Tag: research

First Patient Dosed In Historic Study On Whether LSD Effectively Treats Anxiety

For the first time ever, researchers are administering LSD to patients in a Phase 3 clinical trial. The new study focuses on whether the psychedelic can be used to effectively treat generalized anxiety disorder (GAD).

Drugmaker MindMed says that the trial, dubbed Voyage, is eventually expected to enroll about 200 people in the U.S. and will compare the effects of its proprietary LSD product to a placebo. A second Phase 3 trial, called Panorama, will also be conducted in both the U.S. and Europe and is expected to kick off in the first half of next year.

“Today marks a pivotal moment in our journey towards advancing a novel treatment option for the 20 million people in the U.S. living with GAD,” MindMed’s chief medical officer, Daniel R. Karlin, said in a statement released on Monday. “Building on our scientifically rigorous Phase 2b study, which demonstrated efficacy that far exceeds today’s standard of care and a favorable tolerability profile, our Phase 3 studies are designed to adhere to the highest clinical and ethical standards and are in alignment with guidance from the U.S. Food and Drug Administration.”

In March of this year, the Food and Drug Administration (FDA) granted MindMed’s LSD product “breakthrough therapy” status as a treatment for GAD. That followed a Phase 2 trial showing that a single oral dose of LSD led to “clinically and statistically significant” reductions in anxiety scores 12 weeks after administration, with 65 percent of participants showing a clinical response and 48 percent in clinical remission following the treatment.

Breakthrough drug status is meant to recognize the therapeutic promise of an emerging substance or therapy as well as speed the research and development of treatments that fill an unmet need. MDMA and psilocybin have also previously been awarded the designation.

The new research will use dissolvable oral tablets of the drug, MM120 ODT, or lysergide D-tartrate, which MindMed describes as a “proprietary and pharmaceutically optimized form of LSD.”

The first Phase 3 study, Voyage, will last a year and consist of two parts: a 12-week randomized, double-blind, placebo-controlled study to see how LSD affects anxiety symptoms. That will be followed by a 40-week extension period, during which participants can access open-label treatment with the drug based on the severity of their anxiety symptoms.

LSD has a noticeable subjective effect on sensation and cognition, which means it’s likely participants will know whether they received the psychedelic or a non-psychoactive placebo.

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DEA Calls For Increased DMT Production In 2025 To Support Development Of FDA-Approved Psychedelic Drug

The Drug Enforcement Administration (DEA) is increasing the 2025 quota for the legal production of DMT in the U.S., saying it agrees with requests for the adjustment to “support legitimate research and scientific efforts” to develop a Food and Drug Administration- (FDA) approved drug based on the psychedelic.

In a notice set to be published in the Federal Register on Tuesday, DEA cited “additional quota applications and comments from DEA-registered manufacturers,” justifying the increase for the psychedelic compound.

DEA released initial quotas for the production of Schedule I and Schedule II controlled substances for research purposes in September. At the time, it called for an increase in the manufacturing of the psychedelics ibogaine, psilocybin and psilocyn, while continuing to maintain stable quotas for other substances such as marijuana, THC and MDMA.

But following a public comment period, it raised the production goal for DMT from 11,000 grams to 20,000 grams.

It’s not clear how close researchers are to developing a DMT-based drug, but several companies have indicated their intent to bring the psychedelic to market, pending regulatory approval.

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A Psychedelic Ban Would Disrupt Important Research

You have probably never heard of 2,5-dimethoxy-4-iodoamphetamine (DOI), much less worried about its possible abuse. Yet the Drug Enforcement Administration (DEA) wants to ban this synthetic psychedelic, a promising research chemical used in more than 900 published studies, by placing it in Schedule I of the Controlled Substances Act. Students for Sensible Drug Policy (SSDP), which defeated a previous DEA attempt to ban DOI in 2022, is determined to stop the agency’s interference with science again.

A DEA administrative law judge has scheduled a 10-day hearing on the proposed ban, beginning on November 12. SSDP, which filed a prehearing statement on behalf of more than 20 scientists, argues that placing DOI in Schedule I would impose “onerous financial and bureaucratic obstacles on researchers.” SSDP also opposes the scheduling of another psychedelic, 2,5-dimethoxy-4-chloroamphetamine (DOC), under the same proposed rule, which the DEA published last December.

“DOI and DOC are important research chemicals with basically no evidence of abuse,” says SSDP alum and legal counsel Brett Phelps. 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.”

SSDP describes the two compounds as “essential research chemicals in pre-clinical psychiatry and neurobiology,” noting that their unscheduled status has made them accessible as tools for studying serotonin receptors. It says DOI, in particular, has been “a cornerstone in neuroscience research” due to its selectivity for the 5-HT2A serotonin receptor, crucial for understanding the therapeutic effects of psychedelics. Scientists have used DOI to “map the localization of an important serotonin receptor in the brain critical in learning, memory, and psychiatric disease,” SSDP notes, and DOI studies “have shown encouraging results in managing pain and reducing opioid cravings.”

The DEA argues that DOI and DOC “have a high potential for abuse.” While the two compounds “are available for purchase from legitimate chemical synthesis companies,” the DEA concedes, “there is no evidence of diversion from these companies.” But it notes that both drugs “have been encountered by law enforcement in the United States,” indicating their “availability for abuse.” Because “DOI and DOC are not found in FDA-approved drug products,” the DEA says, people who use them must be doing so “on their own initiative, rather than based on medical advice.”

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DEA Calls To Increase Production of Psychedelics For Clinical Research

This week, the Drug Enforcement Administration (DEA) proposed increases to the production quotas of psilocybin, psilocin, and ibogaine for use by researchers investigating therapies with psychedelic compounds. The DEA oversees the regulated synthesis and cultivation of restricted psychoactive materials for scientific investigations.

A revised production agenda for 2024 calls for psilocybin and psilocin production to be increased by 50% – from 20,000 to 30,000 grams for psilocybin, and 24,000 to 36,000 grams for psilocin. These are the gram amounts planned for 2025 as well.

The DEA’s plans for 2025, posted as a notice in the Federal Register, includes the increased manufacturing of ibogaine from 150 to 210 grams. There is no change to the manufacturing level of other psychedelics such as MDMA or 5-MeO-DMT.

“This opens the door to more research, more clinical trials, and a better understanding of how we can apply emerging therapies,” says Representative Morgan Luttrell (R-TX). Luttrell is a former Navy SEAL whose therapeutic experiences with ibogaine and 5-MeO-DMT inform his advocacy for the government to fund psychedelic research, including allocations made in the fiscal 2024 National Defense Authorization Act. 

Expanding Research

The Controlled Substances Act, signed into law in 1970 by Richard Nixon, created five schedules under which to list drugs and allowed governmental regulation of how much of each drug could be produced for any purpose. Many psychedelics were placed under Schedule 1, the most limited schedule.

Researchers studying psychedelics in subsequent years faced scarce supplies of these substances, but their availability in recent years has grown significantly. In 2020 the DEA planned the production of just 30 grams of psilocybin; by 2024, the DEA increased the production to 20,000 grams.

The re-emergence of psychedelics as medicines is supported by expanding interest by researchers to study these compounds for their potential for effective treatments for mental health issues including depression, PTSD, and substance use disorder. Substances like psilocybin, psilocin and ibogaine are still listed in Schedule 1, which declares that they have no currently-accepted medical use. Researchers are investigating new treatments for mental health disorders through a variety of proposed mechanisms – such as by re-opening critical periods of learning or by collapsing default mode network activity in the brain. 

Despite promising areas of research to find new mental health treatments, DEA scheduling has been a major impediment into research on psychedelics, says Dalibor Sames, a professor of chemistry at Columbia University who studies iboga alkaloids. “While we have the DEA license, it is highly inefficient and cumbersome to share scheduled substances with collaborators,” he says. “Research in these days is highly collaborative and thus sharing compounds and other research items is an essential part of doing science and drug discovery today.”

By increasing their production quotas, DEA appears to be signaling their intent to support psychedelic research, stating in the revised 2024 notice: “These proposed increases demonstrate DEA’s support for research with schedule I controlled substances,” writes the agency. “The proposed increases reflect research and development needs as part of the process for seeking the FDA approval of new drug products.”

For researchers like Sames, who uses small amounts of iboga alkaloids in the study of psychedelic chemistry, the new quota has no immediate impact. But the increased availability of these three drugs could influence their availability for use in clinical trials with human subjects. 

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Google has funded EcoHealth’s virus research for at least 14 years

The 2018 paper, titled ‘Serologic and behavioural risk survey of workers with wildlife contact in China’, reported on a study conducted in Guangdong Province, China, which aimed to identify risky populations, occupations and behaviours that contribute to the transmission of zoonotic pathogens with pandemic potential.

It was authored by researchers from Yale University, Metabiota, EcoHealth Alliance, the Guangdong Provincial Centre for Disease Control and Prevention and the University of Washington Centre for One Health Research – one of them being Peter Daszak.

But, as Natural News wrote, check out the conflict of interest statement: “Metabiota Inc. is a commercial company that received funding from Google/Skoll.”

The Skoll Foundation was created in 1999 by Jeffrey Skoll, who made his fortune as eBay’s first full-time hire and president.

It turns out that Google.org, the charity arm of Google, has been funding studies carried out by EcoHealth Alliance researchers, including Peter Daszak, for at least 14 years.  A 2010 study on bat flaviviruses lists both Daszak and EcoHealth vice president Jonathan Epstein as authors – and like the 2018 study mentioned above, this 2010 study thanks Google for funding it.

Yet another paper on henipavirus spillover that was published in 2014 shows the same authors and funding from Google, demonstrating a lengthy relationship between these entities.

Natalie Winters – who first wrote about Google funding research conducted by Daszak’s EcoHealth Alliance in 2021 – posted a Twitter thread about it earlier this month to remind us.  Her thread also lists another paper published in 2015, tying Google to Daszak and EcoHealth.

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Researchers Ask Federal Court To Block DEA From Banning Two Psychedelics Under ‘Unconstitutional’ Administrative Process

Researchers are asking a federal court to block the Drug Enforcement Administration (DEA) from proceeding in its attempt to ban two psychedelics, arguing that the agency’s administrative approach to the proposed scheduling is unconstitutional.

Panacea Plant Sciences (PPS) filed a complaint and request for injunctive relief against DEA in the U.S. District Court for the Western District of Washington last week.

The legal challenge focuses on the agency’s recent scheduling of an administrative hearing to receive expert input on its controversial plans to classify 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) as Schedule I drugs under the Controlled Substances Act (CSA).

The filing doesn’t speak to the merits of the scheduling proposal—an issue that psychedelics researchers have previously addressed in public comment. Rather, PPS is contesting the administrative hearing process that’s preceding final rulemaking, arguing that DEA’s reliance on administrative law judges (ALJs) to settle such arbitration is unconstitutional based on U.S. Supreme Court precedent.

PPS said that because the Supreme Court has held that ALJs are considered “inferior officers,” current statutory removal protections unconstitutionally insulate them from executive control under Article II of the Constitution. That means DEA should not be permitted to subject researchers to an administrative hearing concerning the psychedelic scheduling proposal, the filing says.

“The hearing and scheduling poses a significant threat to the company,” it says. “PPS conducts research and development on medical technologies which include the use of DOI or DOC for development and as products themselves. Currently, DOI and DOC are not controlled.”

“Under the Controlled Substances Act (CSA) and its implementing regulations, PPS will be required to turn over to law enforcement or destroy our stock of DOI and DOC which means the rule-making acts as an effective taking of property,” the document says.

“As a result, when PPS received the hearing notice from DEA, it was faced with a stark choice: either default and lose automatically or defend itself against the DEA’s attempts to schedule DOI and DOC and its use of an ALJ-overseen adjudication,” it continues. “PPS is thus compelled to participate in the DEA’s adjudicatory proceedings.”

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‘Arbiter of Truth’ & ‘Disinformation Guru’ Tells Public ‘Don’t do Your Own Research’

During a recent discussion, Pennsylvania Secretary of the Commonwealth Al Schmidt and Executive Director of the Pitt Disinformation Lab Beth Schwanke spoke about beguiling the public into believing establishment sources.

The discussion specifically regarded what they deem as misinformation and disinformation on elections and how Americans should not have a mind of their own.

The Pitt Disinformation Lab executive lambasted self-led investigations, instead saying Pennsylvanians should just blindly eat up what the ‘trusted sources’ claim to be true. She also discussed January 6th and the 2020 election as a failure of control over the minds of citizens.

“One thing everyone can do to make sure they are seeing accurate information is to use trusted sources. So in elections that means using the Department of State, that means using your county elections office, it means using media organizations that follow, that adhere, to professional journalism standards like … your local NPR affiliate,” Schwanke said. “And it doesn’t mean you know, ‘doing your own research’ and just asking questions and sharing, you know, posts from – I don’t know, in my case, it’s Uncle Joe, right? It means being thoughtful about where your sources are coming from.”

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How generative AI will ruin science and academic research

I often come back to Neil Postman’s 1985 classic Amusing Ourselves to Death. It’s a penetrating analysis on the cognitive effects of media technology. His focus is mainly on how the format and mode of communication influences the character of content and how that content then trains us, but to a lesser extent also how the discourse and the “atmosphere” of the information exchange affects these issues.

This is almost forty years ago, and the disruptive medium under scrutiny is television. The entire approach seems almost quaint, the 80s in relation to the current period being a comparative golden age of critical thinking, complex exposition and conscious, creative citizens.

Still, the issues Postman emphasizes were already significant way back then. You can summarize his criticism with television’s format having complex, detrimental effects on the content and character of public discourse, as well as on the cognitive abilities of human beings, especially in terms of understanding complex issues and parse arguments and evidence with many layers and branching implications.

The basic issue on Postman’s view is that written exposition and complex oral tradition alike foster and prepare the human mind for the rigors of critical thinking and rational reflection. And to the contrary, that the entertainment media and discourses as exemplified by television in particular, geared towards short-term gratification and the communication of sensational experiences, have rather the opposite effect.

His examples are really glaring, even back then:

Contradiction, in short, requires that statements and events be perceived as interrelated aspects of a continuous and coherent context. Disappear the context, or fragment it, and contradiction disappears. This point is nowhere made more clear to me than in conferences with my younger students about their writing. “Look here,” I say. “In this paragraph you have said one thing. And in that you have said the opposite. Which is it to be?” They are polite, and wish to please, but they are as baffled by the question as I am by the response. “I know,” they will say, “but that is there and this is here.” The difference between us is that I assume “there” and “here,” “now” and “then,” one paragraph and the next to be connected, to be continuous, to be part of the same coherent world of thought. That is the way of typographic discourse, and typography is the universe I’m “coming from,” as they say. But they are coming from a different universe of discourse altogether: the “Now … this” world of television. The fundamental assumption of that world is not coherence but discontinuity. And in a world of discontinuities, contradiction is useless as a test of truth or merit, because contradiction does not exist. My point is that we are by now so thoroughly adjusted to the “Now … this” world of news—a world of fragments, where events stand alone, stripped of any connection to the past, or to the future, or to other events—that all assumptions of coherence have vanished. And so, perforce, has contradiction. In the context of no context, so to speak, it simply disappears. And in its absence, what possible interest could there be in a list of what the President says now and what he said then? It is merely a rehash of old news, and there is nothing interesting or entertaining in that.

– Postman, ibid.

This is not an unfamiliar situation for most of us. I even had a similar experience this morning in an attempted discussion with someone who incredibly enough stated four (!) different, mutually incompatible things within the framework of a couple of short paragraphs, and he of course still kept insisting I was wrong. His stated position contained the following propositions:

  1. Beliefs are absurd
  2. Beliefs ought to be held only due to acceptable evidence
  3. You can hold beliefs for whatever reasons you like
  4. Beliefs are by definition anchored in emotion and not acceptable evidence

All of these statements are literally incompatible with every single other one.

It’s like a convoluted version of the Liar’s Paradox. If I agree with him, I’m necessarily wrong, and if I disagree, I’m wrong too. But in contrast to the old thought experiment, where my error lies in the direct affirmation of a statement’s opposite, here there’s literally no way to make sense of how I would be wrong if I either agree with or reject his position, since it’s internally incoherent in a complex and not only binary sense.

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FLASHBACK: Air Force research: How to use social media to control people like drones

Facebook isn’t the only organization conducting research into how attitudes are affected by social media. The Department of Defense has invested millions of dollars over the past few years investigating social media, social networks, and how information spreads across them. While Facebook and Cornell University researchers manipulated what individuals saw in their social media streams, military-funded research—including projects funded by the Defense Advanced Research Projects Agency’s (DARPA) Social Media in Strategic Communications (SMISC) program—has looked primarily into how messages from influential members of social networks propagate.

One study, funded by the Air Force Research Laboratory (AFRL), has gone a step further. “A less investigated problem is once you’ve identified the network, how do you manipulate it toward an end,” said Warren Dixon, a Ph.D. in electrical and computer engineering and director of the University of Florida’s Nonlinear Controls and Robotics research group. Dixon was the principal investigator on an Air Force Research Laboratory-funded project, which published its findings in February in a paper entitled “Containment Control for a Social Network with State-Dependent Connectivity.”

The research demonstrates that the mathematical principles used to control groups of autonomous robots can be applied to social networks in order to control human behavior. If properly calibrated, the mathematical models developed by Dixon and his fellow researchers could be used to sway the opinion of social networks toward a desired set of behaviors—perhaps in concert with some of the social media “effects” cyber-weaponry developed by the NSA and its British counterpart, GCHQ.

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New Mexico Senate Committee Unanimously Approves Psilocybin Therapy And Research Resolution

A New Mexico Senate committee has unanimously approved a bipartisan resolution requesting that state officials research the therapeutic potential of psilocybin and explore the creation of a regulatory framework to provide access to the psychedelic.

The Senate Health and Public Affairs Committee voted 7-0 to pass the resolution from Senate Minority Whip Craig Brandt (R) and Sen. Jeff Steinborn (D) on Saturday.

As “memorial” legislation, the bicameral proposal wouldn’t be binding. Rather, it would represent a formal request for the state Department of Health to “study the efficacy of using psilocybin mushrooms for therapeutic treatments and the establishment of a program for psilocybin mushrooms to be used for therapeutic medical treatments.”

The whereas section of the resolution cites various studies supporting the therapeutic benefits of psilocybin for conditions such as major depression and substance misuse, while pointing out that the federal Food and Drug Administration (FDA) has designated the psychedelic as a “breakthrough therapy.”

To that end, the measure states that the health department should look into “necessary statutory or regulatory framework for developing” a state-level psilocybin program.

“This can help people very potentially, and so what we’re trying to do in a bipartisan way is ask the Department of Health to recognize that we want them to get going to start looking at this,” Steinborn said during Saturday’s committee hearing.

The measure “really seeks to expand therapeutic options for New Mexicans,” he said.

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