Psilocybin providers follow safety guidelines, study finds

First look at how centers screen callers reassuring, but cost may impede greater access

Washington University in St. Louis

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In Brief

• Researchers evaluated licensed psilocybin centers in Oregon.
• All centers followed the law for patient screening and treatment provision; none allowed unsupervised use; all asked about psychiatric history, medications and risk factors before recommending services.
• Sessions cost around $1,900, and no center took insurance.

A new study has found that Oregon’s licensed psilocybin centers largely follow recommended safety guidelines, offering reassurance about how the first regulated psilocybin programs in the U.S. function in practice — though the cost of treatment may keep it out of reach for many.

The study, led by researchers at Washington University in St. Louis and the University of Missouri, is the first independent look at how these centers vet their potential clients.

Since 2023, when Oregon became the first state to legalize regulated, supervised psilocybin — the psychoactive ingredient in “magic mushrooms” — it has drawn people with mental health conditions ranging from depression and anxiety to post-traumatic stress disorder and substance use disorders.

Some clinical trials have suggested that psilocybin, combined with psychological support or psychotherapy, can provide relief for some of these conditions, though the drug remains federally illegal. Until now, little has been known about what people actually encounter when they contact a psilocybin center — or what safeguards are in place.

To find out, researchers posing as prospective clients reached 15 of Oregon’s 22 active centers by phone and found that they consistently followed safety practices required by state law: no center allowed unsupervised or take-home use, and staff routinely asked about psychiatric history, medications and contraindications before discussing next steps. These findings complement a recent cohort study in which serious adverse reactions among 346 Oregon clients were uncommon.

The new study is officially published Oct. 12 in Health Affairs Scholar.

“Going in, we wondered whether Oregon’s model might work like a dispensary in practice — that you could call a center, pick up psilocybin and take it home with little screening along the way,” said co-senior author Kevin Xu, MD, an assistant professor of psychiatry at WashU Medicine. “Far from a dispensary model, I was surprised by how service centers asked detailed questions about callers’ mental health and risk factors. Services were also very expensive.”

The research team later interviewed center staff and found that high operating and licensing costs make these services hard to sustain for centers and hard to afford for people who might seek them. Indeed, four of the 26 centers Oregon had licensed closed before the study’s calls began, and another seven could not be reached by phone.

What do prospective clients experience when seeking psilocybin services?

The research team, which included experts in medicine, social work and public health, designed the study to follow the path a real client would take: reviewing the center’s website, then calling to ask questions.

“This latest innovative study highlights our unique interdisciplinary approach to psychedelic science.” 

— Ginger Nicol, MD, WashU Medicine

Three co-authors made scripted calls in which they posed as potential clients with depression and a history of alcohol use disorder or a family history of psychosis. They documented whether staff asked about medications, suicidal ideation and psychiatric history, as required by Oregon’s legal framework for psilocybin services. They also documented the price quoted for services.

“These interactions were not just, ‘Hey, give me mushrooms,’ and that’s it,” said co-senior author Leopoldo J. Cabassa, PhD, a professor at WashU’s Brown School who also co-directs WashU’s Center for Mental Health Services Research. “These were thoughtful conversations where the facilitator engaged people, asked good questions, and tried to get as much information as possible. Facilitators pushed past a simple checklist to actually understand a caller’s history before making a recommendation for services.”

Nearly every center flagged psychoactive medications that should not be combined with psilocybin, and no center advised callers taking antidepressants to stop them without first consulting with their primary care physician.

The median cost of a session was $1,900, and no center accepted insurance, which would limit accessibility if the treatment is legalized in other U.S. states.

“Oregon has dosed more people with psilocybin in a regulated model than anywhere else in the world,” said first author Dani Adams, PhD, an assistant professor of social work in the College of Health Sciences at the University of Missouri and Director of the Collaborative for Missouri Psychedelic-Assisted Therapy, who began this line of research while a postdoctoral fellow at WashU working with Cabassa. “But it is still out of reach for most Americans who are struggling with their mental health.”

Bipartisan efforts to expand psilocybin access

Veterans in particular face high rates of PTSD, depression and suicide, which has fueled bipartisan interest in getting psychedelic-assisted therapy approved by the U.S. Food and Drug Administration (FDA). Cabassa noted that in the meantime, some veterans unable to access or afford regulated care in the U.S. have instead sought unregulated treatments abroad, highlighting the importance of getting domestic access right.

WashU has been a leader in psychedelic research on multiple fronts. Co-author Ginger Nicol, MD, a professor of psychiatry at WashU Medicine, co-directs the Center for Holistic Interdisciplinary Research in Psychedelics alongside Cabassa, and was the principal investigator on a landmark 2024 study in Nature that showed how psilocybin temporarily desynchronizes activity across the human brain, among the first studies to map the drug’s effects at that scale.

“This latest innovative study highlights our unique interdisciplinary approach to psychedelic science,” Nicol said. “The team recognized an opportunity and acted swiftly to collect data that fills a major gap in scientific knowledge.”

With the new study, Cabassa and Nicol noted, WashU’s footprint in the field has grown from understanding brain circuitry to real-world implementation.

“We have to figure out what safeguards are needed and make sure those are maintained as the system solves for accessibility,” said Cabassa.

Adams DR, Hartman M, Gong L, Shankar S, Ling R, Steinle JT, Siegel JS, Nicol GE, Grucza RA, Borodovsky JT, Cabassa LJ, Xu KY. “Am I a candidate for magic mushrooms?” A mystery shopper study of Oregon psilocybin service centers. Health Affairs Scholar. October 12, 2026. DOI: 10.1093/haschl/qxag231

The work was supported by NIH grants K08DA061258 and R25 MH112473. Additional funding came from the WashU PJ000033039 Funding Award, the WashU Center for Dissemination and Implementation, and WashU’s Here & Next Transcend Initiative. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

J.S. Siegel reported former employment by Sumitomo Pharma America; receiving consulting fees from Longitude Capital and Otsuka Pharmaceutical and being coinventor on a provisional patent (No. 020949/US 15060-1787) related to the use of precision functional mapping to assess target engagement of experimental therapeutics. G.E. Nicol reported receiving grants from COMPASS Pathways and Usona; receiving drug supply from Usona; and being a paid consultant for Carelon, Alkermes, Sunovion, and Novartis outside the submitted work as well as serving as codirector of the Washington University Center for Holistic Interdisciplinary Research in Psychedelics (CHIRP), a Transcend Initiative funded by the Washington University Here and Next strategic plan.

About WashU Medicine

WashU Medicine is a global leader in academic medicine, including biomedical research, patient care and educational programs with 3,100 faculty. Its National Institutes of Health (NIH) research funding portfolio is the second largest among U.S. medical schools and has grown 78% since 2016. Together with institutional investment, WashU Medicine commits over $1.6 billion annually to basic and clinical research innovation and training. Its faculty practice is consistently among the top five in the country, with more than 2,550 faculty physicians practicing at 200 locations. WashU Medicine physicians exclusively staff Barnes-Jewish and St. Louis Children’s hospitals — the academic hospitals of BJC HealthCare — and Siteman Cancer Center, a partnership between BJC HealthCare and WashU Medicine and the only National Cancer Institute-designated comprehensive cancer center in Missouri and southern Illinois. WashU Medicine physicians also treat patients at BJC’s community hospitals in our region. With a storied history in MD/PhD training, WashU Medicine recently dedicated $100 million to scholarships and curriculum renewal for its medical students, and is home to top-notch training programs in every medical subspecialty as well as physical therapy, occupational therapy, and audiology and communications sciences.

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Journal

Health Affairs Scholar

Article Title

“Am I a candidate for magic mushrooms?” A mystery shopper study of Oregon psilocybin service centers

Article Publication Date

12-Oct-2026

COI Statement

The work was supported by NIH grants K08DA061258 and R25 MH112473. Additional funding came from the WashU PJ000033039 Funding Award, the WashU Center for Dissemination and Implementation, and WashU’s Here & Next Transcend Initiative. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. J.S. Siegel reported former employment by Sumitomo Pharma America; receiving consulting fees from Longitude Capital and Otsuka Pharmaceutical and being coinventor on a provisional patent (No. 020949/US 15060-1787) related to the use of precision functional mapping to assess target engagement of experimental therapeutics. G.E. Nicol reported receiving grants from COMPASS Pathways and Usona; receiving drug supply from Usona; and being a paid consultant for Carelon, Alkermes, Sunovion, and Novartis outside the submitted work as well as serving as codirector of the Washington University Center for Holistic Interdisciplinary Research in Psychedelics (CHIRP), a Transcend Initiative funded by the Washington University Here and Next strategic plan.

 

Study: Obscure 1967 guide for LSD use still relevant as psychedelics gain in popularity

Survey participants agree with 18 of 19 tips from Lisa Bieberman, largely unknown acolyte of acid guru Timothy Leary

University at Buffalo

BUFFALO, N.Y. ­—  As psychedelic drugs such as LSD gain new momentum as a therapeutic treatment for severe post-traumatic stress disorder (PTSD), depression, and even headaches, a University at Buffalo researcher is exploring safety education for recreational users.

Daniel Kruger, PhD, research associate professor in the School of Public Health and Health Professions, looked back more than half a century for best practices on harm reduction.

In the 1960s, when Harvard psychology lecturer and psychedelics proponent Timothy Leary was advising people to “turn on, tune in, and drop out,” a young Radcliffe College graduate was quietly focused on another aspect of hallucinogens — safety.

Lisa Bieberman, who had been a Leary follower, established the Psychedelic Information Center in Cambridge, Mass. In February 1967, she published the $1 pamphlet, “Session Games People Play: A Manual for the Use of LSD,” which recommended best practices for the use of all types of psychedelics, especially for first-timers. She also addressed what might go wrong during an LSD or psilocybin ("magic”) mushroom trip.

“Bieberman highlights a number of games that may be better avoided during a LSD session, such as running away from your companions and believing that you have unlocked the deepest truths of the universe and need to tell the world about them,” Kruger says. “She also recommended that users stay with people they like and trust, avoid going out in public, and clear their minds of negative emotions.”

He launched a study with Paul Gillis-Smith, program lead at the Center for the Study of World Religious Studies at Harvard Divinity School, in which they surveyed almost 600 self-identified psychedelic users. Their findings, which showed that participants agreed with 18 of 19 pieces of Bieberman’s advice, were published in the Aug. 12 edition of the journal Psychedelics.

Other authors on the study are affiliated with the Michigan Psychedelic Center at the University of Michigan; Blue Sage Health Consulting in Ann Arbor, Mich., the Michigan Psychedelic Society; and the Radical Well-Being Center in Southfield, Mich.

When Kruger discovered Bieberman’s pragmatic teachings, which differed from Leary’s esoteric rhetoric, such as “surrender to the void,” he wanted to see if they would hold up today. It’s a timely inquiry, considering that psychedelic use now exceeds that of the counterculture ‘60s, according to Kruger.

Today, these drugs are gaining new momentum through hundreds of clinical trials and legal pathways in states like Oregon and Colorado, Kruger says.

“The idea is to medicalize these psychedelics for psychiatric conditions such as severe PTSD and depression,” he adds. “There really hasn’t been any big innovations in mental health medications since the selective serotonin reuptake inhibitors were introduced in the 1980s, and they don’t work as well as we originally thought.”

Psychedelics have even been used to treat physical conditions such as cluster headaches, which are so painful that some sufferers have reported suicidal ideation.

“The clinical trials show people are getting better for a range of conditions,” he says. “Some report finding more meaning in life, having greater spiritual connections, and improving their relationships.”

While these trials may offer promise to millions of  people, Kruger notes that the majority of those experimenting with psychedelics are doing so outside of a regulated context and with little prevention education.

 “As a public health professional, I believe we need to protect these users,” he says. “When Lisa’s pamphlet was published, there were few resources for novice users. Although the term ‘harm reduction’ was decades from entering the vernacular of drug use education and safety, we propose that ‘Session Games’ and Bieberman’s larger collection of work are precursors to this approach.”

The anonymous survey participants, who were recruited via online advertisements and in-person outreach at a psychedelic advocacy event in Ann Arbor, Mich., reported using LSD and psilocybin mushrooms, mescaline, ayahuasca, ketamine, and MDMA (ecstasy/molly), primarily within the last year. They ranged in age from 18 to 85, with an average age of 43. Some identified as psychedelic guides or educators.

In regard to how to best prepare for a psychedelic experience, the majority of respondents agreed with the statements: “Be with people who know, like, and trust each other,” and “Be aware that, even with a guide, you have to do most of the work yourself.”

For overall advice, the strongest agreement was with the statements, “Recognize that the experience will eventually end,” and “Recognize that you may experience anxiety, which does not mean that something is wrong.”

Participants neither uniformly agreed nor disagreed with the advice to avoid looking in the mirror during a psychedelic trip, which over the decades has proven to be a scary experience for some users.

“Participants strongly endorsed advice emphasizing interpersonal trust, personal responsibility and psychological preparation – principles thought to be foundations to safe and meaningful psychedelic experiences in clinical research,” Kruger says.

Indeed psychedelics were considered a promising therapeutic tool in the mid-20th century when they used to treat such conditions as neurosis and schizophrenia, along with general psychotherapy. However, by the late 1960s, drugs became criminalized and psychedelic therapy waned.

While classic psychedelic drugs are still illegal in the United States, Colorado and Oregon have established state-regulated frameworks for supervised therapeutic use. New Mexico is not far behind, says Kruger, who predicts that more psychedelics-based medications will enter the marketplace in the not-too-distant future.

“It’s a freight train coming down the tracks,” he says. “So, we better have a train station to safely load passengers into this train or else they’re just going to try to jump on board while this train is moving.”

Kruger notes that the 2026 Psychedelic Community Survey is now available for anyone to take, regardless if they have experienced psychedelics. While all answers are anonymous, he recommends that participants take the survey on a private computer or device in a private location.

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Journal

Psychedelics

DOI

10.1016/j.psyche.2026.100034

Method of Research

Survey

Subject of Research

People

Article Title

Highlighting the legacy of a psychedelic harm reduction pioneer: Assessing contemporary agreement with advice in Lisa Bieberman’s 1967 “Session Games” manual

 

Clinical trial tests psilocybin-assisted therapy for depression in advanced lung cancer patients

It’s the first trial specific to lung cancer using hallucinogenic mushroom-assisted therapy

Ohio State University Wexner Medical Center

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image: 

At The Ohio State University in Columbus, Ohio, Alan Davis, PhD (left) and Theodore Wagener, PhD (right) developed the first-ever clinical trial treating lung cancer patients with psilocybin-based therapy.

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Credit: The Ohio State University Comprehensive Cancer Center

Nearly 40% of people with lung cancer experience depression, and many also face anxiety, hopelessness and questions about mortality after diagnosis. Researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) and the Center for Psychedelic Drug Research and Education (CPDRE) in the College of Social Work (CSW) are leading a clinical trial to test whether psilocybin-assisted therapy can help reduce depression and emotional distress among patients with lung cancer.

An unmet mental health need

This new research addresses a pressing gap in cancer care: Many people with advanced lung cancer are living longer because of treatment advances, but depression, anxiety and distress can still affect daily life, relationships and the ability to cope with treatment.

This is the first study to test psilocybin-assisted therapy for depression specifically in people with lung cancer. The emotional strain can be especially intense for people with lung cancer, yet treatment options for cancer-related depression have changed little as cancer care has improved.

Psilocybin is a naturally occurring psychedelic compound found in certain mushrooms. In this study, it is given in a carefully controlled medical setting with counseling and support from trained therapists.

"There is growing evidence that psilocybin-assisted therapy may help relieve depression in people with cancer, but no study has focused specifically on patients with lung cancer," said Alan Davis, PhD, co-principal investigator of the study and directs Ohio State's Center for Psychedelic Drug Research and Education. "This is the first clinical trial designed to determine whether this approach can address the unique psychological challenges faced by this patient population."

"Many patients are diagnosed with advanced disease and are forced to confront questions about their future very quickly," said Theodore Wagener, PhD, co-principal investigator of the study and director of Ohio State's Center for Tobacco Research. Both Wagener and Davis are scientists with the OSUCCC – James Cancer Control Research Program. "Patients may experience anxiety, existential distress, loss of meaning and concerns about their families. Some also carry guilt tied to the stigma that can be associated with lung cancer."

Researchers say these emotional burdens can affect quality of life, daily routines, relationships and how patients experience cancer treatment.

Testing a guided treatment model

During this clinical trial, researchers will measure changes in depression and emotional well-being to learn whether the approach could offer another option for patients facing advanced cancer.

The trial combines psychotherapy with one supervised dose of psilocybin. Participants first complete about eight hours of preparation with two trained therapists. They then receive psilocybin during a daylong treatment session in a comfortable clinical setting, followed by counseling to help them process the experience.

"From the moment patients enter the study, they are paired with two therapists who support them throughout the entire process," Davis said. "The goal is to help participants feel safe, build trust and make sense of their experiences in ways that may improve their well-being."

Researchers also are studying whether psilocybin may affect inflammation, though more research is needed.

Looking beyond the cancer

For study participant Betty Paschall, the therapy was part of a turning point after a devastating diagnosis. Paschall was diagnosed with stage 4 lung cancer and initially felt overwhelmed by depression despite receiving treatment for her cancer.

"I didn't want to live," she said. "It was like I was the walking dead."

After participating in the study, Paschall said she noticed meaningful changes in her outlook and daily life. She began engaging in activities she had stopped doing and found herself reconnecting with the people and experiences that brought her joy.

"My sister and daughter both saw a difference in me," Paschall said. "I started to get back to myself a little more."

Researchers caution that psilocybin-assisted therapy remains experimental and is not appropriate for every patient. Participants undergo careful screening, and treatment is provided only under close medical supervision.

A successful study, investigators say, could help identify which patients are most likely to benefit and lay the groundwork for larger studies aimed at expanding treatment options for cancer-related depression.

"Cancer care has made major advances, but treatment for the depression, anxiety and distress that can come with advanced cancer has not moved as quickly," Wagener said. "We hope this research helps us better support the whole person, not just the cancer."

More Information 

Patients interested in being screened to participate in the study should contact Angela Douglas at douglas.496@osu.edu. To learn more about lung cancer treatment at the OSUCCC - James, visit cancer.osu.edu or call 1-800-293-5066.

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Method of Research

Randomized controlled/clinical trial

Subject of Research

People

Betty Paschall, a stage 4 lung cancer survivor, plays with her dog Mocha at their home in Delaware, Ohio.

Psychedelics Could Lessen Depression in Lung Cancer Patients [VIDEO] 

A clinical trial at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is exploring a novel approach to treat mental health struggles in lung cancer patients: psilocybin-assisted therapy.

Credit

The Ohio State University Comprehensive Cancer Center

Early interventions for depression tied to better cancer survival

Large Medicare analysis finds depression was linked to higher cancer mortality, while psychotherapy soon after diagnosis was associated with lower risk

American Society for Radiation Oncology

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BOSTON, September 28, 2026 — Depression may be an overlooked factor in cancer outcomes, according to a large SEER-Medicare analysis of more than 265,000 adults with six common cancers.

Researchers found that patients with major depressive disorder had a higher risk of dying from their cancer, while those who received psychotherapy within four weeks of their cancer diagnosis had a 21% lower risk of cancer-specific mortality. Only 3% of patients with depression received psychotherapy in that early window, however. Results will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting.

“Depression can be easy to miss in cancer care because symptoms such as fatigue, difficulty concentrating and loss of interest often overlap with the effects of cancer or its treatment,” said Edmund M. Qiao, MD, lead study author and a radiation oncology resident at the University of California San Diego. “But when depression goes unrecognized or untreated, it can add another layer of difficulty at a time when patients need support the most. Our findings suggest that earlier screening and referral for psychotherapy could help address an important gap in comprehensive cancer care.”

Depression is common among people with cancer, but mental health services are not always integrated into oncology care. For the current study, researchers sought to understand whether depression itself was associated with cancer mortality and whether outcomes differed according to the type and timing of mental health treatment. The retrospective analysis examined two common approaches to treating depression: psychotherapy and antidepressant medication.

Researchers analyzed records from 265,639 Medicare beneficiaries age 66 or older who were diagnosed from 2010 to 2017 with breast, colorectal, prostate, bladder, kidney or non-small cell lung cancer (NSCLC). More than one in five patients (22%) also had a diagnosis of major depressive disorder.

Psychotherapy was identified through Medicare procedure codes, while pharmacotherapy was identified through Medicare Part D claims for antidepressant medications. Researchers evaluated treatment within four weeks of cancer diagnosis, with additional analyses at eight and 12 weeks.

Patients with both cancer and depression had an 11% higher risk of cancer-specific mortality than those without depression. One year after diagnosis, 29% of patients with depression had died from their cancer, compared with 21% of patients without depression. At five years, cancer-specific mortality was 43% for patients with depression, compared to 35% for those without it.

Psychotherapy soon after cancer diagnosis showed the strongest association with lower cancer mortality among patients with depression. Patients who received psychotherapy within four weeks had a 21% lower risk of cancer-specific mortality in adjusted analyses using propensity score weighting. There were smaller reductions associated with psychotherapy at eight weeks (13% lower risk) and 12 weeks (12% lower risk).

“Patients who connected with psychotherapy earlier tended to have better outcomes than those who did not receive it during that period,” Dr. Qiao said. “For oncology providers, these findings support identifying patients who may need mental health care and connecting them with appropriate services as early as possible.”

Five-year cancer-specific mortality was 31% among patients who received psychotherapy and 44% among those who did not. In this large patient cohort, however, only 3% of patients with depression had a psychotherapy session within four weeks of their cancer diagnosis, growing to just 4.6% by 12 weeks.

Medication was used much more often than psychotherapy, by 32.5% of patients within four weeks of their cancer diagnosis. It was not associated with lower cancer-specific mortality at any of the measured timepoints when analyzing the cohort without accounting for specific cancer type, however.

Researchers also examined associations between mental health, treatment and cancer-specific mortality for each of the six cancer types. Depression was most common among patients with NSCLC (27%) and least common among those with prostate cancer (13%). It was significantly associated with higher cancer-specific mortality in every cancer group, with the strongest association seen in prostate cancer.

The association between psychotherapy and cancer-specific mortality varied by cancer type, reaching statistical significance for prostate, breast and kidney cancer. Pharmacotherapy was significantly associated with lower cancer-specific mortality among patients with prostate cancer.

The differences across cancer types suggest that the relationship between mental health and cancer outcomes may be more nuanced than a single approach to depression management can capture, Dr. Qiao said.

“In the general population, psychotherapy and medication can both be effective ways to manage depression,” he said. “But cancer care adds context. A patient’s cancer type, prognosis and treatment course may influence both their mental health needs and which interventions are most helpful.”

Because the study was retrospective, it cannot establish that psychotherapy caused the reduction in cancer mortality. Although the researchers used statistical methods to account for measured differences between patients who did and did not receive mental health treatment, unmeasured factors could have influenced both access to psychotherapy and cancer outcomes. The analysis also was limited to Medicare beneficiaries, and future research is needed to examine whether similar patterns are seen in younger patients.

“Cancer care has become increasingly personalized, but mental health care in oncology often remains generalized,” Dr. Qiao said. “These findings suggest we need to think more carefully about how depression may affect different types of cancer and how we can work with patients to create individualized support plans early in their care.”

ASTRO Expert Perspective

“Depression is common among people facing cancer, but it is often under recognized and undertreated. This study shows that timely treatment for depression is associated with better cancer survival. Patients who received treatment within 1 month of diagnosis had a lower risk of cancer death; it also shows that psychotherapy may potentially be underutilized given larger benefits over medication. Tailored and appropriate screening and referral for mental health care is an essential part of life-saving oncology care,” said ASTRO expert Fumiko Chino, MD, a radiation oncologist at The University of Texas MD Anderson Cancer Center in Houston.

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This release contains updated study data provided by the authors. Where figures differ from the abstract, please use those reported in this release.

Attribution to the American Society for Radiation Oncology (ASTRO) Annual Meeting is requested in all coverage.

Study & Presentation Details

• Dr. Qiao will discuss this study in a news briefing on Tuesday, Sept. 29; register here.
• Abstract details (available after 5:00pm ET on Sept. 25; embargoed abstract available on request)
• Session details & virtual meeting link
• Dr. Qiao’s bio & disclosures
• Find more information about the meeting in our press kit.

ABOUT ASTRO

The American Society for Radiation Oncology (ASTRO) is the world’s largest professional society dedicated to advancing radiation medicine, with 11,000 members including physicians, nurses, physicists, radiation therapists, dosimetrists and other professionals who work to improve patient outcomes through clinical care, research, education and advocacy. Radiation therapy is integral to 40% of cancer cures worldwide, and more than one million Americans receive radiation treatments for their cancer each year. For information on radiation therapy, visit Speed of Light – The ASTRO Foundation. To learn more about ASTRO, visit our website and press room and connect with us on social media.

 

Can psychedelic clinical trials be better? Researchers say yes

University of California - San Francisco

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UC San Francisco researchers are weighing in on one of the biggest challenges in psychedelic science, arguing that clinical trials need more convincing placebo treatments to better measure the drugs' true effects.

The debate hinges on "masking," the clinical trial gold standard that keeps patients and researchers from knowing who receives the active drug or a placebo. Because psychedelics produce such distinctive effects, participants can almost always tell whether they got the real thing. That makes it hard to separate a drug's effects from the power of expectation, including the disappointment patients feel when they realize they did not receive the psychedelic.

In a perspective published Sept. 16 in JAMA Psychiatry, researchers from UCSF, UC San Diego, and Stanford University call for a more aggressive approach to preserving masking in psychedelic clinical trials. The paper arrives as psychedelic research gains momentum and regulators face growing pressure to decide how these treatments should be evaluated and approved.

Instead of relying on active placebos such as niacin, which can cause flushing but little else resembling a psychedelic experience, the researchers propose carefully designed combinations of approved drugs to create a more convincing placebo. They also recommend limiting what participants are told about the study, making it harder to guess which treatment they received.

Psychedelics for serious mental illness have drawn growing interest because many patients do not respond to existing treatments. The authors argue that if researchers too readily accept failed masking as unavoidable, these compounds will never be rigorously tested.

"People say psychedelics can't be masked, so we should stop trying and just move on, because the effects are so obvious," said Josh D. Woolley, MD, PhD, associate professor in residence of psychiatry and behavioral sciences at UCSF and the paper's senior author. "But medicine has been fooled by obvious effects before. Heart stents for stable chest pain and knee arthroscopy for arthritis both looked effective until sham-controlled trials showed they weren't. We're excited about this paper because it outlines a novel approach that might finally make effective masking possible for psychedelics."

The proposed strategy, called UMBRAA, short for Unidentifiable Multidrug Blinding with Reduced, Authorized Awareness, combines giving carefully selected FDA-approved drugs with limited disclosure to study participants about what drugs they are receiving to make it harder for them to guess whether they are in the active treatment or the placebo-controlled arm of the study.

For example, a placebo might combine drugs from different classes, such as a sedative, a stimulant, and a cannabinoid. The researchers hypothesize that pairing drugs with different effects could create an intense, unfamiliar altered state that is harder to distinguish from psilocybin than current controls.

The researchers acknowledge that UMBRAA raises safety and ethical concerns and would require careful screening, close medical monitoring, and regulatory oversight.

They stress that the framework is a proposal, not a proven method. Future research will need to identify safe drug combinations, test whether they improve masking, and establish appropriate safeguards.

Authors: Other authors include Andrew Krystal, MD, PhD, of UCSF; Kevin H. Yang, MD, of UC San Diego; and Boris D. Heifets, MD, PhD, of Stanford University.

About UCSF: The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. UCSF Health, which serves as UCSF’s primary academic medical system, includes top-ranked specialty hospitals  and other clinical programs, and has affiliations throughout the Bay Area. UCSF School of Medicine also has a regional campus in Fresno. Learn more at ucsf.edu. 

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Journal

JAMA Psychiatry