When Oregon voters approved regulated psilocybin services in 2020, they launched a public health experiment unlike any in the United States. Now, for the first time, federal researchers will study what happens when people access psychedelic treatment outside tightly controlled clinical trials.
A five-year, $3.3 million grant from the National Institute on Drug Abuse of the National Institutes of Health will support scientists at Oregon Health & Science University (OHSU) and collaborating institutions as they assess the safety and effectiveness of Oregon’s state-regulated psilocybin services.
“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., co-director of the Oregon Psychedelic Evaluation Nexus, 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.”
From Ballot Measure to Public Health Experiment
In 2023, Oregon became the first state to allow supervised psilocybin services for adults aged 21 and older, following the passage of a 2020 ballot measure. Colorado has since adopted a similar approach with its own regulatory framework.
This policy change brought psilocybin out of the margins of research and into a regulated, real-world setting. Previously, most psychedelic research depended on small clinical trials conducted under highly controlled conditions. OHSU researchers estimate that since the 1950s, only about 3,000 individuals have participated in all psychedelic clinical trials combined.
“We expect our project will generate evidence to inform other states considering legal frameworks for psychedelic services,” said co-principal investigator Todd Korthuis, M.D., M.P.H., professor of medicine at OHSU. “This project is an opportunity to learn from tens of thousands of people who will access psilocybin services in Oregon.”
Interest in psychedelic therapy has increased as early clinical studies have suggested potential benefits for conditions such as depression, anxiety, and post-traumatic stress disorder. However, most available evidence is based on data from carefully selected trial participants under medical supervision, rather than broader use in a real-world setting.
A Focus on Substance Use
The OHSU-led study will focus on individuals who are seeking support for 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, who leads addiction medicine at OHSU, pointed out that early state data indicate many Oregonians are already turning to psilocybin services to address alcohol, nicotine, and other substance use. “The current study will allow us to better understand how accessing state psilocybin services impacts use of alcohol, nicotine and other substance over time,” he said.
Researchers have already gathered initial data from over 300 clients of licensed psilocybin providers. Over the next five years, the team plans to enroll at least 1,600 participants, representing a significant share of the estimated 15,000 individuals who have accessed services statewide in the program’s first two years.
Participants will take a survey before their first session, then complete six additional surveys and interviews over the course of a year. The study will also include participants trying to cut back on substance use without psilocybin, so researchers can compare the groups. The team will assess both potential benefits and safety risks and determine whether certain substances or groups of people respond differently.
A Regulatory Paradox
Even though Oregon has implemented a legalized framework for psilocybin, it is still a Schedule I controlled substance under federal law. This status has made large-scale research difficult and created a gap between new policies and scientific knowledge.
OHSU President Shereef Elnahal, M.D., M.B.A., described Oregon as a testing ground for the rest of the country. “Oregon’s experience affords a unique opportunity to inform and shape public understanding of the potential benefits and side effects of psilocybin,” he said. “In effect, Oregon is a laboratory for policymakers around the country.”
Rae compared the trajectory of psilocybin to acupuncture, which gained broader acceptance after accumulating evidence of clinical and economic benefits. “With enough evidence that accumulated over time, it became clear that acupuncture treatment reduced other health care costs,” she said. “The Oregon psilocybin program could wind up in the same zone, as something that’s essentially considered to be alternative medicine.”
A Goal of Public Awareness
As more states consider similar policies, federal funding for this research signals a shift in approach. Instead of debating whether psychedelic services should exist, researchers are now looking at how these services actually work.
“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.”
Austin Burgess is a writer and researcher with a background in sales, marketing, and data analytics. He holds a Master of Business Administration, a Bachelor of Science in Business Administration, and a Data Analytics certification. His work combines analytical training with a focus on emerging science, aerospace, and astronomical research.