Tag: psilocybin

Arizona Lawmakers Approve Psychedelics Bills To Create Psilocybin Advisory Board And Fund Ibogaine Research

Arizona lawmakers have approved two different bills focused on psychedelic therapy.

Senate passed a bill to create an advisory board tasked with studying the science of psilocybin, as well as state and federal policies surrounding the psychedelic, while the House separately approved a measure to fund clinical trials on ibogaine.

The Senate legislation from Sen. T. J. Shope (R) cleared the chamber in a 23-4 vote on Tuesday after it was significantly amended in committee, with members removing central provisions to establish licensed psilocybin service centers for adults seeking mental health treatment.

On the House side, the body advanced the ibogaine research legislation, sponsored by Rep. Justin Wilmeth (R), in a 36-22 vote on Monday, sending it to the Senate. It would provide funding for the state Department of Health Services (DHS) to “conduct a certified clinical research study on the use of ibogaine for the treatment of neurological diseases.”

An earlier version of Shope’s Senate psilocybin bill moved through both chambers last year with the regulated access components intact, but it was vetoed by the Democratic governor, who argued that “we do not yet have the evidence needed to support widespread clinical expansion.”

However, the year before, Gov. Katie Hobbs (D) signed into law budget legislation that included provisions to fund research into the medical potential of psilocybin mushrooms for a variety of conditions.

The new Senate-passed bill hopes to leverage some of those appropriated $5 million to create an Arizona Psilocybin Advisory Board, comprised of up to 12 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 be among the members.

Under the bill, the board would need to be selected by December 31, 2025, and they’d need to hold their first meeting by March 1, 2026.

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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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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 Mexico Bill Would Legalize Psilocybin Therapy In Supervised Medical Setting

Newly introduced bipartisan legislation in New Mexico would establish a therapeutic psilocybin program in the state, legalizing the active ingredient in psychedelic mushrooms for use in a supervised medical setting.

Under SB 219, titled the Medical Psilocybin Act, patients with certain qualifying conditions would be able access psilocybin and use it under the guidance of a licensed healthcare provider. Therapy would consist of a preparation session, an administration session and a follow-up integration session.

Text of the measure as introduced says the act’s purpose “is to allow the beneficial use of psilocybin in a regulated system for alleviating qualified medical conditions.”

Qualifying conditions under the bill include major treatment-resistant depression, PTSD, substance use disorders and end-of-life care, though the state Department of Health could approve additional conditions.

The state would also license psilocybin producers to grow mushrooms and process psilocybin. Synthetic psilocybin and synthetic analogs of the substance would not be allowed under the proposal.

The 18-page bill has five listed sponsors, including four Democrats and one Republican. It’s been referred to the Senate Tax, Business and Transportation Committee.

“The Medical Psilocybin Act creates a carefully designed framework for the Department of Health to establish a medical program for psilocybin use,” said lead sponsor Sen. Jeff Steinborn (D) in statement posted to social media. “Ensuring New Mexicans have access to every available treatment for serious behavioral health challenges is critical, and this proven therapy offers new hope for those in need.”

Republican sponsor Sen. Craig Brandt, meanwhile, said he’s “excited to be able to offer this breakthrough medical treatment to New Mexicans.”

“Medical psilocybin is proving to be effective in treating traumatic brain injuries, post-traumatic stress disorder (PTSD), depression, and other mental health conditions,” he said. “As a veteran I’m hopeful that this new medical option will provide help to my fellow veterans.”

The state health department would be responsible for establishing guidelines around training for clinicians and producers, including dosage, approved settings for administration, production and storage protocols and other best practices.

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Indiana Lawmakers File Bills To Legalize Marijuana And Fund Psilocybin Research In 2025

Indiana lawmakers are already making moves to enact drug policy reform in the 2025 session—with newly filed bills to legalize marijuana, allow medical cannabis and fund psilocybin research.

While the prospects of the cannabis measures are unclear given the Republican-controlled legislature’s historic resistance to reform, the psychedelics legislation would simply provide the necessary funding for an already-enacted law promoting psilocybin research.

Senate Bill 113

Sen. Rodney Pol (D) has introduced legislation that would legalize marijuana for recreational and medical purposes in the state.

The bill would establish a regulatory framework and excise tax for cannabis, while creating an Indiana Cannabis Commission (ICC) and Advisory Committee to oversee the program.

It would also facilitate research into marijuana and provide for the expungement of criminal records for offenses made legal under the reform.

According to a fiscal note from the Legislative Services Agency (LSA), enacting the bill would generate “between $46.6 million and $92.6 million in FY 2026 and $50.8 million and $101.7 million in FY 2027 from Sales and Excise Taxes and permit fees.”

Despite the GOP-controlled legislature’s history on marijuana policy reform, some suspect the tides might change in 2025. Part of that enthusiasm comes from the fact that Gov.-elect Mike Braun (R) recently said that “it’s probably time” to allow access to therapeutic cannabis.

However—despite a recent survey showing nearly 9 in 10 Indiana adults support legalizing medical marijuana—Republican leaders in the legislature are pushing back on the idea.

“It’s no secret that I am not for this,” Senate President Pro Tem Rodric Bray (R) said last month. “I don’t have people coming to me with really compelling medical cases as to why it’s so beneficial. And any state that I’ve seen pass medical marijuana is essentially passing recreational marijuana.”

House Speaker Todd Huston (R), meanwhile, doubted any medical benefits associated with marijuana, calling the substance “a deterrent to mental health.” He and others suggested that lawmakers supportive of the reform merely want to boost state revenue.

Meanwhile in Indiana, an organization led by the former head of the state’s Republican Party is pushing lawmakers to adopt what it’s calling “safe and regulated” policies on marijuana.

An interim study group had heard testimony around the possibility of decriminalizing simple cannabis possession last November, but the group did not make any specific recommendations.

House Bill 1332

The legislation, sponsored by Rep. Blake Johnson (D), would also establish a regulatory framework for adult-use marijuana, with a Cannabis Commission charged with overseeing the program.

Marijuana would be subject to a 10 percent excise tax, in addition to the state’s 7 percent sales tax.

“Revenue to the state General Fund is estimated to increase between $41.9 M and $82.1 M per year from Sales Taxes” on marijuana, according to a fiscal note. “Also, the bill establishes the nonreverting Cannabis Regulation Fund which could receive between $60.4 M and $118.5 M per year from the Cannabis Excise Tax and permit fee revenue.”

It would also impose new penalties for mislabeling hemp products and selling or transporting cannabis to minors.

House Bill 1145

Under a newly filed bill from Rep. Heath VanNatter (R), it would no longer be a crime to possess up to two ounces of cannabis or grow plants with more than two ounces.

The proposal would also increase the felony threshold for possession, raising it from 30 grams to four ounces.

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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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Psilocybin therapy offers relief from multiple psychiatric symptoms in cancer patients

New research published in Nature Mental Health indicates that psilocybin-assisted psychotherapy may offer comprehensive mental health benefits for individuals experiencing cancer-related distress. The study found that this treatment not only reduced symptoms of anxiety and depression but also reduced interpersonal sensitivity, hostility, obsession-compulsion, and somatization. These findings suggest that psilocybin could provide an innovative approach to addressing the profound psychological challenges associated with cancer.

Psilocybin-assisted psychotherapy is a relatively new approach that combines the administration of psilocybin, a psychedelic compound derived from certain mushrooms, with guided psychotherapy. Unlike traditional psychiatric medications, which are often taken daily and may take weeks to show effects, research suggests that psilocybin can produce rapid and lasting relief after just one or two carefully supervised sessions.

These sessions typically include preparation with a trained therapist, the psilocybin experience itself in a safe and supportive setting, and follow-up therapy to help process and integrate the experience. This method has shown promise in treating mood and anxiety disorders, particularly for patients facing existential challenges such as life-threatening illnesses.

For cancer patients, the psychological toll can be overwhelming, often manifesting as depression, anxiety, and emotional distress that significantly affect quality of life and clinical outcomes. Standard treatments, including therapy and antidepressant medications, frequently fall short in effectiveness and may be accompanied by delayed onset or undesirable side effects. Psilocybin-assisted psychotherapy offers a potential alternative, with rapid and sustained benefits.

While prior research has demonstrated psilocybin’s ability to reduce anxiety and depression in cancer patients, many individuals with cancer experience additional mental health symptoms, such as interpersonal sensitivity, hostility, somatization, and obsessive-compulsive tendencies. These symptoms exacerbate the emotional burden of cancer, yet their response to psilocybin-assisted psychotherapy had not been systematically investigated.

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Millions Of Americans With Depression Could Be Eligible For Psilocybin Therapy If Approved By FDA, Study Shows

As many as 6 in 10 people currently receiving treatment for depression in the U.S. could qualify for psilocybin-assisted therapy if the treatment were approved by the Food and Drug Administration. That’s according to a recent study in the journal Psychedelics that highlights the broad impact that could result from wider clinical availability of the entheogen.

“Our findings suggest that if the FDA gives the green light, psilocybin-assisted therapy has the potential to help millions of Americans who suffer from depression,” Syed Fayzan Rab, an MD candidate at Emory University, and the study’s lead author, said in statement about the report. “This underscores the importance of understanding the practical realities of rolling out this novel treatment on a large scale.”

The study, authored by a three-person team from Emory, the University of Wisconsin and UC Berkeley and published last month, sought to estimate the upper, midrange and lower boundaries of current depression patients—including both major depressive disorder (MDD) and treatment-resistant depression (TRD)—who would likely be eligible for the psychedelic treatment. Its low-end figure is 24 percent, the midrange estimate is 56 percent and the upper boundary is 62 percent of current patients.

Overall, the report gives a range of estimates on the number of depression patients who’d qualify for psilocybin therapy, with between 4.7 million and 6.6 million MDD patients and between 1.4 million and 1.9 million TRD patients potentially eligible.

“These ranges highlight the potential variability in our estimates based on changes in the assumptions underlying comorbidity prevalence, emphasizing both the robustness and the uncertainty inherent in our projections,” the paper says.

Behind the wide range of estimates are open questions about who would be eligible for psilocybin-assisted therapy (PSIL-AT). For example, authors said the variance was “largely influenced by the removal of alcohol and substance use disorders as exclusion criteria” as well as analysis of other comorbidities that may or may not affect patient eligibility.

Other issues involve the degree to which healthcare providers would dispense psilocybin for off-label use (meaning for conditions other than depression), whether treatment is covered by insurance and whether other psychedelics—for example LSD—become available as alternatives to psilocybin.

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Psilocybin May Curb Mental Illness That Leads to Eating Disorders

Psilocybin could help people suffering from a mental health problem that can lead to eating disorders, a new study suggests.

Psilocybin, the active chemical in “magic” mushrooms, significantly reduced symptoms in people with body dysmorphic disorder (BDD), researchers reported Sept. 24 in the journal Psychedelics.

BDD causes an obsessive preoccupation with perceived flaws in one’s physical appearance, and is frequently tied to eating disorders and other unhealthy behaviors, researchers said.

For this pilot trial, eight people with hard-to-treat BDD received a single 25-milligram dose of psilocybin.

Brain scans showed that the psilocybin treatment increased levels in connectivity between different brain regions related to emotional processing, cognitive activity and feelings and thoughts about oneself.

People who had the greatest strengthening in these connections experienced the most improvement in their BDD symptoms within a week, results show.

The findings “align with a growing body of evidence indicating that psychedelic compounds like psilocybin can promote mental health by enhancing the brain’s capacity for flexibility and integration,” concluded the research team led by Chen Zhang, a research assistant with the New York State Psychiatric Institute.

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