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Tuesday, June 16, 2026

 

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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Monday, February 16, 2026

 

OHSU-led research initiative examines supervised psilocybin



Five-year, $3.3 million award is first to study the effect of psychedelic services in community settings





Oregon Health & Science University

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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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Wednesday, September 24, 2025

 Opinion



Religious freedom for psychedelic users? Not without Indigenous truth.

If Christianity genuinely wants to engage with psychedelics, it must repent


(RNS) — The doors for the spiritual use of psychedelics were opened by struggles over peyote for Native Americans.


(Photo by Katherine Hanlon/Unsplash/Creative Commons)


Christine McCleave
September 23, 2025


(RNS) — The recent controversy over an Episcopal priest who was dismissed for promoting psychedelics for spiritual awakening raises urgent questions about how organized religion in America relates to psychedelics. The debate has focused on the safety of these drugs and church authority and doctrine, while ignoring Indigenous Americans’ long history with such medicines and the church’s long, painful history of suppressing them.

Concerns about priests and others becoming psychedelic shamans are valid. Ordination does not grant medical or cultural expertise, and clergy are not automatically qualified to lead plant medicine ceremonies. Indigenous communities, on the other hand, hold deep intergenerational knowledge of these medicines, rooted in protocols of respect and responsibility. Without a similar foundation, even well-meaning Christian leaders indeed risk causing harm, and it makes sense to regulate those who promote psychedelics. Yet the question remains: How will organized religion engage with psychedelics without perpetuating appropriation and erasure of Indigenous people?
RELATED: Episcopal Church removes priest who founded Christian psychedelic society

For centuries, Christian institutions, the Episcopal Church included, criminalized, demonized and worked to eradicate Indigenous traditions that relied on these medicines, even as they thrived by absorbing pagan practices to attract members. Their attempts now to consider or adjudicate practices so long associated with Indigenous spirituality betray theological contradictions and spiritual hypocrisy.

For over a decade, I have researched the harm caused by church-run Indian boarding schools on Native children in the U.S. — institutions designed to erase language, culture and ceremonies, leaving deep scars of post-traumatic stress disorder and other trauma that still affect our communities today. My research showed that these traumas were intentional, rooted in the belief that Indigenous spirituality was a threat to be eliminated. These same abuses were perpetrated around the globe, particularly in the Brazilian Amazon, where the psychedelic substance ayahuasca originates. For communities still healing from church-run attempts to erase language and ceremony, sudden clerical enthusiasm for psychedelics can reopen wounds rather than build trust.


Psilocybe mexicana mushrooms in Veracruz, Mexico, on July 2, 2019. 
(Photo by Alan Rockefeller/Wikimedia/Creative Commons)

For churches to embrace psychedelics without acknowledgment, accountability or reparations now is not only culturally insensitive — it worsens these harms and triggers past trauma.

Legally, much of the wider debate about the spiritual use of psychedelics turns on “religious freedom.” Many advocates of psychedelics favor the Religious Freedom Restoration Act model, in which groups seek exemptions for sacramental use. These pathways rely on legal ground first carved out by Indigenous peoples whose traditions were explicitly targeted by federal bans.

Today’s “religious freedom” advocates include syncretic Brazilian ayahuasca churches operating in the U.S. (such as União do Vegetal and Santo Daime) and a growing number of self-described psychedelic churches whose attorneys petition the Drug Enforcement Administration for RFRA exemptions. What they are pushing for through court orders or Drug Enforcement Agency recognition is narrow but powerful: the right to import, possess and administer otherwise prohibited sacraments such as ayahuasca/DMT and sometimes psilocybin or mescaline, as religious exercise.

The RFRA strategy began with a legal case brought by two Native American Church members who were denied unemployment benefits after being fired for sacramental peyote use. In the resulting 1990 U.S. Supreme Court decision, Employment Division v. Smith, the justices held that neutral, generally applicable laws could apply to religious practice without violating the First Amendment. The backlash was bipartisan: Congress enacted RFRA to restore the “compelling interest/least restrictive means” test for burdens on religion (later limited to the federal government).

In 1994, Congress separately amended the American Indian Religious Freedom Act to explicitly protect Native ceremonial peyote. In 2006, in Gonzales v. O Centro, the Supreme Court applied RFRA to uphold a church’s sacramental ayahuasca, requiring the government to justify prohibitions case by case, and today the DEA processes RFRA petitions for religious exemptions.

In short: The legal door newer groups now walk through was opened by struggles over peyote for Native Americans.

That history also reveals a double standard. Indigenous spiritual practices involving peyote or other medicines continue to face stigma, legal barriers and threats to their supply. This reversal of justice benefits new psychedelic religions, while tribal nations in the U.S. remain vulnerable despite treaty rights and the American Indian Religious Freedom Act.

Today, psychedelics are being recognized as tools for spiritual renewal. But for Indigenous peoples, they are not “new frontiers” or experimental sacraments — they are living traditions that survived generations of suppression. The church should honor this legacy. True healing will not come from adopting what was once condemned but from mending relationships and respecting the knowledge of those who kept these traditions alive.

RELATED: After a decade of controversy, clergy psychedelic study is published

If Christianity genuinely wants to engage with psychedelics, it must repent. It needs to confront its history of suppressing Indigenous spiritual practices and take concrete steps toward reconciliation. This includes recognizing the origins of these medicines, supporting Indigenous sovereignty and conservation, and centering Indigenous voices in discussions about law, theology and practice. Anything less risks repeating history — not as healing, but as another chapter of colonial exploitation.

(Christine Diindiisi McCleave, a member of the Turtle Mountain band of Ojibwe who holds a Ph.D. in Indigenous studies, is the former CEO of the National Native American Boarding School Healing Coalition. The views expressed in this commentary do not necessarily reflect those of Religion News Service.)

Magic mushrooms invent active compound twice



A new study shows that different types of mushrooms use completely different methods to produce the psychoactive substance psilocybin






Leibniz Institute for Natural Product Research and Infection Biology - Hans Knöll Institute -

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Two different pathways of psilocybin biosynthesis 

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Two paths lead to the same molecule: Independently of each other, different genera of ‘magic mushrooms’ have developed two different enzyme pathways that produce the same psychoactive substance, psilocybin – a rare example of convergent evolution in natural product biosynthesis.

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Credit: Tim Schäfer, Leibniz-HKI






“This concerns the biosynthesis of a molecule that has a very long history with humans,” explains Prof. Dirk Hoffmeister, head of the research group Pharmaceutical Microbiology at Friedrich Schiller University Jena and the Leibniz Institute for Natural Product Research and Infection Biology (Leibniz-HKI). “We are referring to psilocybin, a substance found in so-called ‘magic mushrooms’, which our body converts into psilocin – a compound that can profoundly alter consciousness. However, psilocybin not only triggers psychedelic experiences, but is also considered a promising active compound in the treatment of therapy-resistant depression,” says Hoffmeister.

Two paths, one molecule

The study, which was conducted within the Cluster of Excellence ‘Balance of the Microverse’, shows for the first time that fungi have developed the ability to produce psilocybin at least twice independently of each other. While Psilocybe species use a known enzyme toolkit for this purpose, fiber cap mushrooms employ a completely different biochemical arsenal – and yet arrive at the same molecule. This finding is considered an example of convergent evolution: different species have independently developed a similar trait, but the ‘magic mushrooms’ have gone their own way in doing so.

Searching for clues in fungal genomes

Tim Schäfer, lead author of the study and doctoral researcher in Hoffmeister’s team, explains: “It was like looking at two different workshops, but both ultimately delivering the same product. In the fiber caps, we found a unique set of enzymes that have nothing to do with those found in Psilocybe mushrooms. Nevertheless, they all catalyze the steps necessary to form psilocybin.”

The researchers analyzed the enzymes in the laboratory. Protein models created by Innsbruck chemist Bernhard Rupp confirmed that the sequence of reactions differs significantly from that known in Psilocybe. “Here, nature has actually invented the same active compound twice,” says Schäfer.

However, why two such different groups of fungi produce the same active compound remains unclear. “The real answer is: we don’t know,” emphasizes Hoffmeister. “Nature does nothing without reason. So there must be an advantage to both fiber cap mushrooms in the forest and Psilocybe species on manure or wood mulch producing this molecule – we just don’t know what it is yet.”

“One possible reason could be that psilocybin is intended to deter predators. Even the smallest injuries cause Psilocybe mushrooms to turn blue through a chemical chain reaction, revealing the breakdown products of psilocybin. Perhaps the molecule is a type of chemical defense mechanism,” says Hoffmeister.

More tools for biotechnology

Although it is still unclear why different fungi ultimately produce the same molecule, the discovery nevertheless has practical implications: “Now that we know about additional enzymes, we have more tools in our toolbox for the biotechnological production of psilocybin,” explains Hoffmeister.

Schäfer is also looking ahead: “We hope that our results will contribute to the future production of psilocybin for pharmaceuticals in bioreactors without the need for complex chemical syntheses.” At the Leibniz-HKI in Jena, Hoffmeister’s team is working closely with the Bio Pilot Plant, which is developing processes for producing natural products such as psilocybin on an industry-like scale.

At the same time, the study provides exciting insights into the diversity of chemical strategies used by fungi and their interactions with their environment. It thus addresses central questions of the Collaborative Research Center ChemBioSys and the Cluster of Excellence ׅ‘Balance of the Microverse’ at Friedrich Schiller University Jena, within the framework of which the work was carried out and funded by the German Research Foundation (DFG), among others. While the CRC ChemBioSys investigates how natural compounds shape biological communities, the Cluster of Excellence focuses on the complex dynamics of microorganisms and their environment.


Psilocybe cubensis 

Psilocybe cubensis grows worldwide in tropical and subtropical regions, including Central and South America, Southeast Asia, and Oceania. The mushroom prefers moist, fertilizer-rich soils and contains the psychoactive substance psilocybin, which is currently being researched as an active compound for the treatment of therapy-resistant depression.

Credit

Felix Blei, Leibniz-HKI

Journal

Angewandte Chemie International Edition

DOI

10.1002/anie.202512017 

Article Title

Dissimilar Reactions and Enzymes for Psilocybin Biosynthesis in Inocybe and Psilocybe Mushrooms

Article Publication Date

21-Sep-2025


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Monday, June 09, 2025

 

Effects of psilocybin on religious and spiritual attitudes and behaviors in clergy from major world religions




Mary Ann Liebert, Inc./Genetic Engineering News
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Psychedelic Medicine 

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The first peer-reviewed journal to publish original research papers on every aspect of psychedelic medicine including basic science, clinical, and translational research.

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Credit: Mary Ann Liebert, Inc.





A new study in the peer-reviewed journal Psychedelic Medicine showed that psilocybin administration in a sample of clergy from major world religions increased multiple domains of overall psychological well-being, including positive changes in religious attitudes and behavior as well as effectiveness in their vocation as a religious leader. Click here to read the article now.

The late Roland Griffiths, of Johns Hopkins University, along with Stephen Ross and Anthony Bossis, from New York University Grossman School of Medicine, and coauthors, compared a control group of participants to psychedelic-naïve clergy from various major world religions who received two psilocybin sessions: 20 and then 20 or 30 mg/70 kg about 1 month later.

Compared to the control group, “participants who had received psilocybin reported significantly greater positive changes in their religious practices, attitudes about their religions, and effectiveness as a religious leader, as well as in their non-religious attitudes, moods, and behavior,” reported the investigators. “Follow-up assessments showed that positive changes in religious and non-religious attitudes and behavior were sustained through 16 months after the second psilocybin session.”

Participants rated at least one of their psilocybin experiences to be among the top 5 most spiritually significant (96%), profoundly sacred (92%), psychologically insightful (83%), and psychologically meaningful (79%) of their lives.

About the Journal
Psychedelic Medicine is the first peer-reviewed journal to publish original research papers on every aspect of psychedelic medicine, including basic science, clinical, and translational research, as well as medical applications. This journal provides a vital resource for clinicians and patients alike who are invested in the potential efficacy of psychedelic drugs currently undergoing research in preclinical and clinical studies as an alternative or supplement to traditionally manufactured pharmaceuticals to treat depression, anxiety, addiction, demoralization, and other mental health conditions. Visit the Psychedelic Medicine website to learn more.

About Mary Ann Liebert, Inc., a Sage Company
Mary Ann Liebert, Inc. is a global media company dedicated to publishing and delivering impactful peer-reviewed research in biotechnology & life sciences, specialized clinical medicine, public health and policy, and technology & engineering. Since its founding in 1980, the company has focused on providing critical insights and content that empower researchers and clinicians worldwide to drive innovation and discovery.

Journal

Psychedelic Medicine

DOI

10.1089/psymed.2023.0044 

Method of Research

Randomized controlled/clinical trial

Subject of Research

People

Article Title

Effects of Psilocybin on Religious and Spiritual Attitudes and Behaviors in Clergy from Various Major World Religions






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