Tag: psilocybin

Missouri GOP Lawmakers File Bills To Legalize Psilocybin Therapy And Fund Clinical Trials For 2024 Session

Missouri Republican lawmakers have pre-filed a pair of bills to legalize the medical use of psilocybin and require clinical trials exploring the therapeutic potential of the psychedelic.

Sen. Holly Thompson Rehder (R) and Rep. Aaron McMullen (R) introduced similar versions of the legislation for the 2024 session, setting the stage for further consideration of psychedelics reform in the Show-Me State.

Under both proposals, adults 21 or older who are diagnosed with a qualifying condition such as post-traumatic stress disorder (PTSD) or substance misuse disorder could legally access laboratory-tested psilocybin. They also would need to be enrolled, or sought enrollment, in a Department of Health and Senior Services (DHSS) clinical trial involving the psychedelic.

The Senate version mirrors a separate House bill that advanced to the floor this year but was not ultimately enacted.

There are also numerous requirements for patients to provide DHSS with information about their diagnosis, the person who would be administering psilocybin and other details on the place and time of the treatment sessions.

Psilocybin could only be administered over a maximum of a one-year period, with the amount of the psychedelic used in that treatment capped at 150 milligrams, though qualifying patients could be also approved to continue for subsequent one-year periods.

Regulators, physicians and state agency officials would all be protected from legal consequences related to activity made lawful under the legislation.

Also, the legislation calls for DHSS to provide $2 million in grants to support “research on the use and efficacy of psilocybin.”

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LSD And Psilocybin Could Be Powerful Treatments For Pain—Without Opioids’ Dwindling Effects Over Time, Study Says

LSD and psilocybin could offer promising therapeutic potential for the treatment of chronic pain “on a mechanistic and experiential level,” according to a newly published literature review that highlights scientific findings happening as part of the “psychedelic renaissance”—a recent thawing of stigma and opposition into psychedelics research after decades of prohibition.

What’s more, authors note, the pain-relieving effects of LSD and psilocybin seem to increase with repeated treatment, unlike opioids, which display “decreased therapeutic effect” over time.

The narrative review, published last month in the South African Medical Journal, charts both the history of the two substances as well as scientists’ emerging understanding of their methods of action. It notes that the drugs seem not just to reduce pain but also better manage the experience of pain.

“Recent neuroimaging studies combined with small sample interventions with classic psychedelic agents,” authors wrote, “may point towards a possible means of improving the treatment of chronic pain on a mechanistic and experiential level.”

Classic psychedelics, the literature review explains, are those that bind to the central nervous system’s 5-HT2A receptors. They include both LSD and psilocybin.

The way psilocybin binds to receptors in the central nervous system “has similar effects to LSD on cognition, emotional processing, self-awareness and the perception of pain,” says the literature review, “which underpins its potential therapeutic benefit in treating people suffering with pain. Numerous small trials of LSD and psilocybin for chronic pain have already shown a good safety profile, with minimal physical dependence, withdrawal syndrome, or compulsive drug seeking compared with other analgesic agents.”

While the two drugs are part of the same family of alkaloids, their history is, of course, much different. The review describes explains that LSD was first synthesized in 1938, meaning humans have used it for less than a century. Psilocybin’s use stretches back thousands of years. In the modern U.S., psilocybin use was popularized in the late 1950s, while LSD grew to prominence in the ’60s and ’70s.

While there have been no reports of direct mortality from either substance and no withdrawal following chronic use, the study says, “the use of psilocybin in clinical research ended at the same time as LSD research as the Controlled Substances Act was enforced.”

Associations with counterculture and anti-government sentiment meant LSD and psilocybin research was abandoned, authors wrote. “From 1977 until the early 2000s, no more LSD research was published, despite overwhelming evidence pointing towards therapeutic benefit.”

Prior research had indicated LSD might be useful in treating depression, pain, and physical suffering in cancer patients and others. Among seven patients with phantom limb pain, participants treated with LSD reduced their analgesic requirements, and two patients’ pain was resolved.

During what the review refers to as the modern “psychedelic renaissance” or “the new wave of psychedelic research,” studies have found that psilocybin or LSD may help reduce cluster headaches, end-of-life depression in cancer patients and chronic pain.

In a pain study, a small sample of patients who self-medicate with the psychedelics “revealed a decrease in the experience of pain during the psychedelic session and for up to 5 days after treatment, before their pain returned to baseline.”

“The most exciting revelation from these interviews relates to the lasting psychological and emotional effect the psychedelics had on those interviewed,” the review says. “They describe increased resilience, body-self-awareness and psychological flexibility and psychological flexibility, which led to feelings of acceptance, agency and hope.”

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House And Senate Reach Deal To Require Psychedelics Clinical Trials For Active Duty Military Service Members Under Defense Bill

Bipartisan and bicameral congressional lawmakers have reached an agreement on a large-scale defense bill that contains a House GOP-led section to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members.

Following negotiations, lawmakers released the conference report for the 2024 National Defense Authorization Act (NDAA) on Wednesday evening, maintaining psychedelics research provisions championed by Rep. Morgan Luttrell (R-TX) that were attached to the House version over the summer. The report notes, however, that the House negotiators receded on a separate section to create a medical cannabis pilot program for veterans.

The psychedelics provisions that have been adopted would require the Department of Defense (DOD) to establish a process by which service members with post-traumatic stress disorder (PTSD) or traumatic brain injury could participate in clinical trials involving psilocybin, MDMA, ibogaine and 5-MeO-DMT. The list of covered psychedelics was also expanded to broadly include “qualified plant-based alternative therapies.”

DOD would need to facilitate that process within 180 days of enactment. It could partner with eligible federal or state government agencies, as well as academic institutions to carry out the clinical trials, with $10 million in funding.

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Psilocybin’s ‘Efficacy And Safety’ For Bipolar II Depression Demonstrated By American Medical Association Study

Results of a new clinical trial published by the American Medical Association “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder, a mental health condition often associated with debilitating and difficult-to-treat depressive episodes.

“The 15 participants in this trial had well-documented treatment-resistant BDII depression of marked severity and a lengthy duration of the current depressive episode,” authors wrote. After seven psychotherapy sessions, one involving a single dose of psilocybin, the paper says, study subjects “displayed strong and persistent antidepressant effects, with no signal of worsening mood instability or increased suicidality.”

In the nonrandomized controlled study, which was conducted at Sheppard Pratt Hospital in Baltimore, “12 patients met both response and remission criteria” at the end of a 12-week study period, the trial found, meaning that measures of the diagnosis had dropped by more than half and fell below a minimum threshold.

“The findings in this open-label nonrandomized controlled trial suggest efficacy and safety of psilocybin with psychotherapy in BDII depression.”

Patients’ self-reported quality of life scores “demonstrated similar improvements,” the study, which was funded by the biotechnology company COMPASS Pathways that develops psychedelic treatments, found. In terms of safety, metrics of suicidal ideation and mania “did not change significantly at posttreatment compared to baseline.”

The nine-author study, published on Wednesday in the journal JAMA Psychiatry, involved administering a single, 25-milligram dose of psilocybin. Patients with bipolar II disorder (BDII) met with therapists seven times—during three pre-treatment sessions, once during an “8-hour dosing day” and at three post-treatment integration sessions.

“In this study, most participants remitted rapidly (ie, within 1 week of dosing), and in most participants, remission persisted for the 12-week study duration,” the report says. “The 3 participants who restarted medication due to lack of benefit or relapse following improvement generally had poorer response throughout the trial.”

“In a sample of patients with treatment-resistant cyclical mood disorder, achieving persistent remission over a 3-month period is notable, especially given the single dosing of psilocybin,” it continues. “Further follow-up is warranted.”

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Top Federal Health Official Says Abstinence-Only Drug Treatment Is ‘Magical’ Thinking That ‘Costs A Lot Of Lives’

A top federal health official is offering some pointed critiques of the U.S. drug criminalization model, stressing how politicizing addiction has fostered a system of incarceration that increases overdose risk while biasing research that could reveal the benefits, as well as the risks, of substances such as marijuana and psilocybin. She also rebuked treatment approaches that focus exclusively on abstinence.

National Institute on Drug Abuse (NIDA) Director Nora Volkow made the comments in an appearance last month at the International Drug Policy Reform Conference, speaking on a panel with Drug Policy Alliance (DPA) Executive Director Kassandra Frederique.

One of the conversation points touched on the dangers of focusing on abstinence in drug treatment, rather than meeting people who use drugs where they’re at. The “inflexibility” of abstinence-only “costs a lot of lives,” Volkow said.

If a person wants to get treatment and abstain from drugs, “that’s great” as a “theoretical ideal,” the official said. “But to basically impose that as a reality for everyone—who have very different backgrounds and opportunities—I think it’s sort of like a magical thought and not practical.”

In general, the policies and strategies the U.S. has historically pursued to combat drug misuse are “not helping to address the overdose crisis,” evidenced by the fact that “overdose fatalities are continuing to rise,” Volkow argued.

“What it tells us is whatever we’re doing is clearly not sufficient. What do we need to do to change this?” she said at the panel, a recording of which was shared with Marijuana Moment. “This very polarized categorical perspective that it’s either, ‘you go abstinent or we don’t pay any attention to you and we send you to jail’ is catastrophic. I mean, it has basically contributed to what we’re seeing as a horrific problem in our country with horrible fatalities like we’ve never seen.”

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Health Benefits Provider Will Cover Psilocybin-Assisted Therapy In States Where It’s Legal

A Massachusetts company that bills itself as “the first and only licensed provider of psychedelic health plans” announced on Tuesday that it will cover psilocybin-assisted therapy in states where it’s legal.

“Given the evidence of effectiveness seen in clinical trials in the U.S. and elsewhere, we have decided to give our employers the option of including psilocybin-assisted therapy in their benefit plans,” said Sherry Rais, CEO and co-founder of Enthea, a third-party health insurance benefits administrator. “Oregon and Colorado have already legalized the use of psilocybin, and we expect others to do so next year.”

Enthea announced earlier this year that it would cover ketamine treatment nationwide. The nonprofit previously worked with soap company Dr. Bronner’s last year to offer psychedelic-assisted therapy to workers through their employee health plans.

Enthea said this week that it plans to expand its standards of care to include adult use of psilocybin “in combination with psychotherapeutic support.” The company expects to publish the change to its provider network sometime in the first quarter of next year.

The goal, Enthea said, is to be able to cover psilocybin-assisted treatment by mid-2024.

“We have had our eye on the potential benefits of psilocybin therapy since we founded our company,” Dan Rome, Enthea’s co-founder and chief medical officer, said in a press release. “We are very encouraged by published results as well as what we hear from practicing therapists, and are confident that this brings an important new option for combating mental illness.”

Enthea has said its services will expand further to include therapies with other substances, such as MDMA, “as they are approved.”

The Food and Drug Administration (FDA) designated MDMA as a “breakthrough therapy” in 2017, and the substance is now on track for FDA consideration next year following successful Phase 3 clinical trials published in September in the journal Nature that found that MDMA-facilitated talk therapy reduced symptoms in patients with moderate to severe PTSD.

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Bipartisan Wisconsin Lawmakers File Bill To Create Psilocybin Research Pilot Program For Military Veterans With PTSD

As marijuana reform continues to stagnate in the Wisconsin legislature, bipartisan and bicameral lawmakers have come together to introduce a new bill that would create a psilocybin research pilot program in the state.

Sens. Jesse James (R) and Dianne Hesselbein (D), as well as Reps. Nate Gustafson (R) and Clinton Anderson (D), are sponsoring the legislation, which would focus on exploring the therapeutic potential of the psychedelic in the treatment of post-traumatic stress disorder (PTSD) among veterans.

The pilot program would be facilitated through the University of Wisconsin at Madison, which already operates a multidisciplinary psychedelics research division that launched in 2021.

Veterans who are 21 and older with diagnosed treatment-resistant PTSD would be eligible to participate in the program. Psilocybin would need to be provided through existing pathways under the federal Food and Drug Administration (FDA), which has designated the psychedelic as a “breakthrough therapy.”

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House Committee Will Consider Protecting State Medical Psilocybin Laws From Federal Interference Under New Amendment

A pair of Democratic congressmen have filed an amendment to a large-scale spending bill that would prohibit the use of federal funds to interfere with state and local laws allowing the use and sale of psilocybin for medical purposes.

Reps. Robert Garcia (D-CA) and Earl Blumenauer (D-OR) are seeking to attach the psychedelics measure to appropriations legislation covering Commerce, Justice, Science, and Related Agencies (CJS). It will be up to the House Rules Committee to determine whether the amendment will be made in order for a floor vote.

The members separately introduced standalone legislation in September to prevent federal interference in any jurisdiction that legalizes the psychedelic.

The new CJS amendment, meanwhile, states that no appropriated funds under the spending bill “may be used to prevent any State, the District of Columbia, any territory, commonwealth or possession of the United States, or any unit of local government from implementing its own laws authorizing the use, distribution, sale, possession, research, or cultivation of medical psilocybin.”

That language is similar to an existing CJS rider that has been annually renewed each year since 2014 prohibiting the use of federal funds to interfere in state medical marijuana programs. Efforts to expand that protection to cover adult-use cannabis laws have passed the House on several occasions but have never been enacted into law.

“I just think that there’s an opportunity to have a more progressive worldview on legalization and on [preventing] harm to people that are, in many ways, receiving huge medicinal benefits or recreational benefits” from cannabis and psychedelics, Garcia told Marijuana Moment in a phone interview on Tuesday before the psilocybin amendment was publicly posted.

If the psychedelics appropriations measure is cleared for the floor and ultimately enacted, it would specifically focus on medical psilocybin laws, so its practical impact may be limited in the short-term given that no states have explicitly authorized it as a therapeutic in the way they have for marijuana, with qualifying conditions and doctor recommendations, for example.

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Advocates File California Ballot Initiative To Legalize Psychedelics For Medical, Therapeutic And Spiritual Use In 2024

Advocates in California filed a ballot initiative with state officials on Friday that would create a right “to obtain and use psychedelics for medical, therapeutic and spiritual purposes” with the recommendation of a doctor. It would also allow adults to possess and use the substances in their home as well as cultivate entheogenic plants and fungi on private property.

Known as the Psychedelic Wellness and Healing Initiative of 2024, the measure is the third psychedelics-related prospective citizen-led measure attempting to qualify for next year’s ballot. Another would legalize psilocybin for adult and therapeutic use, while a third would commit $5 billion to create a state agency focused on advancing research and development of psychedelic therapies.

Dave Hodges, an initiative organizer and the founder of the Church of Ambrosia, in Oakland, acknowledged in an interview earlier this month that the campaign behind the newest proposal is filing its paperwork later than initially hoped. Advocates won’t be able to start gathering signatures until the state attorney general’s office issues the proposal an official ballot title and summary, which can take more than a month.

Hodges said the goal of the proposal is to ensure broad access to psychedelics while ensuring a base level of safety.

“We aren’t just saying, ‘Everybody gets psychedelics!’” Hodges said. “We’re saying you gotta go talk to a doctor first, and if the doctor recommends that you try them, then you can come get them.”

Gov. Gavin Newsom’s (D) recent veto of an adult-use psilocybin bill passed by the legislature this session was a disappointment, he added, “but at the same time, I completely agree with it.” The governor said in his veto statement that he couldn’t support allowing access to psilocybin without first establishing therapeutic standards.

“My church now has over 100,000 members,” Hodges said. “If each of them could have gone and talked to a doctor before having access to psychedelics, I would have considered that a great thing.”

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Eureka, CA Decriminalizes Psychedelic Plant Medicines

Eureka, CA, has passed a resolution decriminalizing entheogens and psychedelic plant medicines, making it the sixth California city to do so and the second such city in Humboldt County.

The Eureka City Council unanimously approved an initiative last week to decriminalize plant medicines such as psilocybin mushrooms within city limits. The announcement came less than two weeks after CA Gov. Gavin Newsom vetoed an initiative which would have decriminalized psychedelics statewide. The City of Arcata, just a few miles to the north, voted to decriminalize in 2021 thanks to efforts by a group who also provided the language used in the Eureka resolution, Decriminalize Nature Humboldt.

According to an article in the Lost Coast Outpost, the resolution was passed without much trouble from the council, though a particular phrase was removed from the language of the bill. The council voted to remove language which seemed to endorse entheogenic plants’ ability to “catalyze profound experiences of personal and spiritual growth.” Not for nothing, but one of recently deceased Johns Hopkins professor Roland Griffiths’ first studies on psilocybin in 2006 was on psilocybin’s ability to induce mystical and spiritual experiences in the user. Much of Griffiths’ later work at Johns Hopkins has been referenced in similar legislative discussions surrounding the legality of psychedelics.

Other than the removal of the aforementioned phrase, the resolution was passed without much protest from the rest of the council members.There were some concerns voiced by local law enforcement representatives, mirroring Gov. Newsom’s concerns about potentially unforeseen consequences to the resolution. City Manager Miles Slattery, however, pointed out that he had consulted with the Arcata Police Department who reported no serious issues to him after just over two years of psychedelic decriminalization. He also pointed out that the City of Eureka only saw five cases of arrests related to entheogens in the previous year and almost every case was related to something more serious such as domestic violence. 

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