defeated a previous DEA attempt to ban DOI in 2022, is determined to stop that move again.

On Tuesday, acting on behalf of more than 20 scientists, SSDP filed a prehearing statement objecting to DOI’s placement in Schedule I. That step, SSDP notes, would impose “onerous financial and bureaucratic obstacles on researchers,” since “obtaining a Schedule I license involves a daunting array of red tape and substantial costs, which can be prohibitive for many research institutions, particularly smaller labs and academic departments.” SSDP also opposes the scheduling of another psychedelic, 2,5-dimethoxy-4-chloroamphetamine (DOC), that is covered by the same proposed rule, which the DEA published on December 13.

“DOI and DOC are important research chemicals with basically no evidence of abuse,” says SSDP attorney Brett Phelps. “We are excited to fight on behalf of SSDP scientists so that they can continue the critical work they are doing with these substances.”

Phelps is working with Denver attorney Robert Rush, who represents University of California, Berkeley, neuroscientist Raul Ramos. “The DEA’s attempt to classify DOI, a compound of great significance to both psychedelic and fundamental serotonin research, as a Schedule I substance exemplifies an administrative agency overstepping its bounds,” Rush says. “The government admits DOI is not being diverted for use outside of scientific research yet insists on placing this substance in such a restricted class that it will disrupt virtually all current research.”

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Psychedelic Mushrooms May Have Contributed To Early Development Of Human Consciousness, Study Concludes

A new paper exploring the role of psilocybin mushrooms in the evolution of human consciousness says the psychedelic has the “potential to trigger significant neurological and psychological effects” that could have influenced the development of our species over time.

The literature review, which authors said draws on “a multidisciplinary approach spanning biology, ethnobotany and neuroscience,” examined studies involving psilocybin and human consciousness published in multiple journals in different fields. Their 12-page report highlights views that mushrooms played a crucial role in getting humans to where we are today.

“The hypothesis that psilocybin mushrooms may have intervened as a factor in the evolution of human consciousness, either as catalysts of mystical experiences or as drivers of cognitive processes, raises profound reflections on the ancestral interaction between human beings and their environment,” the authors wrote, according to a translation from the original Spanish. “The origin of human consciousness is one of the great questions facing man, and the material collected indicates that psilocybin may have contributed to its early development.”

As humans’ ancestors moved from forested environments into grasslands, they encountered more hoofed animals—and their excrement. In that excrement, they likely found mushrooms, including psilocybin mushrooms, says the study, citing researchers such as Terrence McKenna, who explored the so-called “stoned ape” theory that psychedelics helped spur human development.

Consuming mushrooms may have subsequently influenced pre-human hominids’ brains in all sorts of ways, authors wrote, such as improving hunting and food-gathering as well as increasing sexual stimulation and mating opportunities.

Changes like those, combined with the effects of psilocybin on human consciousness and brain function, could have expanded the human mind, “allowing us to transcend our basic perception and embrace creativity, introspection and abstract thinking” and potentially influencing language development, the study, published last month by the Miguel Lillo Foundation, a research organization in Argentina, says.

“Considering the importance of psilocybin mushrooms in the interaction with human consciousness, it is crucial to explore both their brain and evolutionary implications,” the authors—Jehoshua Macedo-Bedoya of the University Nacional Mayor de San Marcos, in Lima, Peru, and Fatima Calvo-Bellido of the Pontifical Catholic University of Peru—concluded.

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California Lawmakers Kill World’s Most Marginal Psychedelics Reform

The world’s most modest psychedelics reform has failed in the California Legislature once again.

Yesterday, the sponsors of a bill that would have allowed three California counties to run temporary pilot programs through which veterans and first responders could be administered psilocybin (the “magic” chemical in magic mushrooms) under medical supervision pulled their legislation, reports KQED.

The bill’s authors cited a certain “no” vote in a coming Assembly Health Committee hearing as the reason for axing their own legislation.

This is the latest failure of legislation aimed at liberalizing laws surrounding psychedelic use in the Golden State.

Last year, Gov. Gavin Newsom vetoed legislation that would have decriminalized the personal possession and use of various plant-based psychedelics, saying he might support narrower legalization of these substances for therapeutic uses.

In May, a broader measure that would have established a statewide system for licensing and regulating psychedelic use, including the use of MDMA, mescaline, and psilocybin, in private therapeutic settings stalled in the state Senate.

The bill that failed this week was narrower still. It would have authorized the public health officers of San Francisco, San Diego, and Santa Cruz to license up to five facilities where licensed medical professionals could administer psilocybin and psilocin (both psychoactive substances found in so-called magic mushrooms) to screened military veterans and first responders. The program would sunset after three years.

California’s latest, failed reform efforts were modeled off new programs set up by Oregon and Colorado that likewise legalize psychedelic use in tightly regulated, state-licensed therapy-like settings.

Some local jurisdictions, including several California cities and Washington, D.C., have passed more modest “deprioritization” policies to classify enforcement of certain psychedelic laws as the lowest law enforcement priority.

In D.C., at least, that’s created a thriving gray-black market for psychedelic mushrooms. With the modest assurance that they won’t face legal penalties, many of the city’s pre-existing, semi-legal cannabis businesses have started selling mushrooms as well.

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Slow-release ketamine tablets help prevent depression relapses, UK trial finds

Slow-release ketamine pills have been found to prevent relapse into depression, in a trial that could pave the way for a new treatment option for patients with severe illness.

Ketamine is already used as a treatment for depression when conventional antidepressant drugs and therapy have failed. But ketamine is currently only administered intravenously, which requires supervision in a clinic, and the National Institute for Health and Care Excellence ruled that a ketamine-like nasal spray should not be available on the NHS.

If the apparent benefits are confirmed in a larger trial, ketamine tablets could be taken at home more cheaply, conveniently and potentially with fewer side-effects, the researchers said.

“We’re seeing a clinically meaningful effect,” said Prof Allan Young, of King’s College London and a co-author of findings. “This is not a definitive result, but the effect size is gratifyingly large.”

The phase 2 trial used an extended-release formulation of ketamine, designed to release the drug into the body over a 10-hour period. The hope was that this would make the treatment more effective and reduce adverse effects such as dissociation, high blood pressure, a racing heart or feelings of numbness. The “slow peak” would also reduce the drug’s abuse potential, Young said.

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Arizona’s Democratic Governor Vetoes Bill To Legalize Psilocybin Service Centers

The Democratic governor of Arizona has vetoed a bill to legalize psilocybin service centers where people could receive the psychedelic in a medically supervised setting.

Less than a week after lawmakers gave final approval to the legislation, Gov. Katie Hobbs (D) rejected it on Tuesday, arguing that while the psychedelic may hold therapeutic potential, “we do not yet have the evidence needed to support widespread clinical expansion.”

“Arizonans with depression and PTSD deserve access to treatments that may be seen as outside the mainstream, but they should not be the subject of experiments for unproven therapies with a lack of appropriate guardrails,” the governor said in a veto message.

She also said that the bill’s estimated cost is $400,000 per year, which wasn’t accounted for in the budget.

Under the now-vetoed legislation, the Department of Human Services (DHS) would have been authorized to license psilocybin-assisted therapy centers in the state, where trained facilitators could have administered the psychedelic.

The measure would have significantly expanded on Arizona’s existing research-focused psychedelics law that provides $5 million in annual funding to support studies into psilocybin therapy.

Hobbs cited that research funding in her statement, saying the goal is to “ensure that those who seek psilocybin treatment are doing so confidently and safely under proper supervision of qualified professionals with documented and verified research to support the treatment.”

She said that money “will be allowed to continue with this year’s budget,” with a separate funding bill she signed into law on Tuesday protecting those dollars, which are exempt from lapsing appropriations provisions.

The vetoed proposal, meanwhile, would have established an Arizona Psilocybin Advisory Board, comprised of members appointed by the governor and legislative leaders. Representatives of the attorney general’s office and DHS, as well as military veterans, first responders, scientists with experience with psilocybin and physicians would have been among the members.

The board would have been responsible for establishing training criteria for psilocybin service center staff, making recommendations on the implementation of the law, and studying the science and policy developments related to psychedelics.

Sen. T. J. Shope (R), the bill’s sponsor, told The Center Square that the veto is a “disappointing result after months of hard work and the overwhelming bipartisan support this received in both houses of the Legislature this year.”

The senator added that if lawmakers were still in session, he’d be pushing for a vote to override the veto, but he’ll have to “settle for trying again next year.”

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House Passes Veterans-Focused Marijuana And Psychedelics Amendments

The U.S. House of Representatives has approved amendments to a large-scale spending bill that would authorize U.S. Department of Veterans Affairs (VA) doctors to issue medical marijuana recommendations to military veterans and support psychedelics research and access.

One day after the Rules Committee cleared the proposals for floor consideration, the full chamber adopted them as part of appropriations legislation covering Military Construction, Veterans Affairs and Related Agencies (MilConVA) in a series of votes on Tuesday.

The cannabis measure passed in a vote of 290-116, while the two psychedelics proposals were adopted on voice votes.

One of the accepted proposals from Reps. Brian Mast (R-FL), Earl Blumenauer (D-OR), Barbara Lee (D-CA) and Dave Joyce (R-OH)—who together are the co-chairs of the Congressional Cannabis Caucus—would allow veterans to access state medical marijuana programs and eliminate a VA directive barring the department’s doctors from issuing cannabis recommendations.

SEC. 419. None of the funds appropriated or other wise made available to the Department of Veterans Affairs in this Act may be used to enforce Veterans Health Directive 1315 as it relates to—

(1) the policy stating that ‘‘VHA providers are prohibited from completing forms or registering Veterans for participation in a State-approved marijuana program’’;

(2) the directive for the ‘‘Deputy Under Secretary for Health for Operations and Management’’ to ensure that ‘‘medical facility Directors are aware that it is VHA policy for providers to assess Veteran use of marijuana but providers are prohibited from recommending, making referrals to or completing paperwork for Veteran participation in State marijuana programs’’; and

(3) the directive for the ‘‘VA Medical Facility Director’’ to ensure that ‘‘VA facility staff are aware of the following’’ ‘‘[t]he prohibition on recommending, making referrals to or completing forms and registering Veterans for participation in State approved marijuana programs’’.

“My proposed amendment, I believe, is common sense. It allows doctors in the VA—those that deal with veterans—to give advice to their veteran patients,” Mast said on the floor. “That seems simple enough, but under the status quo, VA doctors are limited in essential treatment options that they can offer to their patients and treatments that patients that are not veterans can readily assess in many states.”

“Beyond the veteran population, the nation is turning the page on how we think about cannabis. It’s become a key part of the medical system in more than 30 states. It offers law-abiding Americans a low-cost and safe option,” he said. “Do not keep those who’ve fought for our country from accessing what’s proven to be a critical tool for pain management. It is time for change. Veterans deserve to have access to every possible tool, and the best medical options available and the best possible medical advice by their doctors.”

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DEA Exemption Process For Religious Psychedelics Use Needs Clearer Timelines And Standards, Government Watchdog Agency Says

A federal government watchdog agency says in a new report that the Drug Enforcement Administration should improve the process through which it considers granting religious exemptions for psilocybin and other controlled substances, asserting that the existing route lacks clarity on timing, evaluation and other matters.

The 80-page report from the U.S. Government Accountability Office (GAO) notes that although psilocybin remains a Schedule I controlled substance under the Controlled Substances Act (CSA), people may petition DEA for exemptions to use it—or other controlled substances—for religious purposes.

“DEA has established a process for these petitions, but its guidance doesn’t set clear timeframes for the decision-making,” it continues. “Exemption petitions have taken from 8 months to over 3 years to be resolved.”

GAO focused specifically on psilocybin use under the Religious Freedom Restoration Act (RFRA), which is meant to protect religious practices from undue government burdens. The agency found that the DEA exemption procedure itself was burdensome.

“Selected stakeholders reported several barriers to the legal access and use of psilocybin for religious practices under the Religious Freedom Restoration Act,” GAO says. “For example, DEA established a process for parties to petition for a religious exemption from the Controlled Substances Act to use controlled substances for religious purposes. However, DEA’s guidance does not inform petitioners on its timeframes to make determinations on completed petitions.”

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Atlanta Could Add Psilocybin And Ketamine To City Workers’ Healthcare Plans Under Pending Resolution

A new proposal from an Atlanta City Council member would direct municipal officials to explore the pros and cons of adding coverage for psilocybin and ketamine as mental health treatments to the city’s healthcare plan for firefighters, police and other government workers.

“Traditional treatments for mental illnesses such as depression, anxiety, PTSD, and others have shown limited effectiveness for some individuals, leading to a need for exploring alternative therapeutic options,” the legislation, which is currently being sponsored by 11 of the Council’s 16 members, states. “Recent research has demonstrated the potential efficacy of alternative therapies such as ketamine-assisted therapy and psilocybin-assisted therapy in treating various mental health conditions, offering promising results where other treatments have failed.”

The resolution’s lead sponsor, Councilmember Liliana Bakhtiari, has said city workers deserve access to a broad range of mental health services.

“We should be offering our employees—and especially our first responders, who are expected to be superhuman—the same amount of grace and providing them with a tool set to essentially overcome this issue,” The lawmaker recently told Axios.

Bakhtiari said the impetus for including the drugs on public employees’ health plans was meeting a West Virginia police officer who witnessed a fellow officer die of suicide and later used ketamine to treat his PTSD. The lawmaker said they’re not aware of any other city governments that have looked into covering psilocybin or ketamine treatment.

The resolution from Bakhtiari would request the Atlanta’s human resources department to “explore the feasibility of adding coverage for ketamine therapy, psilocybin therapy, and other alternative therapies for mental illness in the City’s employee benefits contract during its next round of negotiations.”

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