Study finds sustained benefit for people using Oregon psilocybin services

OHSU-led research is the largest study of psychedelics outside clinical trials

Oregon Health & Science University

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People participating in an Oregon Health & Science University-led study of state-regulated psilocybin services reported relief from symptoms of anxiety, depression and post-traumatic stress disorder — with almost two-thirds declaring the experience to be among the most meaningful of their life.

The findings, published today in the journal JAMA Network Open, represent the first multisite study of the legalized psilocybin market approved by Oregon voters in 2020.

“Safety was very similar to what we’ve seen with psychedelics in clinical settings,” said lead author Todd Korthuis, M.D., professor of medicine (general internal medicine and geriatrics) in the OHSU School of Medicine. “That’s important because there was a big question around whether or not safety in carefully controlled psilocybin clinical trials would translate into real-world use.”

Oregon voters approved a non-medical wellness model, making state-licensed access to mind-altering “magic mushrooms” available for people aged 21 and older starting in 2023.

Senior co-author Adrianne R. Wilson-Poe, Ph.D., a scientist at the Legacy Research Institute and, with Korthuis, co-director of the Oregon Psychedelic Evaluation Nexis, noted that participants reported lasting benefits with few adverse events.

“This paper is going to be cited for decades,” she said. “This is the first large-scale study to monitor the safety and mental health symptoms of real people in the real world.”

The study enlisted 346 people who joined licensed facilitators for a single session using psilocybin between November 2024 and June 2026. Participants reported their state of mind at baseline, one week, one month and three months after single psilocybin sessions at 24 licensed service centers in Oregon.

Participants reported their experience through a web-based portal, with 90% continuing to do so through three months. Key findings:

• At one month, 91.5% felt they benefited and 64.9% ranked the experience among the 10 most meaningful of their life.
• At three months, participants reported decreased moderate-to-severe symptoms of depression, anxiety and PTSD. They also reported improved mental wellbeing and life satisfaction.
• Few reported their experience as harmful, although four who used psilocybin for the first time experienced adverse behavioral reactions that required medical attention. No participants reported a serious event related to their physical health.

The findings will be presented today as part of a Psychedelic Innovation Summit in Portland co-hosted by OHSU and the Healing Advocacy Fund.

“These early results reveal psilocybin’s potential to improve health in people accessing these services here in Oregon,” said OHSU President Shereef Elnahal, M.D., M.B.A., who previously served as undersecretary of health in the U.S. Department of Veterans Affairs.  “The study also provides important insight for policymakers considering programs that permit psychedelics for the treatment of mental health conditions, including PTSD and substance use disorders affecting America’s military Veterans.”

High safety profile

Korthuis noted that psilocybin isn’t appropriate for people with psychosis, bipolar disorder or who are pregnant. However, he was struck by the low incidence of adverse events among participants in the study. Only seven participants reported the experience as harmful three months after their use of psilocybin.

“This may be a reflection of clients who were healthier overall than clinical trial participants,” Korthuis said. “The results demonstrate it’s safe for people receiving state-regulated psilocybin experiences.”

In contrast to previous clinical studies examining safety and effectiveness in treating moderate to severe depression, only about half of the Oregon study participants reported symptoms of moderate to severe depression beforehand. Even so, most participants reported improvements in their mental health, wellness and life satisfaction following their psilocybin session.

“Just because something isn’t a medical model doesn’t mean you can’t have mental health benefits,” Korthuis said. “Still, people serious mental health or medical conditions should talk with their healthcare providers before seeking services.”

Previous research, including imaging of the brain, indicates physiological changes that may help people to reset how they process information and view themselves, he said. More than 20,000 people have accessed Oregon licensed psilocybin services to date, seeking improved general health and wellness along with the potential of changing their perspective, according to data tracked by the Oregon Health Authority.

A $3.3 million, five-year federal grant awarded earlier this year will enable OHSU researchers to specifically examine psilocybin’s effect on people seeking state psilocybin services to reduce use of illicit substances. 

Wilson-Poe said the survey platform developed through this research initiative approved by OHSU’s Institutional Review Board can be easily adapted to measure outcomes from other forms of psychedelics even beyond Oregon — especially as other states consider policies to expand access. OPEN has already expanded to Colorado, the second state to approve regulated psilocybin services.

“It can give us an apples-to-apples comparison,” she said.

In Oregon, a major barrier to access is the cost, which ranges from hundreds to thousands of dollars for a session involving a state-licensed facilitator. In addition, several counties have opted not to permit psilocybin service centers at least in part due to concerns about the safety of psychedelics, whether they’re used medicinally or recreationally.

“Those counties may find this data reassuring, as may policymakers considering similar measures in other states,” Korthuis said.

In addition to Korthuis and Wilson-Poe, co-authors include Ryan Cook, Ph.D., Devin Gregoire, M.S., Kelli Pertl, M.P.H., Dennis McCarty, Ph.D., Ximena A. Levander, M.D., and Kim A. Hoffman, Ph.D., of OHSU; Christopher S. Stauffer, M.D., of OHSU and the VA Portland Health Care System; Jason B. Luoma, Ph.D., of the Portland Institute for Psychedelic Science; and Don Des Jarlais, Ph.D., of New York University.

The research was supported by the Substance Abuse and Mental Health Services Administration of the U.S. Department of Health and Human Services, grant award 75S20123P00003; the OHSU Foundation; the National Institute on Drug Abuse of the National Institutes of Health, grant awards R01DA060253, K12DA061526 and K01DA055130; and the Oregon Clinical and Translational Research Institute of OHSU through grant award UL1TR002369 through the National Center for Advancing Translational Sciences of the NIH. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the U.S. Department of Health and Human Services.

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Journal

JAMA Network Open

DOI

10.1001/jamanetworkopen.2026.30608 

Method of Research

Survey

Subject of Research

People

Article Title

SafetyandMentalHealthOutcomesofOregonState-Regulated PsilocybinServices

Article Publication Date

19-Aug-2026

World’s largest psychedelic brain study finds hidden order in the chaos

Monash University

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A landmark five-year study by Monash University has found psychedelics reorganise brain patterns, giving clinicians powerful new insights into their therapeutic potential.

Published in leading scientific journal Nature, the research is the world’s largest single-site brain-imaging study of the acute effects of psilocybin, the psychedelic compound found in magic mushrooms.

Researchers used brain imaging to understand what happened in the brains of 62 healthy adults using psilocybin during rest, meditation and while they were listening to music and watching a movie.

Lead author Dr Devon Stoliker, a Turner Impact Research Fellow at the Turner Institute for Brain and Mental Health in the Monash School of Psychological Sciences, said previous research had shown that psychedelics disrupt the usual organisation of brain networks.

“We uncovered hidden order within that disruption,” Dr Stoliker said. 

“Under psilocybin, brain networks that help us process our inner world and the world around us became less distinct, but reorganised into patterns that reflected what people were experiencing.

“This was strongest in people who had more positive psychedelic experiences and felt less separate from the world around them.”

Senior author and Principal Investigator Professor Adeel Razi, from the Turner Institute for Brain and Mental Health in the Monash School of Psychological Sciences, said the changes in brain pattern organisation also changed with participants’ surroundings and focus.

“The patterns changed depending on whether participants were resting, listening to music, meditating or watching a movie,” Professor Razi said.

“This shows that context is not just background to the psychedelic experience. 

“What a person is doing and focusing on shapes how their brain responds.

“For treatment, that reinforces why the environment and what a person does and experiences during the psychedelic session matter.”

This study was carried out at Monash Biomedical Imaging, co-located with the BrainPark where the psilocybin therapy sessions were performed. 

The study combined advanced brain-imaging analyses by co-author Dr Leonardo Novelli with AI analyses by co-author Dr Moein Khajehnejad. 

Dr Stoliker said researchers can now use what they learned in this trial to work towards developing therapies that help patients achieve greater clarity, psychological flexibility and new perspectives.

“People who showed stronger reorganisation also reported greater positive psychological changes the following day,” Dr Stoliker said.

“Until now, brain-imaging studies have mainly told us what happens on average across a group.

“Using artificial intelligence, we could measure this reorganisation in each person.”

Professor Razi said this ability to measure individual responses could have important implications for treatment.

“If translated to patients, this could eventually help clinicians understand how someone is responding and predict who is most likely to benefit,” Professor Razi said.

Australia is the first country in the world to legalise psilocybin for treatment-resistant depression and MDMA for PTSD. 

The United States and other nations are now exploring similar pathways.

“Australia is a trailblazer in this growing area of science, with a distinct global advantage in scaling these therapies responsibly,” Professor Razi said.

“As these countries look to us for direction, research from Monash will provide critical evidence to guide safe and effective implementation.”

Read the research paper: http://doi.org/10.1038/s41586-026-10910-z

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Journal

Nature

DOI

10.1038/s41586-026-10910-z 

Method of Research

Observational study

Subject of Research

People

Article Title

Psychedelics Align Brain Activity with Context

Article Publication Date

19-Aug-2026

COI Statement

F.S.B. is advisor and shareholder at Mindstate Design Labs, and is a scientific advisor for Wavepaths, Ltd and Lilly USA, LLC. O.S. was previously a co-founder of Eudelics AB, but cur- rently has no financial relationship with the com- pany, and is a co-founder of embla.ai AB. K.H.P. is an employee of Boehringer-Ingelheim GmBH & Co KG and serves as Chief Scientist of the Board of Directors of the Heffter Research Institute and is a scientific advisor to the Mind Foundation. R.L.C.-H. is a scientific advisor to TRYP thera- peutics, Osmind, Mindstate Design Labs, Otsuka and Red Light Holland. No other authors declared competing interests.

 

How psychedelics work

Estonian Research Council

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image: 

Psychedelics amplify the relations between representations. They enhance the impression that information makes and the strength of its connection to everything else. In the brain, increased firing in a subset of layer V pyramidal neurons projecting to the thalamus (in the middle) leads to a broad distribution of the signal into apical dendrites of many cortical regions.

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Credit: Borjan Milinkovic, Karl-Kristjan Kaup

Psychedelics like psilocybin (from magic mushrooms), LSD, DMT and mescaline profoundly alter how we perceive, feel and think. After decades of neglect, they are again the subject of serious scientific inquiry, largely because of their promise for treating depression, anxiety, addiction and other conditions. But this therapeutic promise has run ahead of a more basic understanding: while a great deal of attention has gone to whether psychedelics help treat mental disorders, far less has gone to what they actually do in a general sense — the fundamental way they change perception, thought and consciousness. Only by understanding these basic mechanisms can we ever make sense of the therapeutic effects.

There is also a gap in how that basic question has been approached. Most attempts to explain the mechanisms of psychedelics have been pitched at the level of whole-brain neuroimaging — describing how activity across large networks reorganises during a trip. But neuroimaging only ever captures aggregate activity: the summed behaviour of millions of cells at once, not what the individual neurons, receptors and dendrites underneath are actually doing. 

The aim of the new framework published in Neuroscience & Biobehavioral Reviews is to build the explanation from the bottom up, starting with cellular neurobiology and electrophysiology. Thus, the framework starts with the individual neurons, receptors and dendrites that psychedelics actually act on. This matters because a picture grounded in cells can connect the pharmacology of the drug to the lived experience in a way that network maps alone cannot. From this cellular foundation, the authors argue that psychedelics have a single unifying effect, which is called apical hypercontextualisation.

Almost everything about the effects of psychedelics starts at one receptor: the serotonin 2A receptor, or 5-HT2A. There is near consensus in the field that the bulk of psychedelic effects depend on this receptor. Block it, and the psychedelic effects are blocked; the intensity of the trip even tracks how many of these receptors the drug occupies. Researchers agree on that, but the new framework tries to understand how exactly the effect on receptors is linked to global effects seen at the level of brain imaging or cognition.

Crucially, the 5-HT2A receptor is not scattered randomly in the brain. It is most abundant in the cortex, and especially on one type of cell: the layer V pyramidal neuron. These are large, elaborately branched cells that act as the brain's key integrators and as the main output stream from the cortex to deeper structures. Because of these properties, they have long been considered central to consciousness itself.

Here is the part worth slowing down on. A layer V pyramidal neuron has, in effect, two very different sets of branches, and they do different jobs. The basal dendrites, near the cell body, mostly receive local input — the direct, feature-by-feature "what is right in front of me" signal. The apical dendrites are different. They form a long trunk that reaches up and branches into a tuft in the topmost layer of the cortex, and they gather input from far away: distant cortical regions and the thalamus. That input is not object-based or feature-based — it is contextual and associative.

A useful way to picture the difference is this. The basal branches carry the more direct, local signal of the stimulus as it arrives. But that signal, on its own, means very little. The apical branches supply everything the stimulus is bound up with: the wider setting, memories, expectations, and its links to other things active in the mind. And this is the key idea behind contextualisation — a mental object is not first defined by itself and then related to other things. What it is comes from how it relates. The apical compartment is where those relations live, and it has even been suggested to set the boundaries between one mental object and the next.

And this is exactly where the 5-HT2A receptor sits most densely. The main target of psychedelics is the very part of the neuron responsible for context and relation.

Now we can much better understand what psychedelics do. They tip these neurons toward their apical, context-gathering side. Normally, a layer V neuron fires based on a balance between its direct, local input and its wider contextual input. Psychedelics, acting through the 5-HT2A receptor, weaken the local side and strengthen the contextual side so the cell is driven more by relations and associations than by the raw stimulus in front of it. Because these neurons are among the brain's main output cells, feeding into the thalamus and back out across the cortex, tilting them this way has a large downstream consequence: the contextual signal gets broadcast widely, spreading across many regions instead of staying local. This is exactly what whole-brain neuroimaging has been showing all along — psychedelics make brain activity more global, with normally separate networks talking to each other far more. The contribution of the present framework is to show where that global shift comes from at the level of the cell.

The bigger picture is that psychedelics do not alter the direct neural representation of a stimulus so much as they amplify the relations between representations. They do not enhance the raw sensory information itself; they enhance the impression that information makes and how strongly it connects to everything else. A signal that would normally stay in its lane instead spreads, mingles and gets contextualised by whatever else is active. The boundaries between mental objects loosen.

This one idea ties together the classic features of the psychedelic experience. Visually, it explains why psychedelics can leave a lone stimulus intact but disrupt how stimuli relate — strengthening context-dependent illusions, warping the edges between objects, and impairing moving or complex scenes more than simple static ones. In cognition, it explains the flood of remote associations, metaphorical and dream-like thinking, and unexpected insight — the mind making connections it usually cannot reach. It even accounts for why "set and setting" matter so much: if subtle internal representations are amplified and broadcast, then a person's mindset and surroundings can steer the whole experience.

Grounding psychedelic action in this cellular machinery is an attempt to explain psychedelics in properly neurobiological terms: from the physical, biological material the drugs act on. It links receptor pharmacology, dendritic physiology and lived experience in one framework, and it explains, rather than merely restates, what the neuroimaging has been showing — with direct implications for how these drugs might reset rigid patterns of thought in mental illness. Ultimately, psychedelics do not change what we represent, but how our representations relate to one another.

---

Journal

Neuroscience & Biobehavioral Reviews

DOI

10.1016/j.neubiorev.2026.106876 

Method of Research

Literature review

Subject of Research

Not applicable

Article Title

Cellular mechanisms of serotonergic psychedelics - apical hypercontextualisation

 

One plant, three kingdoms, five trips

Weizmann Institute scientists decipher how a well-known psychedelic substance is created, then engineer a plant to produce several psychedelics at once

Weizmann Institute of Science

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Long before scientists began studying them in the lab, mind-altering substances were already being gathered from plants, fungi and even animals for use in rituals, healing practices and mental health treatment. Researchers at the Weizmann Institute of Science have now managed to bring together in a single organism five psychedelic substances that in nature are scattered across the tree of life. After uncovering how plants naturally produce one of the best-known psychedelic compounds, DMT, they were able to reengineer that process step by step inside a model plant – along with four other psychedelics. The result is what amounts to a biological factory that could, in the future, be used to simultaneously produce multiple psychedelic molecules, including some that do not naturally occur in plants.

The study was led by Dr. Paula (Shirley) Berman, who worked at the time in Prof. Asaph Aharoni’s lab in Weizmann’s Plant and Environmental Sciences Department; she is now a principal investigator at the Agricultural Research Organization – Volcani Institute. The findings were recently published in Science Advances.

The five compounds in the study – all well-known psychedelics – come from three different kingdoms of life. The plant kingdom contributed DMT, the brain-active component of ayahuasca, a ceremonial hallucinogenic brew long used in shamanic Amazonian rituals for spiritual healing. The researchers derived DMT from several plant sources, including the leaves of a woody shrub from the coffee family, native to the Amazon rainforest, and the bark of an acacia species native to the Australian outback.

From the kingdom of fungi they took psilocybin and psilocin – the compounds responsible for the effects of “magic mushrooms,” with psilocybin once having been central to Aztec ceremonies. Representing the animal kingdom was the Sonoran Desert toad; it has glands on its head and skin that release a milky defensive secretion when it is stressed. This secretion contains bufotenin, as well as a more potent relative of DMT called 5-MeO-DMT, known to induce distinct psychedelic experiences – a fact well-known by those who have sought out the toad with the express purpose of licking it.

Despite their diverse origins, all five compounds belong to the same chemical family and share the same starting point: tryptophan, a common amino acid found in all living organisms. This is also the starting point the human body uses to produce serotonin, a neurotransmitter involved in regulating mood and well-being. That shared origin helps explain why psychedelics act on the same receptors in the brain as serotonin.

“At the heart of the study was the challenge of making DMT,” explains Aharoni.

Although scientists had previously mapped the general route of DMT production in nature, the exact genes and enzymes responsible were still unknown, and identifying the complete biosynthetic DMT pathway remained elusive. The researchers began by identifying the key genes, particularly those encoding the enzymes that drive each step of the pathway. They then inserted these genes into a model plant – Nicotiana benthamiana, a tobacco relative widely used in research – effectively teaching it to produce DMT. Within days, the engineered plant began generating the compound.

When the scientists produced the other four psychedelics individually in separate tobacco plants, one of them – 5-MeO-DMT – was manufactured in surprisingly low amounts. To address this, the team collaborated with Prof. Sarel Fleishman and Dr. Olga Khersonsky of Weizmann’s Biomolecular Sciences Department, experts in protein design. They identified a subtle problem: a molecule that did not fit well into the active site of one of the enzymes. By changing a single building block – one amino acid – in the enzyme’s structure, they improved the fit.

The result was dramatic. “We mutated one amino acid in the sequence and got a 40-fold increase in the production of 5-MeO-DMT,” Berman says.

The scientists then introduced genes for the five compounds into the same plant. The system worked. A single plant was able to produce all five psychedelics: plant-origin DMT; fungus-origin psilocin and psilocybin; and animal-origin bufotenin and 5-MeO-DMT.

“In effect, we created a kind of biological ‘cocktail’ – not by mixing substances externally, but by combining the underlying pathways inside one organism,” Aharoni says.

At the same time, the experiment revealed an important limitation. When multiple pathways were activated at once, they began to compete for the same starting material. In biological terms, the system reached a bottleneck, and production efficiency dropped.

Finally, the team pushed the system beyond what occurs in nature. By adding bacterial enzymes, they produced modified psychedelic molecules carrying chlorine or bromine atoms in specific positions – something that evolution had apparently left out of the plant’s job description but might prove therapeutically valuable. Several such molecules have already shown intriguing biological activity, including antidepressant-like effects, as part of the growing search for new treatments for disorders such as depression, anxiety, PTSD and addiction.

The research points toward new ways of producing psychedelic compounds. Many are currently obtained from slow-growing plants, rare fungi or animal sources, often raising ecological and ethical concerns. The Sonoran Desert toad, for example, is increasingly threatened by habitat loss and overcollection. Plants used for ayahuasca are also under growing pressure due to land loss and rising demand.

Producing these molecules in fast-growing laboratory plants could provide a more sustainable alternative, reducing the need to harvest vulnerable species while making production more efficient and scalable. Plants are grown, the genes are introduced, and within about a week, measurable amounts of the psychedelic can be extracted. 

More available molecules mean more opportunities for research. One open question is why plants produce these compounds in the first place. Psychedelic molecules did not evolve so humans could “trip,” or to treat anxiety or depression; they likely serve ecological roles, such as defense or interactions with microbes and insects. By engineering plants to produce them in controlled settings, researchers can begin to study these possibilities directly.

“If we can move these pathways into a model plant that grows quickly and is easy to manipulate, we can start asking what these compounds actually do for the plant,” Berman explains. Researchers can examine how they affect the plant’s defenses or whether they influence its growth or stress responses.

The scientists are now also exploring the possibility of engineering a plant that produces the full ayahuasca mixture. In traditional preparations, DMT is combined with another compound that allows the brew to be active when swallowed. In the Amazon, this is achieved by mixing leaves containing DMT with twigs bearing another substance that facilitates DMT’s absorption from the digestive tract. Scientists now aim to create a single plant that would contain both components.

Yet another potential direction involves producing therapeutic psychedelics in edible plants, so the substances could be consumed in carefully regulated doses.

All in all, the Weizmann study is not only about psychedelic compounds. It points to a broader shift in the relationship between plant biology and drug development – one in which plants are no longer just sources of rare molecules, but living platforms for studying, reshaping and potentially producing the next generation of psychiatric treatments.

Also taking part in the study were Janka Höfer, Herschel Mehlman, Efrat Almekias-Siegl, Dr. Sagit Meir and Dr. Ilana Rogachev of Weizmann’s Plant and Environmental Sciences Department; Dr. Let Kho Hao of Weizmann’s Plant and Environmental Sciences Department and the Agricultural Research Organization – Volcani Institute; Drs. Yonghui Dong, Uwe Heinig and Yoav Peleg of Weizmann’s Life Sciences Core Facilities Department; Dr. Shahar Cohen from the Agricultural Research Organization – Volcani Institute; and Dr. Liron Sulimani and Prof. David Meiri from the Technion – Israel Institute of Technology.

Prof. Asaph Aharoni’s research is supported by Marc & Joëlle Melviez-Zysman; the Sklare Family Plant Growth Facility Fund; Monica Rosenzweig Armour; Magnus Konow in honour of his mother Olga Konow Rappaport; the Harry and Jeanette Weinberg Plant Molecular Genetics Research Center; the Knell Family Institute for Artificial Intelligence; the Melvyn A. Dobrin Center for Nutrition and Plant Research; the Charles W. and Tillie K. Lubin Center for Plant Biotechnology; and the Tom and Sondra Rykoff Fund for Plant, Environmental, and Sustainability Research.

Prof. Aharoni is the incumbent of the Peter J. Cohn Professorial Chair.

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Journal

Science Advances

DOI

10.1126/sciadv.aeb3034 

 

Researchers receive funding to launch USC’s first clinical study of psilocybin for mental health

The goal of USC’s first-ever study of psychedelic therapy is to conduct a clinical trial to determine whether mindfulness meditation training can augment the potential benefits of psilocybin therapy for mental well-being and cognitive function

Keck School of Medicine of USC

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Researchers at the Keck School of Medicine of USC, the Brain and Creativity Institute at the USC Dornsife College of Letters, Arts and Sciences, and the USC Norris Comprehensive Cancer Center have launched the University of Southern California’s first study of psychedelic therapy. This clinical trial focuses on psilocybin, a psychedelic chemical found in certain types of mushrooms throughout the world, which has shown promise for treating substance abuse and other mental health disorders. Recruiting healthy community-based volunteers, the research team hopes to determine if structured mindfulness meditation training can augment psilocybin-assisted therapy, using a comprehensive battery of physiological, biological, cognitive, and psychosocial measures.

The research is being funded by an award from the Advanced Research Projects Agency for Health (ARPA-H) through its Evidence-Based Validation & Innovation for Rapid-Acting Treatments (EVIDENT) initiative. The initiative is designed to help spur the development of more effective treatments and more personalized care for people with mental or behavioral health disorders.

The study is co-led at USC by Rael Cahn, MD, PhD, director of the USC Center for Mindfulness Science and clinical associate professor of psychiatry and the behavioral sciences and Caryn Lerman, PhD, director of the USC Norris Comprehensive Cancer Center and Distinguished Professor of Psychiatry and Behavioral Sciences, and Psychology, both in the Department of Psychiatry and the Behavioral Sciences at the Keck School of Medicine. The study will be conducted at Cahn’s lab at the USC Brain and Creativity Institute (BCI) and in collaboration with other BCI researchers, including Assal Habibi, PhD, director of the USC Center for Music, Brain and Society, Jonas Kaplan, PhD, co-director of the USC Dornsife Cognitive Neuroimaging Institute and John Monterosso, PhD,  professor of psychology at USC Dornsife.

Psilocybin and mental health

Psilocybin profoundly alters perception, mood and cognition, in some cases causing people to experience distorted sights and sounds or lose their sense of time and space. Research suggests that, with sufficient therapeutic support, psilocybin therapy can lead to emotionally meaningful spiritual experiences.

Although it is currently listed as a Schedule 1 drug under the Controlled Substances Act, the FDA has recently granted psilocybin a “breakthrough therapy” designation for its potential in treating major depressive disorder and treatment-resistant depression. Preliminary evidence suggests it may improve the conditions substantially compared to other available treatments. Other research has shown promising results for its use in treating addiction. 

“Psilocybin-assisted therapy has the potential to revolutionize how we approach mental health research,” said Caryn Lerman. “There is growing evidence that these treatments may have important applications not only for addiction, but also for improving quality of life and emotional well-being for people facing serious illness and end-of-life challenges. This study allows us to rigorously explore that potential while contributing valuable data to a national research effort.”

 The trial will evaluate the potential benefits of offering psilocybin within an eight-week mindfulness meditation training program.  Participants will be randomized to receive psilocybin alone under supervision or psilocybin with mindfulness training, a systematic method to help focus awareness and attention through a series of meditative practices. Mindfulness training has been shown to produce significant mental and physical health benefits, leading the researchers to hypothesize that combining it with psilocybin could lead to improved outcomes over psilocybin assisted therapy on its own. 

Evaluation with comprehensive data

Researchers will enroll approximately 72 middle-aged adults from the Los Angeles community who have no current psychiatric or medical pathology and no previous experience with psychedelic use or meditation practice.  Participants will receive psilocybin-assisted therapy sessions as part of a structured therapeutic protocol offered at the USC Brain and Creativity Institute. The trial will be open label, so participants and researchers will know which treatment they’ve been assigned.

Participants will also complete a comprehensive series of assessments, including EEG, brain MRI/fMRI scans, salivary, blood, and stool samples as well as psychological and cognitive measures before and after treatment. They will also complete follow-up surveys at approximately 3 months, 6 months, and one year after the treatments. Researchers will evaluate the data to determine potential effects on psychological well-being, spirituality, cognitive functioning, brain activity related to self and narrative processing, and biological markers related to inflammation and brain health.

“Mindfulness meditation practice provides people with the tools to deconstruct unhelpful narratives, a process that may be amplified by psilocybin-assisted therapy,” said Rael Cahn. “By combining mindfulness training with psilocybin-assisted therapy, we hope to better understand how these practices may enhance both the potential immediate and longer-term effects of psychedelic medicine.”

About the study

The study is supported by ARPA-H’s EVIDENT program, which aims to accelerate behavioral health research through detailed, real-time clinical data collection. Using digital tools, brain measures, and biological sampling, EVIDENT-supported studies contribute de-identified data to a secure national repository, helping researchers identify patterns associated with rapid changes in mental health. ARPA-H is an agency within the U.S. Department of Health and Human Services that supports bold, high-impact research designed to transform health outcomes.

This research was funded, in part, by the Advanced Research Projects Agency for Health (ARPA-H). The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the U.S. Government

 For more information about ARPA-H, visit ARPA-H.gov.

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