A mushroom light. (Photo | Isiah Holmes)
Proposed legislation in Wisconsin would create a trust fund for researching medicinal uses for psilocybin, the active compound in so-called “magic mushrooms.” The bill (LRB-4215/1), if passed, would also establish a new pilot study examining the effectiveness of psilocybin on reducing Post Traumatic Stress Disorder (PTSD) symptoms in military combat veterans.
Participants would have to be 21 years of age or older and suffer from “treatment-resistant PTSD,” according to the bill’s language. Law enforcement officers would not be eligible for this study, and the psilocybin used in the research must be acquired through means approved by the federal Food and Drug Administration (FDA).
Bill author Sen. Dianne Hesselbein (D-Middleton) told Wisconsin Examiner that looking at treatment for veterans is a unifying issue in a politically divided state. “I think that’s one thing that we can all agree on in this Capitol,” Hesselbein told Wisconsin Examiner. “Veterans are important, and they deserve the best health care treatment they can get. And if this can help people with PTSD and have them be really great members of society and working and really helping them with their mental health, let’s give it a go. Let’s see if it can work.”
Sen. Jesse James (R-Altoona) co-authored the Senate version of the bill with Hesselbein. Both legislators serve on the Mental Health Committee in the Senate. “He’s a good partner talking about those things, and maybe we can get some movement,” Hesslebein said.
“Wisconsinites, especially our veterans struggling with treatment-resistant PTSD, deserve the ‘Right to Try’ the best possible care and support,” Rep. Nate Gustafson (R-Neenah), co-author with Rep. Clinton Anderson (D-Beloit) of the Assembly version of the bill, wrote in an email to Wisconsin Examiner. “I am proud to work across the aisle to propose a bipartisan bill to create a medicinal psilocybin treatment pilot to fulfill our moral duty to our veterans, who have selflessly served our country.”
Right to Try is a term of art that describes a legal pathway for patients diagnosed with life-threatening diseases or conditions who have exhausted all approved treatment options and are unable to participate in a clinical trial to access certain drugs that have not been approved by the Food and Drug Administration (FDA).
Anderson said in a statement, “Veterans who are diagnosed with PTSD can struggle with daily tasks. Those who served our country deserve to seek the treatments which work for them. This is a step in the right direction.”
Opening doors to more effective treatments
One of the clearest and most cited indications of mental health challenges for veterans are suicide rates, which are 58% higher than for non-veterans. The need for new treatment options has opened a window of opportunity for psilocybin, which has had its status as an illegal drug softened in several states. Colorado and Washington D.C. have decriminalized it. Oregon became the first state to fully legalize the drug in 2020. Across the vast majority of the country, psilocybin-containing mushrooms – organisms which grow naturally in North America – remain among the most illegal substances one can be caught with.
In Wisconsin, an island of drug prohibition when it comes to cannabis, the question of who will be granted access to psychedelic medicine is part of the backdrop to the new bill. “I think inclusivity in these trials is vitally important,” Dr. Cody Wenthur, a professor at UW-Madison’s School of Pharmacy, told Wisconsin Examiner. “And is also a mandate from the FDA for when we’re trying to actually go through the approval process.”
Wenthur leads the school’s Psychoactive Pharmaceutical Investigation master’s program, and conducts research including on how to improve access for groups that are often under-represented in clinical trials.
“There’s been a huge push from within the field, as well as from external regulators like in the MAPS [Multidisciplinary Association for Psychedelic Studies] trial, to increase representation in the trials including across racial and ethnic dimensions, socio-economic dimensions, educational dimensions,” Wenthur said. “And I would argue that’s especially important for psychedelics, because there is this interaction between what the drug is doing and the environment in which it’s being given and the therapy that is being provided.”
Trials that are too narrow risk overlooking factors that affect people who don’t look like the individuals who are being studied. In addition to veteran-specific PTSD, psychedelics like psilocybin could provide new treatment pathways for people attempting to recover from drug addiction.
Dr. Christopher Nicholas, a UW-Madison assistant professor who’s focused on the use of another psychedelic compound called 3,4-methylenedioxymethamphetamine (MDMA) for addiction and PTSD treatment, says ensuring there’s a diverse array of therapists who can administer treatment is a concern. “We want to make sure that there’s inclusion,” he told Wisconsin Examiner, “which isn’t historically the case … in the mental health world.” Dr. Wenthur said the reemergence of psychedelic science is a source of optimism. “It’s a recognition of the mental health challenges that are being faced in our society and the need to engage with solutions beyond what we’ve got on the table right now.”
How would a study actually work?
Psychedelic research began in Wisconsin more than a decade ago. Multiple studies have evaluated psilocybin for treating addiction to opioids, methamphetamine, and other issues. “We’ve been busy for the past 10 years in this space,” said Dr. Paul Hutson, director of UW-Madison’s Transdisciplinary Center for Research As the principal investigator for Wisconsin’s first psilocybin study, Hutson has been involved in research members of the public might not know was going on here at all. He also happens to be a constituent in Sen. Hesselbein’s district.
“I actually heard about psilocybin a few years ago,” Hesselbein told the Examiner, explaining that her first conversations on the topic were with Dr. Hutson. “He was telling me all about it, and what it could mean for veterans, especially veterans with PTSD, and started looking into it. And here we go. A few years later, we have rolled out a bill.” Hesselbein understands the concerns around having inclusive studies and access to psychedelic medicine. “There’s a lot of people who have severe trauma and PTSD,” she said. “Let’s start with the veteran population and see if we can make some headway there. And then see what we can do going forward.”
“I think if we see success in Wisconsin – and we also see success in Texas, Washington, and Maryland where all these pilots are also happening – that we can definitely look into domestic violence victims,” Hesselbein said. Becoming a candidate for one of these studies is a rigorous process. Potential candidates, whether veteran or not, undergo comprehensive psychiatric and medical screening. In addition to receiving psychedelic treatment, patients in the new PTSD research program would be supported by clinicians and receive psychotherapy complimenting the psychedelic experience. Patients would undergo multiple sessions of treatments.
Rather than consuming mushrooms, patients who are being studied are given purified and oftentimes synthetic versions of the active compounds. “Those are prepared according to the standards that are needed for the FDA to consider them a drug product that they can evaluate,” explained Dr. Wenthur. “So that would just be taking a capsule with a product as the primary way that we’ve studied them before.”
Synthetic versions of natural substances also lend themselves to being patented by private groups, whom the UW researchers say have not been involved in Wisconsin research. Some of those groups have worked to patent crystalline versions of psilocybin, others have tried creating a standardized synthetic version of the compound which also contains other chemicals. “That’s an approach some companies are taking to try to protect intellectual property,” said Dr. Hutson. “But we feel that using the pure compound has advantages in terms of knowing very clearly how much we’re getting to an individual and also it avoids questions down the road of contamination or adulteration.”
Results which speak for themselves
When it comes to disorders like PTSD, classical psychedelics like psilocybin and MDMA show promise. Dr. Nicholas, whose research has centered around MDMA, reports patients “showing an 80% response” to the treatments. “And a significant percentage of those individuals no longer meet criteria for PTSD in as short as 18 weeks, you know, three doses of MDMA — which is really quite remarkable.” Patients have seen “significant and long-term improvement in PTSD symptoms with MDMA,” Dr. Nicholas added, in addition to decreases in depression, improvements in functional impairment, and other benefits.
While people may associate MDMA with names in the black market like “Molly” or “Ecstasy,” drugs purchased on the street have zero guarantee of purity. Often, substances sold as “Molly” are entirely devoid of MDMA or may have dangerous contaminants like fentanyl.
Positive effects have also emerged from psilocybin research, with decreases of 50% or more in substance use if not outright abstinence after one or two doses of psilocybin within a 12-18 week span of time. “In the depression space we’ve also seen rapid, very rapid, anti-depressant effects with psilocybin that can sustain itself out up to four to 12 weeks after dosing, depending on the study,” Dr. Nicholas told the Examiner. “So we’re seeing these really substantial clinical improvements in a very short amount of time.”
The results were achieved in very controlled settings. What psychedelic researchers and users call “set and setting,” referencing the potential patient’s inner and outer environments going into the psychedelic experience, are profoundly important aspects of the experience researchers are still trying to understand. Many psychedelics, from the South American shamanic brew Ayahuasca to Peyote in North America, have traditionally been used in specific ceremonial settings. Figuring out why certain compounds work best under specific conditions may be another area of study in the near future for the UW team, especially with additional funding.
“One of the other things that psychedelics do, and we’re just beginning to understand the details of this, is modify the structure of neurons in the brain,” explained Dr. Wenthur. “And so for someone who has had a stroke or another neuro-degenerative disorder, that type of activity could be quite interesting. But maybe the psychedelic experience is completely irrelevant for a person who would be trying to regain function after a stroke.”
Dr. Nicholas hopes psychedelic research will open the door to “Right to Try” and expanded access for people seeking effective treatments. The Drug Enforcement Administration (DEA), one of the many gatekeepers for psychedelic research and drug legalization generally, has already decided that “Right to Try” does not supersede the Controlled Substances Act. That said, Dr. Hutson notes that the DEA, FDA, and other government agencies and committees have been very helpful in enabling psychedelic research to occur. “None of these organizations have been obstructive and that’s really, really encouraging,” said Hutson. With more funding supporting psychedelic research in Wisconsin, including in the form of donations, gifts and grants provided for under the current bill, the sky could be the limit.
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