Tag: psychedelics

Psychedelics Have ‘Promising Medical Applications,’ Congressional Watchdog Agency Says, But Research Challenges Remain

A federal agency has published a short report on the medical use of psychedelics, finding that their ability to “change a person’s perceptions and sense of self” can make for “promising medical applications.”

The paper, from the Government Accountability Office (GAO), says there’s a need for further research, but it also notes that because psychedelics such as LSD, MDMA and psilocybin remain Schedule I controlled substances, securing permission to carry out that research can be a challenge.

“To conduct research on these drugs, scientists need to follow several steps,” the report from GAO, which is often referred to as Congress’s “watchdog,” states in a section about ongoing challenges. “These include obtaining permission from the U.S. Drug Enforcement Administration, finding clinical grade drugs to test, and identifying appropriate spaces in which to test and store these drugs.”

“Difficulties associated with conducting large, blind trials of psychedelics have limited researchers’ ability to determine the safety and effectiveness of these drugs,” GAO continues, “which is required for them to gain approval from the Food and Drug Administration (FDA). FDA approval is generally required before prescription drugs can be marketed for sale in the U.S.”

Despite the obstacles, the paper acknowledges that hundreds of clinical trials have investigated psychedelics as a potential treatment for post-traumatic stress disorder (PTSD) and depression.

“Between 2015 and early 2025, over 340 trials on psychedelics began or were completed,” it says. “For example, one study found that psilocybin reduced depression symptoms more than escitalopram, an SSRI.”

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U.S. Embassy Warns Americans Not To Use Traditional Psychedelics In Peru, Including Ayahuasca

The U.S. embassy in Lima, Peru, is warning Americans against a traditional psychedelic known as ayahuasca, cautioning that the mixture “is a psychoactive substance containing dimethyltryptamine (DMT), a strong hallucinogen that is illegal in the United States and many other countries.”

Officials argued that using ayahuasca or kambo—a psychoactive substance derived from some frogs—can cause negative health effects and increase risks of sexual assault, robbery and other hazards.

“These dangerous substances are often marketed to travelers in Peru as ‘ceremonial’ or ‘spiritual cleansers,’” embassy officials wrote in a late January health alert to U.S. citizens, adding: “Facilities or groups offering ayahuasca/kambo are not regulated by the Peruvian government and may not follow health and safety laws or practices.”

As for ayahuasca—a mixture of botanical ingredients that contains DMT—the alert says the substance “can cause several negative health effects, including nausea, vomiting, increased heart rate, and even death.  Some of the long-term effects include psychosis, difficulty sleeping, neurological diseases, and ongoing hallucinations.”

“In 2024, several U.S. citizens died or experienced severe illness, including mental health episodes, following consumption of ayahuasca,” it continues. “These incidents often occur in remote areas near or within the Peruvian Amazon, far away from modern medical facilities. The limited connectivity and limited access to emergency services and hospitals increases the risks.”

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Military Veterans Groups Push Congress To Expedite Psychedelics Research And Support Medical Marijuana Access

The U.S. Department of Veterans Affairs (VA) should continue to explore psychedelics and medical marijuana therapy and expedite access to such alternative treatments if they’re proven to be efficacious, representatives of leading veterans service organizations (VSOs) told members of Congress this week.

One key group testified that the scheduling of substances like cannabis, psilocybin and MDMA as Schedule I drugs is a “major barrier” to therapeutic access.

At joint hearings before the House and Senate Veterans’ Affairs Committees on Tuesday and Wednesday, lawmakers took testimony from the VSOs—and one theme that emerged was the need to support research and access for marijuana and psychedelics, particularly as it concerns VA.

Rep. Jack Bergman (R-MI), co-chair of the Congressional Psychedelics Advancing Therapies (PATH) Caucus, asked Disabled American Veterans (DAV) National Commander Daniel Contreras what role he felt VA should play in “advancing the promising field in that area of [psychedelic] medicine through research.”

Contreras said it’s DAV’s position that “we should look at alternatives.” He added that he’s personally familiar with the issue in part because psilocybin has been incorporated into his own wife’s therapy, which underscores for him that “there needs to be some alternative choices.”

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Missouri Lawmakers Consider Psychedelic-Assisted Therapy To Aid Military Veterans With PTSD

In hopes of helping veterans facing mental health issues, Missouri lawmakers are once again pushing legislation that would require the state to conduct a study on using psilocybin—also known as “magic mushrooms”—to treat depression, substance use or as part end-of-life care.

Similar legislation has been filed for the last three years, and in 2023 the House voted overwhelmingly in support of the idea. But it’s never made its way to the Senate.

On Monday, several members of the House Veterans Committee said they were staunchly against the proposal when they first heard about it. However, research the committee has explored over the years has changed their minds.

That includes studies done by psychiatry researchers at Washington University School of Medicine in St. Louis, who were the first in Missouri to give a legal dose of psilocybin in 2019.

They have been using a brain-imaging technique to learn how psilocybin affects certain networks in the brain.

The bill’s sponsor, Republican state Rep. Richard West of Wentzville, said he was skeptical at first, as a former police officer.

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Psychedelic use linked to reduced distress, increased social engagement in autistic adults

A recent study has found that some autistic adults report lasting improvements in their mental health and social lives after using psychedelic drugs. The research, published in the journal Psychopharmacology, revealed that a significant number of autistic individuals attributed reductions in distress and social anxiety, along with increased social engagement, to a single, impactful psychedelic experience. However, the study also highlighted that a minority of participants experienced negative effects, emphasizing the need for caution and further research in this area.

There is a growing interest in the potential of psychedelic drugs to treat various mental health conditions, such as depression and post-traumatic stress disorder, in the general population. Autism spectrum disorder, a developmental condition characterized by challenges in social interaction and communication, as well as repetitive behaviors, often co-occurs with mental health difficulties. Autistic individuals are known to experience higher rates of anxiety, depression, and loneliness, and often report a lower quality of life compared to non-autistic people.

While psychedelics are being explored as therapies for mental health in broader populations, there is very little scientific understanding of how these substances affect autistic individuals specifically. Some anecdotal accounts suggested that psychedelics might be helpful for autistic people, potentially by improving their understanding of themselves and their emotions, but rigorous research was lacking. The new study aimed to investigate the experiences of autistic adults who have used psychedelics and to understand if they perceived any changes in their mental health and social abilities as a result.

To conduct their investigation, the researchers used an online survey to gather information from adults who identified as autistic. Participants were recruited through advertisements on social media platforms, online forums related to psychedelics and autism, and by collaborating with an organization called the Autistic Psychedelic Community. The advertisements were carefully worded to encourage participation from individuals with both positive and negative psychedelic experiences. To be included in the study, participants had to be at least 18 years old, fluent in English, and either have a formal diagnosis of autism from a healthcare professional or self-identify as autistic. They also needed to have used a psychedelic substance at least once in their lives.

A total of 284 people completed the survey. For their analysis, the researchers focused on 233 participants who reported that their most ‘impactful’ psychedelic experience involved a classic psychedelic drug, such as lysergic acid diethylamide (LSD) or psilocybin (the active compound in magic mushrooms). The other participants who were excluded from the main analysis had reported that their most impactful experience was with substances like MDMA, cannabis, or ketamine.

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Federal Court Rejects Washington Doctor’s Effort To Legally Access Psilocybin For End-Of-Life Patient Care

A federal appellate court has rejected the latest effort by a Washington State doctor who is seeking to legally use psilocybin to treat cancer patients in end-of-life care, ruling that the Drug Enforcement Administration (DEA) provided a reasonable explanation in denying the doctor’s request.

In an opinion filed on Thursday, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit rejected arguments from lawyers for Dr. Sunil Aggarwal and his clinic, the Advanced Integrated Medical Science (AIMS) Institute that DEA’s denial of Aggarwal’s efforts was arbitrary and capricious

“DEA’s decision to deny AIMS’s request was neither arbitrary nor capricious,” the court concluded. “We therefore deny AIMS’s petition for review of the DEA’s decision.”

Aggarwal and AIMS have been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care, initially seeking to win permission from regulators under state and federal right-to-try laws.

When DEA rebuffed that request, Aggarwal sued. In early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.

The latest Ninth Circuit ruling results from Aggarwal’s responses to that ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA)—the denial of which is a reviewable action. He also applied for a regulatory waiver to obtain psilocybin.

DEA denied Aggarwal’s petition in September 2022 and rejected the waiver request the next month. The doctor’s Ninth Circuit case challenged both decisions.

“Following the dismissal of its earlier petition, AIMS returned to DEA with a concrete request. AIMS asked EA to exempt Dr. Aggarwal from registration under the CSA, either by finding that Dr. Aggarwal’s proposed use of psilocybin was not covered by the CSA’s registration requirement or by waiving the registration requirement,” Judge Marsha Berzon, a Clinton appointee, wrote for the court in Thursday’s opinion. “DEA declined to take action, and AIMS again petitioned for review. Because DEA’s response was neither arbitrary nor capricious, we deny AIMS’s petition for review.”

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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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