A federally funded research initiative will enable researchers at Oregon Health & Science University and other organizations to assess the safety and effectiveness of state-regulated access to psilocybin, also known as magic mushrooms.
The five-year, $3.3 million award is funded by the National Institute on Drug Abuse of the National Institutes of Health — a first.
“This is the first federally funded work to study the impact of legal psychedelic services delivered in community settings,” said co-principal investigator Adie Rae, Ph.D., a scientist at the Legacy Research Institute in Portland and co-director of the Oregon Psychedelic Evaluation Nexis, or OPEN. “There is an urgent need to assess the safety of these programs and their impact on substance use before more voters and policymakers are asked to consider their merits and drawbacks.”
In 2023, Oregon became the first state to permit state-regulated access, for people 21 and older, to supervised services involving mind-altering magic mushrooms. This followed a ballot initiative approved by voters in 2020. Colorado subsequently followed suit.
“We expect our project will generate evidence to inform other states considering legal frameworks for psychedelic services,” said co-PI Todd Korthuis, M.D., M.P.H., co-director of OPEN and professor of medicine (general internal medicine and geriatrics) in the OHSU School of Medicine. “Only about 3,000 people have participated in all psychedelic clinical trials combined since the 1950s. This project is an opportunity to learn from tens of thousands of people who will access psilocybin services in Oregon.”
Public interest has been fueled by promising results in recent years from early clinical trials in depression, anxiety and post-traumatic stress disorder.
OHSU President Shereef Elnahal, M.D., M.B.A., said he expects the research to be groundbreaking.
“Oregon’s experience affords a unique opportunity to inform and shape public understanding of the potential benefits and side effects of psilocybin. In effect, Oregon is a laboratory for policymakers around the country,” he said. “This research will be critically important to learn the safety and efficacy profile of psychedelics for mental health treatment.”
Focused on substance use
The OHSU-led initiative will specifically examine psilocybin’s effect on people with substance use disorders.
“If you look at clinical trials conducted so far, the evidence suggests psilocybin may decrease symptoms of depression similar to existing antidepressants,” Rae said. “Even though there is some emerging literature about the effect of psychedelics on tobacco cessation and in the treatment of alcohol use disorder, we need more research to better understand the effect of psychedelics on substance use.”
Korthuis, head of addiction medicine at OHSU, agrees.
“Preliminary data from Oregon show that people are already accessing psilocybin services to help manage substance use,” he said. “The current study will allow us to better understand how accessing state psilocybin services impacts use of alcohol, nicotine and other substance over time.”
Even though psilocybin and other psychedelics have been used for millennia, researchers and state regulators are only beginning to apply modern scientific rigor to the field.
In 2024, an OHSU-led research team published a set of 22 key measures of high-quality services following a series of interviews conducted with experts who have experience facilitating psilocybin use within clinical trials, in ceremonial settings and in traditional indigenous practices.
Oregon is first
Oregon is the first state to permit state-regulated access to psilocybin, but Rae expects other states will follow. Ultimately, it’s possible that it may become a widely accepted therapy.
“I would compare it to something like acupuncture,” Rae said. “With enough evidence that accumulated over time, it became clear that acupuncture treatment reduced other health care costs. The Oregon psilocybin program could wind up in the same zone, as something that’s essentially considered to be alternative medicine.”
Psychedelics may not work for everyone, but they offer hope for many people who struggle with substance use disorder, said co-PI Ryan Cook, Ph.D., assistant professor of medicine in the OHSU School of Medicine.
“People have strong viewpoints when it comes to psychedelics,” he said. “I’m excited to do this study because we are going to rigorously collect and evaluate the data in a way that has never been done before.”
Researchers have already gathered preliminary data from over 300 clients of Oregon psilocybin service providers who have agreed to participate in the research. Researchers are aiming to enlist at least 1,600 willing research participants over the next five years — a significant proportion of the estimated 15,000 people who have participated in psilocybin services statewide in the first two years it’s been officially permitted.
Participants will fill out a baseline survey, followed by six subsequent surveys and interviews for 12 months following their initial psilocybin treatment session.
The study will recruit participants who want to reduce their use of intoxicating substances with and without psilocybin services. It will then compare the outcomes of each group, including potential safety risks and benefits. The researchers will aim to identify specific substances and subpopulations that may be responsive to psilocybin’s effects.
Psilocybin remains a Schedule 1 controlled substance under federal law, along with cannabis, heroin and others.
“Ultimately, people want to know how safe this is, what is the likelihood their symptoms will improve, what are the side effects, and any challenging experiences they should expect,” Rae said. “Right now, we don’t have much to tell clients about any of those things.”
The research is supported by the National Institute on Drug Abuse of the National Institutes of Health, award R01DA060253. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
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