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Tag: psychedelics
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.”
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.
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.
Could Psychedelics Transform How Doctors Treat Chronic Pain?
Doctors across the country are beginning to look beyond their prescription pads to explore new treatments for chronic pain management: psychedelics.
As clinical research mounts, patient stories become more frequent, and a desperate call for new solutions to help people find relief for chronic pain becomes louder, substances like psilocybin and MDMA are entering medical education as promising new treatments.
Healthcare professionals are listening and learning how psychedelics could become part of their practices, offering new hope to patients for whom traditional methods – like opioids and nerve blocks – often fall short.
Recently at the annual PAINWeek conference, more than 1,400 pain management professionals gathered to learn about advances in the field. Psychedelics took center stage: the 2024 event marked the first time psychedelic medicines had a dedicated track on the agenda.
Retired FDNY firefighter Joe McKay and advocate Court Wing shared their experiences with using psychedelics to combat their chronic pain conditions.
Presentations in the psychedelic track were delivered by patients, healthcare professionals, including Dr. Eugene Vortsman, licensed clinical social worker Erica Siegal, and attorney Deborah Linden Saly, who are each engaged in research, advocacy, or clinical practice with substances like psilocybin, MDMA, LSD, and DMT.
A growing body of evidence shows people living with conditions including chronic low back pain, migraine, cluster headaches, fibromyalgia, traumatic brain injuries, and phantom limb pain often find that existing treatments are either ineffective or come with troubling or dangerous side effects.
The presence and fervor around psychedelics at the conference is the latest example of a growing focus by the medical community on psychedelics as a new and promising treatment for a wide range of chronic pain and physical conditions.
Psychedelic mushrooms may have played a role in development of human consciousness, study finds
Psychedelic fungi containing psilocybin may have played a role in the development of human consciousness a scientific review has suggested.
The study, published in the journal LILLOA, analysed multiple studies involving psilocybin, psilocin and human consciousness. Taking a multidisciplinary approach spanning studies from the fields of biology, ethnobotany, and neuroscience researchers found that psychedelic mushrooms, specifically the Psilocybe genus of the Hymenogastraceae family, had the “potential to trigger significant neurological and psychological effects” in humans.
The findings support the Stoned Ape Theory, a hypothesis proposed by ethnobotanist Terence McKenna in his 1992 book Food of the Gods. McKenna suggested that psychedelic mushrooms were the major evolutionary catalyst behind the rapid expansion of human consciousness.
“At the cerebral level, psilocybin affects various areas, such as the prefrontal cortex, the hippocampus, and the anterior cingulate cortex,” the study authors wrote. “The hypothesis that psilocybin mushrooms may have intervened as a factor in the evolution of human consciousness, either as catalysts for mystical experiences or as drivers of cognitive processes, raises profound reflections on the ancestral interaction between humans and their environment.”
The paper highlights how numerous ancient cultures across the world discovered and studied psilocybin-containing mushrooms, citing a prehistoric cave drawing of a shaman figure clutching mushrooms found in the Tassili caves in the Altas Mountains. This suggests, the authors said, that psychedelic mushrooms have played an important part in the evolutionary process of humans.
Federal Officials Say Psychedelic-Assisted Therapy Shows Promise For PTSD, But More Research Is Needed
Representatives of a number of federal agencies convened last week to discuss new treatments for PTSD, including therapies involving psychedelics, MDMA, ketamine and other drugs. While the officials acknowledged the substances’ potential to help treat PTSD and underlying symptoms, they also emphasized the need for further research to ensure efficacy and patient safety.
The discussion, hosted by the Reagan-Udall Foundation for the Food and Drug Administration, a nonprofit formed by Congress to support FDA, didn’t focus specifically on psychedelic-assisted therapies, but the topic nevertheless featured prominently—especially during a stakeholder comment session where most spoke in favor of wider access to MDMA and other emerging treatments.
Betty Aldworth, director of communications and post-prohibition strategy for the Multidisciplinary Association for Psychedelic Studies (MAPS)—which has helped lead the push to qualify MDMA as a federally approved treatment for PTSD—said the meeting “illustrated the growing public interest in psychedelic-assisted therapies, with nearly every speaker discussing their potential in a meeting that wasn’t specifically about psychedelics.”
“Eighty members of Congress, the Veterans Affairs Administration, trauma experts, patient advocates, and 14 of 23 stakeholder who gave oral testimony agree the existing evidence base for psychedelic-assisted therapies merit widespread, and growing, support,” Aldworth said in a statement after the event. “It’s time to close the 25-year gap on new pharmacotherapies for the treatment of PTSD by approving this most promising treatment for PTSD and bringing psychedelic-assisted therapies into the healthcare system.”
Speakers at the Reagan-Udall event on Friday included representatives from the Department of Defense, Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and Department of Veterans Affairs (VA).
Psychedelics Have ‘Demonstrated Potential For Treating Drug Addiction’ And Alcoholism, New Research Shows
Two new studies on psychedelics and alcoholism—including one with contributions from a top federal drug official—offer hope for new ways to treat alcohol use disorder (AUD).
One says a single dose of psilocybin “was safe and effective in reducing alcohol consumption in AUD patients,” while the other concludes that classic psychedelics like psilocybin and LSD “have demonstrated potential for treating drug addiction, especially AUD.”
The first study looked at 10 treatment-seeking adults “with severe AUD,” according to a preprint version of the research published online at Research Square. After a single 25 milligram dose of psilocybin, “alcohol consumption significantly decreased” during a 12-week period, the team found.
Coauthored by National Institute on Drug Abuse (NIDA) Director Nora Volkow—in her role at the National Institute on Alcohol Abuse and Alcoholism’s neuroimaging laboratory—along with 10 researchers at the University of Copenhagen, in Denmark, the open-label study found that most participants craved alcohol less and consumed fewer drinks following treatment with psilocybin.
“Participants reported a decrease from baseline to week 1 in alcohol craving,” the paper says—a decrease that was sustained four weeks and 12 weeks after the psychedelic was administered. “Further, participants reported an immediate change from baseline to week 1 in self-efficacy, i.e. confidence in the ability to abstain from alcohol.”
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