A bill proposed in the Arizona state legislature would provide $30 million in grants for controlled trials to study the drug’s effects on various mental health conditions. Photo from Getty Images
Arizona veterans struggling with their mental health want new solutions, and Dr. Sue Sisely believes that psilocybin, the psychedelic ingredient in “magic mushrooms,” could be the answer.
But so far the only controlled trials on psilocybin to treat medical conditions have used a synthetic, one-molecule version of the substance, which is vastly different from a whole mushroom, which contains hundreds of compounds. And, anecdotally, people who use mushrooms illegally at home are seeing much better results than those in the trials.
“These agricultural products are very complex, and that is what people are reporting benefit from,” Sisley told the Arizona Mirror. “Nobody in the world has access to synthetic psilocybin unless you’re in one of these big pharma trials.”
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That’s why Sisely is advocating for a bipartisan bill proposed in the Arizona legislature that would put $30 million in grants over three years toward clinical trials using whole-mushroom psilocybin to treat mental health conditions like depression and PTSD.
House Bill 2486 was introduced by Republican Rep. Kevin Payne and is backed by Democratic Reps. Jennifer Longdon and Stacey Travers, along with Republican Sen. T.J. Shope. The bill has been assigned to the Health and Human Services and Appropriations committees.
Payne was unavailable for more than a brief comment, but acknowledged Sisley was a major driver behind the bill. The rest of the bill’s sponsors either didn’t respond or declined a request for comment from the Mirror.
Sisely is an internal medicine physician, in addition to the principal investigator at Scottsdale Research Institute, which conducts nonprofit drug development research on psychedelics.
In her own practice, she’s seen people dealing with addiction and trauma get “tremendous benefits” from taking mushrooms.
“It’s curbed their suicidality, it’s put their PTSD into remission, it’s even mitigated their pain syndromes,” Sisely said. “It’s shown evidence of promoting neurogenesis (the growth and development of nerve tissue.) There’s all kinds of great things that are being uncovered, but they’re not in controlled trials — they’re anecdotes from veterans and other trauma sufferers.”
But the people treating themselves with psilocybin must do so underground, because the compound is illegal in Arizona and every other state besides Oregon, whose voters opted in 2020 to legalize it for recreational use for those 21 and older, with the law taking effect at the start of this year.
Payne’s bill would provide funding for competitive research grants for phase I, II and III clinical trials of whole-mushroom psilocybin that could be approved by the U.S. Food and Drug Administration to treat mental health conditions including: PTSD, long COVID-19, depression, anxiety disorders, end-of-life distress, OCD, substance abuse and addiction disorders, eating disorders, chronic pain, inflammatory disorders, autoimmune disorders, seizure disorders and other degenerative disorders.
Phase I trials determine if the treatment is safe, phase II trials determine if a medicine works and phase III trials determine if the substance is better than what’s currently available to treat the studied conditions, according to the American Cancer Society.
The bill specifies that, when looking for participants, the trials should prioritize volunteers who are veterans, first responders, frontline health care workers and people from underserved communities.
Sisely has seen that both veteran patients who are self-dosing psilocybin to treat addiction and Native Americans who use psychedelics in ceremonies have “robust therapeutic responses” to the drug.
“I’ve seen these people, many times for years and years, and nothing has worked,” Sisely said. “I believe this deserves to be studied in a rigorous, controlled environment.”
Veteran suicide continues to be an issue across the country, including in Arizona. In 2020, the latest year from which data is available, 6,146 veterans died by suicide across the country, and around 200 of those were in Arizona.
The official numbers are down from previous years, but Sisely said that many believe the actual numbers are much higher, since not every death by suicide is officially classified as such, especially when it comes to drug overdoses.
As a lifelong Republican, Sisely is hoping that the bill will receive more support from that side of the aisle.
“This is why this is such a bipartisan issue, because everybody has got family or themselves who are struggling with ailments that are not responsive to traditional meds,” she said.
Typically, those conducting clinical trials have a difficult time getting approval if they intend to use a plant instead of a synthetic chemical, Sisely said. The Food and Drug Administration will usually reject those proposals, saying the substance to be studied is too complex.
But Sisely is hopeful that, if this bill is approved by the state legislature, the FDA might give it more serious consideration.
“When the weight of a state government is behind a study, it’s harder for the FDA to reject it,” she said.
If the bill passes, the grants will be awarded by July 1 of each year for three years, to be postponed to the following year if there’s not a proposal for a trial that meets the criteria for a grant.
The bill would also create a psilocybin research advisory council to establish criteria for the trials, oversee the application process and to award grants to the most credible proposals.
The advisory council would have to include: One member who has a federal license to study psychedelics; a military veteran; an Arizona law enforcement officer and a professor or researcher from a university under the jurisdiction of the Arizona Board of Regents who specializes in clinical research or psychedelic studies.
The advisory council would also be charged with making recommendations to the governor, speaker of the state House, the president of the Senate and Department on Psychedelic-Assisted Therapy, based on current federal and state research policy.
Anyone participating or working in the study can’t be charged or prosecuted for possession of psilocybin while working on the trial. This is an important point, because in Arizona, psilocybin is considered a dangerous drug, on the same level as cocaine, methamphetamine, LSD and ecstasy, and getting caught with it could mean a felony charge.
While psilocybin is now legal in Oregon, adults are only allowed to use it when guided through the process by a state-certified facilitator. The drug is not sold directly to customers through a dispensary like marijuana is in Arizona.
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