Tag: psilocybin

FDA creates path for psychedelic drug trials

Federal regulators are laying out guidance for psychedelic drug trials for the first time, in a move that could encourage the mainstreaming of substances like magic mushrooms and LSD as behavioral health treatments.

Why it matters: Psychedelics are turning into a multi-billion industry and gaining widespread acceptance after decades of concerns about recreational use of the products — and the high risk for misuse. But research to date has largely been backed by private sponsors.

Driving the news: The Food and Drug Administration on Friday released first-ever draft guidance outlining considerations — including trial conduct, data collection and subject safety — for researchers looking into psychedelic treatments for a variety of conditions, including PTSD, depression and anxiety.

  • The agency filed the 14-page document two days after a bipartisan coalition in Congress led by Rep. Dan Crenshaw (R-Texas) introduced legislation directing the issuance of clinical trial guidelines.
  • It also came as 10,000 attendees and hundreds of exhibitors converged on Denver for what was billed as the “largest psychedelic conference in history,” with guests ranging from New York Jets quarterback Aaron Rodgers to National Institute of Mental Health director Joshua Gordon.

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Cops Bust Psilocybin Grow Operation in Northeast Portland Mansion

On June 8, court documents show, police busted a psilocybin grow house and major interstate mushroom and weed distribution operation in a 5,000-square-foot mansion bordering a Northeast Portland country club.

Oregon voters legalized psilocybin mushrooms in 2020 by passing Measure 109. But the measure only sanctions use of the hallucinogen in tightly regulated therapeutic settings. Such niceties have done little to discourage the expansion of a “mushroom underground,” with state-licensed therapists offering guided trips in private homes and Airbnbs. Psilocybin mushrooms are easily obtained across Portland, even after the shuttering of a retail operation, Shroom House, on West Burnside Street.

A probable cause affidavit filed in Multnomah County Circuit Court on Friday offers some insight into where that supply might be coming from—and alleges that interstate psilocybin traffickers have set up shop in Portland.

It’s not clear from the affidavit what led police to the $1.3 million home bordering Columbia Edgewater Country Club, which features panoramic views of the golf course, a “unique triple barrel-vaulted ceiling,” and parking for 16 cars, according to a real estate listing online.

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Rhode Island Lawmakers Approve Psilocybin Legalization Bill

A Rhode Island legislative committee this week approved a bill to legalize the possession and cultivation of psilocybin mushrooms, making the state the latest of several to propose or advance legislation to ease the prohibitions on magic mushrooms and other psychedelic drugs. The measure, House Bill 5923, was approved by the House Judiciary Committee by a 12-2 vote on Tuesday, according to a report from Marijuana Moment. A companion bill is pending in the Rhode Island Senate, where the chamber’s Judiciary Committee is holding the bill for further study.

If passed, the legislation would eliminate criminal penalties for adults who possess or cultivate up to one ounce of psilocybin mushrooms for personal use. Up to one ounce of mushrooms could also be shared by one adult with another. The bill is slated to go into effect on July 1, and an amendment approved by the Judiciary Committee sets a July 1, 2025, sunset for the legislation.

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LSD and Magic Mushrooms Dramatically Rewire the Brain, New Study Reveals

From ketamine drips to microdosing on LSD, psychedelics are shaking up the way we approach and treat mental health. A growing body of scientific evidence shows that these long-stigmatized substances could be potential antidepressants, alleviating symptoms by slipping into areas of the brain traditional SSRIs can’t reach, and encouraging new neural connections.

Despite these advances, psychedelics remain fairly mysterious. Researchers haven’t yet pinned down the various mechanisms through which they work inside our bodies. But now, they might be one step closer.

An international team of scientists led by the University of Helsinki in Finland believes they’ve struck biochemical gold. In a study published Monday in the journal Nature Neuroscience, the researchers found that psychedelics psilocin (the primary chemical in magic mushrooms) and LSD exert an antidepressant effect by binding to a protein, receptor tyrosine kinase beta (TrkB), which then activates brain-derived neurotrophic factor (BDNF), a protein that plays a crucial role in the growth, development, and maintenance of neurons; kind of like Miracle-Gro for the brain.

“I think [this study] is very exciting,” Greg Fonzo, co-director of the Center for Psychedelic Research and Therapy at The University of Texas at Austin’s Dell Medical School, who wasn’t involved in the study, tells Inverse. “It establishes a potential common mechanism for psychedelics along with other kinds of antidepressant treatments.” The researchers hope that this new information could potentially lead to creating more effective treatments for mental health disorders.

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New Study Analyzes Efficacy of Psilocybin as Treatment for Alcohol Use Disorder

A recent study published in the journal Psychology of Addictive Behaviors by the American Psychological Association on June 5 has found that psilocybin can be an effective treatment for people with alcohol addiction.

Officially entitled “Reports of self-compassion and affect regulation in psilocybin-assisted therapy for alcohol use disorder: An interpretive phenomenological analysis,” the study was conducted by researchers from New York University and University of California, San Francisco, as well as a psychedelic integration and psychedelic-assisted therapy business called Fluence.

The study objective was to “delineate psychological mechanisms of change” for those who suffer from alcohol use disorders (referred to as AUDs). All participants were engaged in interviews about their experiences, and asked questions about their alcohol use before and after the study. They were also asked about their coping patterns when enduring “strong emotions, stress, and cravings for alcohol.”

According to the study results, researchers examined how psilocybin helped them overcome various stressors. “Participants reported that the psilocybin treatment helped them process emotions related to painful past events and helped promote states of self-compassion, self-awareness, and feelings of interconnectedness,” researchers stated. “The acute states during the psilocybin sessions were described as laying the foundation for developing more self-compassionate regulation of negative affect. Participants also described newfound feelings of belonging and an improved quality of relationships following the treatment.”

Through this evidence, they explained that psilocybin “increases the malleability of self-related processing, and diminishes shame-based and self-critical thought patterns while improving affect regulation and reducing alcohol cravings,” the authors concluded. “These findings suggest that psychosocial treatments that integrate self-compassion training with psychedelic therapy may serve as a useful tool for enhancing psychological outcomes in the treatment of AUD.”

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Magic mushrooms go mainstream in Colorado

Fungi are ready for their close-up.

Driving the news: After Coloradans voted to legalize psilocybin in 2022, “magic mushrooms” are now becoming more mainstream, with a first-of-its-kind study and a national psychedelic conference on the horizon.

State of play: The University of Colorado Anschutz Medical Campus in Aurora this month announced it would launch the first modern-era psilocybin clinical trial for depression this fall.

Details: The hospital is working with the Food and Drug Administration on the study, though the federal government classifies psilocybin mushrooms as a Schedule 1 narcotic.

  • It’s grouped with the most serious category of illicit drugs, including heroin and cocaine.

The intrigue: Gov. Jared Polis last week signed a bill implementing Proposition 122, which allows people 21 and older to grow and share magic mushrooms.

  • The bill also creates a regulated therapy system for medicinal use — establishing “healing centers” for people to use psilocybin under supervision — and removes criminal penalties for personal possession.

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Taxpayers May Soon Be Filling the Funding Gaps in Oregon’s Psilocybin System

So far, just three psilocybin service centers—offices where people can go on legal mushroom trips—have been licensed by the state of Oregon.

That’s bad news for law-abiding people itching to avail themselves of the much-advertised benefits of psilocybin: relief from depression, alcoholism, obsessive-compulsive disorder, and end-of-life dread.

It’s also bad news for taxpayers, who may soon find themselves underwriting a shroom system that was supposed to pay for itself.

Proponents of Measure 109, the initiative that created Oregon’s legal psilocybin program, designed it to be funded by fees, not taxpayer dollars, so it would be palatable to more voters. Service centers, mushroom growers, and psilocybin testing labs are all required to pay $10,000 a year for their licenses. Facilitators, the people who sit with tripping subjects and guide them into the psychosphere, pay $2,000 a year.

The problem is that very few people are getting licenses of any kind to cover the cost of running the Oregon Health Authority’s Psilocybin Services unit, in large part because of the high fees. Very few licensees means very little fee revenue, which means the state has to find cash someplace else to keep the program running.

That other place could be the state’s general fund. OHA has asked for $6.6 million to fill the program’s budget gap for the fiscal biennium starting July 1, according to a 13-page “policy option package,” or POP, that’s now sitting in the Legislature (Salem budgets two years at a time).

“Without the additional funding, the sustainability of the work would be jeopardized,” OHA says in the POP document. “There would be insufficient staff to continue to implement the regulatory program, review license applications and conduct licensure inspections. Consequently, psilocybin businesses seeking licensure could experience financial hardship.”

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Salem Leaders Vote Unanimously To Ease Enforcement On Psilocybin

 It’s now a lot easier to use magic mushrooms in the witch city.

The Salem City Council voted unanimously last week to effectively decriminalize Psilocybin mushrooms in the city, which means that police will now deprioritize enforcing laws against the fungi and will not actively look for people that grow, possess, or consume them. City Councilor Jeff Cohen told WBZ’s Shari Small scaling back enforcement on the mushrooms will help certain residents.

“This is primarily about helping people who might have issues like depression or other challenges,” he said. “However, it’s enabling people who grow their own to be able to use it.”

Both Colorado and Oregon have decriminalized psilocybin and allow it to be used for medical reasons. Cities in several states have decriminalized the drugs, including Cambridge and Somerville. While this measure does not fully decriminalize the use of magic mushrooms, it allows people to use them without the fear of being prosecuted for it.

“They’ve done studies on psilocybin for many years, they have a lot of data about how it really does help people,” Councilor Cohen said. “We had scientists and also therapists who talked about their perceived need to have this in their toolbox to help some of the patients they have.”

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Arizona funds research into ‘magic mushrooms’ to treat PTSD and depression

Arizona is headed toward funding the first controlled clinical trials for whole mushroom psilocybin, or “magic mushrooms,” to treat an array of health issues, including post-traumatic stress disorder, anxiety and depression. 

The state’s nearly $18 billion 2024 budget contains a provision providing $5 million for whole mushroom psilocybin trials. The money is the culmination of the efforts of Dr. Sue Sisely, an internal medicine physician and principal investigator at Scottsdale Research Institute, which conducts nonprofit drug development research on psychedelics, along with a bipartisan group of state legislators. 

“We’re thrilled that the research on natural mushrooms will finally be able to move forward, so this is a big achievement that finally we’re going to get objective data,” Sisely told the Arizona Mirror. “This will give us reliable insight into how these mushrooms might help or harm people. We need to learn more about how this works.”

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Small amounts of ‘psychedelic’ mushrooms would be decriminalized in CT, under bill

At a time when more research is showing that the controlled ingestion of psilocybin mushrooms can help patients deal positively with depression, trauma and end-of-life issues, the state House of Representatives on Wednesday approved legislation that would decriminalize the possession of small amounts of the hallucinogenic fungi.

The bill, which opponents warned could lead to the eventual full legalization of the drug, passed 86-64 and next heads to the Senate. Thirteen Democrats voted against the bill and two Republicans voted for it.

If approved in the Senate and signed into law by the governor, the penalty for a first-time possession of a half ounce or less would be $150. State Rep. Steve Stafstrom, D-Bridgeport, co-chairman of the legislative Judiciary Committee, said that a number of patients with behavioral health issues, including substance abuse, can benefit from the use of the drug, also called “magic mushrooms” or psychedelic mushrooms. But the research, much being done at Yale University, is moving slowly because of the illegality of the drug.

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