Tag: psychedelics

New York Bill Would Legalize Psychedelics Like Psilocybin, Mescaline And Ibogaine

Another psychedelics bill has been prefiled in New York for the 2025 session—this one calling for the legalization of certain entheogenic substances such as psilocybin and ibogaine for adults 21 and older.

Sponsored by Assemblymember Linda Rosenthal (D), along with eight cosponsors, the legislation would amend state statute to make legal the “possession, use, cultivation, production, creation, analysis, gifting, exchange, or sharing by or between natural persons of twenty-one years of age or older of a natural plant or fungus-based hallucinogen.”

DMT, ibogaine, mescaline, psilocybin and psilocyn would fall under the definition of “natural plant or fungus-based hallucinogens” that would be legalized by the bill.

Further, the legislation would authorize people to engage in psychedelic services “with or without remuneration,” as well as use the entheogens in religious ceremonies.

State and local law enforcement would be prohibited from cooperating or providing assistance to the federal government for the purpose of enforcing controlled substances laws against activities made legal under the state law.

The measure goes on to outline a series of protections: People couldn’t lose professional licenses, public assistance or be denied mental health or behavioral health services simply for using psychedelics. And their lawful use also couldn’t be the sole basis for a child welfare investigation.

New York localities wouldn’t be allowed to enact laws criminalizing psychedelics, but they could “adopt and implement legislation and policies which bear directly on or are related to natural plant or fungus-based hallucinogens in furtherance” of the bill.

Finally, the proposal would remove psilocybin, psilocyn, DMT, mescaline and ibogaine from the state’s banned substances list.

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The Day the Pope Met a Psychedelic Evangelist

The pope met an emissary from the psychedelic world at a “holy meeting” at the Vatican, where a Jesuit lawyer named Brian Muraresku presented Pope Francis with a manifesto for a psychedelic “New Reformation.”

Popes and reformations do not historically get along, but Francis accepted a copy of Muraresku’s 2020 book The Immortality Key at the meeting, which took place in late 2021 or early 2022. The book argues that psychedelics might rescue a “dying faith” and save Western civilization.

Though the science journalist Michael Pollan has called it “groundbreaking,” The Immortality Key is largely a rehash of others’ work shaped into a dubious Da Vinci Code–style thriller. Trade publishers would otherwise have little interest in a 400-page goose chase for what intoxicants the oracles and prophets might have been smoking or sipping, and so the book begins with a message for today. Western civilization, Muraresku argues, is in the grip of a cataclysmic “spiritual crisis” that can be remedied only through a “popular outbreak of mysticism,” the result of retrieving what he says are the Eucharist’s ancient, and until now secret, pharmacological roots.

And what are those roots? Muraresku is convinced that Christianity evolved from pagan mystery cults whose most sacred ritual involved the ingestion of a psychedelic fungus—and that this sacrament, the kykeon, eventually became the Holy Eucharist.

A protégé of Graham Hancock (an Economist reporter turned conspiracy theorist who has made a fortune writing speculative bestsellers about purported lost civilizations), Muraresku has written that “about seventy-five percent would leave the FDA-approved house church permanently transformed. And ready to begin a lifelong spiritual journey that could, once again, make life livable on this planet. This should begin happening by 2030, if not sooner.”

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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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JD Vance Asks Joe Rogan For Advice On Providing Psychedelics Access To Veterans After Being ‘Fascinated’ By Drug War History Lesson

Sen. JD Vance (R-OH), former President Donald Trump’s vice presidential running mate, says he’s “fascinated” by the therapeutic potential of psychedelics, asking podcaster Joe Rogan for advice on a creating a possible “pathway” for providing access to substances such as MDMA and psilocybin for military veterans with serious mental health conditions.

Vance told Rogan that his overall philosophy on marijuana and psychedelics is “live and let live,” and he reaffirmed that he feels people should not be criminalized over cannabis. The podcast host also gave the senator a history lesson on marijuana prohibition that Vance said he had “no idea” about.

While the candidate has previously discussed his position that states should have the right to set their own cannabis policies, this is the first time he’s publicly weighed in on laws around psychedelics, though he made clear he’s “not committing to some public policy” and needs to “be careful with this stuff, especially six days from an election.”

After Rogan described research on the medical value of psychedelics and the lack of access to such substances under the current federal drug scheduling statute—as well as the racially discriminatory history of marijuana prohibition—Vance said he “had never heard about” those particular points.

“I’m a veteran too. I spent four years in the Marine Corps—went to Iraq, went to Haiti once,” he said. “What is the pathway, I guess? Or what do you think should happen for veterans accessing psychedelics?”

Rogan told the senator “there are so many anecdotal stories about veterans experiencing relief that I think it should be available to them, especially veterans.”

Vance followed up, inquiring about whether psychedelics access would be incumbent on approval by the Food and Drug Administration (FDA).

“If it had a medical use, presumably, you would get it off of Schedule I [of the Controlled Substances Act (CSA)]. So why aren’t we—I’m just fascinated by this. This is the first time I’ve heard about this,” the senator said.

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DEA Seeks To Block Experts From Giving ‘Incompetent’ Testimony At Hearing On Proposed Psychedelics Ban

The Drug Enforcement Administration is seeking to block certain experts from testifying in an administrative hearing about the agency’s proposal to ban two psychedelic compounds that scientists say hold significant therapeutic potential.

Ahead of the 10-day hearing that a DEA administrative law judge (ALJ) scheduled for next month, the agency pushed back against the inclusion of multiple experts in the proceeding on the basis that the “proposed testimony and exhibits are incompetent, irrelevant, immaterial, and/or unduly repetitious.”

DEA further asserted that while the head of the agency can consider arguments on “barriers or hinderances to research” in the event that the psychedelics—2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC)—are placed in Schedule I of the Controlled Substances Act (CSA), allowing scientific experts to testify about the potential research harm without qualifying evidence “would result in a waste of judicial time and resources.”

“The Government argues that research harm evidence is not relevant to the issues and factors discussed above,” DEA said. That’s in spite of the fact that federal officials have repeatedly discussed the barriers to research associated with a drug’s placement in Schedule I.

Following a public comment period, DEA ALJ Paul Soeffing in August set an administrative hearing on the issue from November 12-22, with a final meeting on November 25, according to a recent notice that was shared with Marijuana Moment by the advocacy group Students for Sensible Drug Policy (SSDP).

On Thursday, SSDP filed a motion responding to DEA’s brief, saying that agency is “purporting much of the testimony and exhibits are incompetent, irrelevant, immaterial, and/or unduly repetitious despite the less rigid evidentiary rules that exist for administrative hearings where courts have repeatedly established that the [ALJ] has great deference in deciding what evidence may be permitted.”

“What is the DEA so scared of that these leading scientists must be muzzled?” Robert Rush, a Denver-based attorney who is working with SSDP on the DOI and DOC case, said in a press release.

“By trying to silence the world’s leading experts in neuroscience and pharmacology, the DEA is attempting to prevent the tribunal—and the public—from understanding the true potential of these substances,” he said. “We vigorously oppose the DEA’s efforts to stop scientific research and call on the tribunal to reject the Government’s motion and ensure that all relevant evidence is heard.”

This all comes as DEA separately scheduled a December hearing to gain additional input on the Biden administration’s marijuana rescheduling proposal—a move that will delay that reform from potentially taking effect until after the presidential election.

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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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