What Is Psychedelic-Assisted Therapy?

Written by Stephanie Karzon

What’s up with Psychedelic-Assisted Therapy THEN VS RIGHT NOW?

Stephanie Karzon Abrams, Clinical Pharmacologist, Founder Beyond Consulting & GALILEA

Psychedelic-assisted therapy is a mental health treatment in which a person takes a psychedelic or related medicine, such as psilocybin, MDMA, LSD or ketamine, in a supervised clinical setting, with trained clinicians supporting them before, during and after the session. The medicine opens a window. Preparation and integration are what help a person climb through it.

That is the short answer. The long one is older than any of the institutions now racing to approve these medicines.

People have been working with psychoactive plants and fungi for thousands of years, in ceremonies built by Indigenous communities who still hold that knowledge today. Western medicine arrived late, studied these compounds intensely through the 1950s and 1960s, then outlawed them and spent three decades pretending none of it had happened. Now, in late 2026, two psilocybin programs and a methylone program hold federal priority vouchers, an LSD formulation has three positive Phase 3 trials behind it, MDMA is back in front of the FDA, and a handful of U.S. states and countries already let patients access psilocybin legally.

So where does that leave you, if you're curious, struggling, or simply trying to understand what everyone is talking about? This guide covers the whole arc: the Indigenous foundations, the first research era (including the women history forgot), the work happening outside the United States, prohibition, the modern revival, and exactly where the regulatory picture stands right now.


Last updated: October 2026. Psychedelic research and regulation are changing quickly; the status section reflects what was publicly known at the time of writing.

In this guide:

  • How psychedelic-assisted therapy works

  • Which medicines are used

  • Indigenous roots: the people who carried this knowledge first

  • The first research era, 1940s–1970s

  • Prohibition and what was lost

  • The renaissance, 1990s–2020s

  • Where things stand in 2026

  • Risks, who it isn't for, and the access problem

  • Frequently asked questions

How psychedelic-assisted therapy works

Most clinical models move through three phases, and the medicine session is only the middle one.

Preparation

Before any medicine is taken, a clinician screens for medical and psychiatric risks, reviews current medications, and spends time with the person on what they hope to explore. Trust gets built here. So does a shared plan for what happens if the experience turns difficult, because sometimes it does.

The medicine session

The session itself usually takes place in a calm, comfortable room, often with eyeshades and a curated music playlist, with one or two trained facilitators present throughout. Depending on the compound, a session can last under an hour (some ketamine protocols) or a full working day; in Definium's Phase 3 LSD program, participants met end-of-session discharge criteria in an average of 6.4 hours. The facilitator's job is mostly to stay present, keep the person safe, and resist the urge to steer.

Integration

In the days and weeks afterward, the person meets with their clinician to make sense of what surfaced and translate it into change: a conversation they need to have, a pattern they finally see clearly, a grief they can now let move. Many clinicians would argue that integration is where the healing actually consolidates.

Set, setting and why context matters

The outcome of a psychedelic experience depends heavily on "set" (the person's mindset, expectations and history) and "setting" (the physical and social environment). That principle is so central to the field that it's easy to forget someone had to work it out. Several of the people who did were women, and you'll meet them below.

How is this different from taking a psychedelic recreationally?

The molecule can be the same. Nearly everything else differs: medical screening, a known dose of a tested product, trained professionals in the room, a therapeutic intention, and structured follow-up. Those differences change the risk profile considerably, and they are the reason regulators approve treatments rather than substances.

Which medicines are used?

"Psychedelic" is used loosely. The classic psychedelics (psilocybin, LSD, DMT, mescaline) act mainly on the serotonin 2A receptor. Though there is much more to them then their receptor activity and pharmacology, this nomenclatature helps us with classification. MDMA is better described as an entactogen, a compound that increases feelings of connection and lowers fear. It is also often considered and also debated as a psychedelic. We at Beyond, fully believe it is one. Ketamine is a dissociative anesthetic that works on the glutamate system. Ibogaine stands apart again, with a complex pharmacology and real cardiac risk. They get grouped together because they produce non-ordinary states that clinicians can work with therapeutically. They’re all psychedelic at the end of the day. They open your mind, they can reveal the soul and psyche; they can powerfully change your perception.



Medicine Source Main research focus U.S. status, October 2026
Ketamine / esketamine (Spravato) Synthetic Treatment-resistant depression, suicidality Ketamine: FDA-approved anesthetic, used off-label in clinics. Spravato: FDA-approved for treatment-resistant depression since 2019
Psilocybin (COMP360 and others) Mushrooms; synthetic in trials Treatment-resistant and major depression Schedule I. Rolling NDA under review; state-legal programs in Oregon, Colorado, New Mexico
LSD (DT120) Synthetic Generalized anxiety, major depression Schedule I. Three positive Phase 3 trials; NDA planned first half of 2027
MDMA Synthetic PTSD Schedule I. Rejected by FDA in 2024; resubmitted August 2026
Methylone (TSND-201) Synthetic PTSD Investigational; priority voucher awarded April 2026
Ibogaine Iboga root bark (Gabon) Opioid use disorder, traumatic brain injury Schedule I. FDA gathering input on early-stage trial design
Ayahuasca / DMT Amazonian plants Depression, addiction Schedule I, with court-recognized religious exemptions
5-MeO-DMT Toad secretion; synthetic Treatment-resistant depression Schedule I; in mid- and late-stage trials



Ketamine is the only one in this list a U.S. clinician can legally prescribe for mental health today, which is why ketamine-assisted psychotherapy has become the working model many clinics will build on as other medicines arrive.

Indigenous roots: the people who carried this knowledge first

The plant and fungal medicines now moving through Western trials each have a human lineage that predates the laboratory by centuries. Often by millennia. That history is the foundation of the field, and an article that rushes past it is telling the story backwards.

Peyote and the peoples of the Chihuahuan Desert

In 2005, researchers radiocarbon-dated two peyote buttons held at the Witte Museum in San Antonio, believed to come from Shumla Cave No. 5 on the Rio Grande in Texas. The samples dated to 3780–3660 BC, and chemical analysis still found mescaline in both. The authors concluded that the finding strengthens the evidence that Native North Americans recognized peyote's psychotropic properties as long as 5,700 years ago.

The Wixárika (Huichol) people of western Mexico still make pilgrimage to Wirikuta to gather peyote as a sacrament. In the United States, the Native American Church carried peyote ceremony through decades of persecution; after the Supreme Court ruled against two members in Employment Division v. Smith (1990), Congress amended the American Indian Religious Freedom Act in 1994 to protect religious peyote use by Native Americans. Today the cactus itself is under pressure from overharvesting and habitat loss, which is one reason many Indigenous leaders have asked that peyote be left out of decriminalization campaigns.

Psilocybin mushrooms and the Mazatec

The Aztecs called the mushrooms teonanácatl, and Spanish colonizers tried to stamp out their use. The practice survived, quietly, in the mountains of Oaxaca. In 1955 a Mazatec curandera named María Sabina allowed an American banker, R. Gordon Wasson, to take part in a velada, an all-night healing ceremony, in Huautla de Jiménez.


Wasson published his account in Life magazine on May 13, 1957, under the title "Seeking the Magic Mushroom." He changed her name, but not well enough. Outsiders flooded Huautla, many with little respect for Mazatec custom; by several accounts Sabina was ostracized, her home was burned, and she later regretted sharing the ceremony. She died in poverty in 1985. Indigenous scholars have described the episode as a story of extraction and cultural appropriation, and it remains the clearest warning the field has about what happens when knowledge is taken without reciprocity.

Read that last part twice.

The mushrooms Wasson's team collected went to Albert Hofmann at Sandoz, who isolated psilocybin and psilocin in 1958. Every psilocybin trial running today traces back to that ceremony in Oaxaca.

Ayahuasca and the Amazon

Ayahuasca, a brew typically made from the Banisteriopsis caapi vine and DMT-containing leaves, is central to the healing traditions of many Amazonian peoples, including the Shipibo-Konibo of Peru. In 2008 Peru declared the traditional use of ayahuasca part of its national cultural heritage. Brazilian religions that formed around the brew, such as Santo Daime and the União do Vegetal (UDV), later carried it abroad, and in 2006 the U.S. Supreme Court ruled unanimously in Gonzales v. O Centro Espírita that the UDV could use it in worship under the Religious Freedom Restoration Act.

Iboga and the Bwiti of Gabon

In Gabon, the root bark of Tabernanthe iboga sits at the heart of Bwiti initiation, a tradition practiced across many of the country's ethnic communities. Ibogaine, the alkaloid extracted from it, is now attracting state money in Texas, federal attention in Washington, and interest from Eli Lilly. Gabon has responded with law: a 2026 decree requires benefit-sharing agreements for commercial use of iboga and the traditional knowledge around it, with royalties to flow into a national fund shared with source communities, and in September the government moved to halt iboga exports while it builds a new national framework. Gabon is a party to the Nagoya Protocol on access and benefit-sharing. The United States is not.

Reciprocity is part of the history

When a clinic in Los Angeles or a pharmaceutical company in London profits from medicines that Indigenous communities protected for generations, those communities rarely see any of it. Organizations such as the Indigenous Peyote Conservation Initiative, Chacruna's Indigenous Reciprocity Initiative of the Americas, and Blessings of the Forest in Gabon are trying to change that. Any honest account of psychedelic therapy has to hold both truths at once: these medicines may help millions of people, and the path that brought them here was often taken without permission.

The first research era, 1940s–1970s

On April 16, 1943, Swiss chemist Albert Hofmann accidentally absorbed a small amount of a compound he had first synthesized at Sandoz in 1938: lysergic acid diethylamide, LSD-25. Three days later he took a deliberate dose and rode his bicycle home through Basel. Sandoz soon began supplying LSD to researchers under the brand name Delysid, and for the next two decades psychiatry treated it as one of the most promising tools it had.

The scale is easy to underestimate. Between 1950 and 1965, some 40,000 patients received some form of LSD therapy, and the research produced more than 1,000 scientific papers and six international conferences.

Saskatchewan: where the word "psychedelic" was born

In 1951, British psychiatrist Humphry Osmond took a post at the Weyburn Mental Hospital in Saskatchewan, Canada, and began working with psychiatrist and biochemist Abram Hoffer. In 1953 they gave single large doses of LSD to patients with alcoholism. Osmond and Hoffer reported that 40% to 45% of the alcoholics treated with LSD had not relapsed after a year; those early studies lacked the controls modern trials require, and later controlled work produced more mixed results. In correspondence with Aldous Huxley, Osmond coined the word "psychedelic," meaning mind-manifesting, and presented it at the New York Academy of Sciences in 1957.


Saskatchewan was also where nurses were trained to sit with patients through frightening hallucinations and offer empathy rather than restraint. That small, unglamorous change in practice is one of the true origins of the modern facilitator.

Some of the women who wrote "set and setting" into the field

The standard history of this era is a parade of men: Hofmann, Osmond, Hoffer, Sidney Cohen, Timothy Leary. The people who shaped how psychedelic therapy is actually delivered include several women whose names rarely appear.

Betty Eisner (1915–2004) was a psychologist who began working with Sidney Cohen at the Veterans Administration in Los Angeles in 1955, first as his research subject and then as a researcher. She conducted early studies using LSD to treat alcoholism, worked on the question with Bill W., the co-founder of Alcoholics Anonymous, and helped develop the ideas we now call set and setting. Late in life she proposed adding a third element, the "matrix," for the wider environment a person returns to. When she died, she received no New York Times obituary. Cohen did.


Margot Cutner (1905–1987), a Jungian psychoanalyst who fled Nazi Germany for England, joined Ronald Sandison's LSD unit at Powick Hospital in Worcester in 1955. She trained in body therapy, paid close attention to the patient's physical comfort, and observed in 1959 that the material emerging under LSD was far from chaotic; it related to the patient's psychological needs at that moment.


Joyce Martin (1905–1969), a Freudian psychoanalyst in London, began LSD work in 1954 at the Marlborough Day Hospital. With her colleague Pauline McCririck she developed "fusion" therapy for patients who had suffered severe maternal deprivation, physically holding them during sessions. It was controversial then and would be outside ethical bounds now, yet it was an early, serious attempt to treat relational wounds through presence rather than interpretation. Historian Zoë Dubus notes that these women also insisted, early on, that LSD was not for everyone and that patients had to be selected carefully, which is exactly how modern screening works.

Dr. Valentina Pavlovna Wasson (1901–1958), a Moscow-born pediatrician and mycologist, is usually remembered as Gordon Wasson's wife. She was the one who loved mushrooms first. She co-authored Mushrooms, Russia and History (1957), and six days after her husband's Life article she published her own account, "I Ate the Sacred Mushroom," in This Week, a Sunday supplement with a circulation in the millions. She died of cancer the following year.

Thelma Moss, writing under the pseudonym Constance A. Newland, published My Self and I in 1962, a bestselling first-person account of 23 LSD psychotherapy sessions. For many readers it was their first look inside the therapy room. Moss later earned a PhD and joined the faculty at UCLA.

Key historical figures, pioneers, and subjects highlighted across the collection and related Chacruna Institute pieces include:

  • Susi Ramstein – Albert Hofmann’s lab assistant and the first woman to take LSD.

  • Mrs. Amanda Cardenas – The first female peyote dealer in the United States.

  • María Sabina – Renowned Mazatec shaman who introduced magic mushrooms to Western consciousness.

  • Mabel Dodge Luhan – Socialite and writer who provided early Western accounts of peyote ceremonies.

  • Maria Nys Huxley – Aldous Huxley’s first wife.

  • Laura Archera Huxley – Aldous Huxley’s second wife, therapist, writer, and founder of a human-potential organization.

  • Rosemary Woodruff Leary – Partner of Timothy Leary, known for helping him break out of jail.

  • Dr. Florence Nichols – Canadian psychiatrist and Christian missionary.

  • Kay Parley – Writer and patient whose experiences with LSD gave insight into psychosis.

  • Ann Shulgin – Co-author of PIHKAL and TIHKAL and pioneer of Jungian psychedelic-assisted therapy.

  • Betty Eisner – Psychologist who researched LSD for alcoholism and co-developed early therapy guides.

  • Rose Hoffer – Researcher spouse who ingested 1950s LSD alongside her husband Abram Hoffer.

  • Valentina Pavlovna Wasson – Physician and researcher whose early mushroom work was often overshadowed by her husband, R. Gordon Wasson.

  • Mary Barnard – Poet and translator who wrote lyrical accounts of early psychedelic experiences.

  • Gertrude Paltin – Early female therapist and author in psychedelic history. [1, 2, 3, 4]

Outside the United States

Much of the most systematic clinical work happened in Europe, where therapists favored a "psycholytic" model: lower doses of LSD or psilocybin, repeated over many sessions, inside psychoanalytic therapy. The American and Canadian "psychedelic" model used one or a few high doses aimed at a transformative experience.

In the United Kingdom, Ronald Sandison's unit at Powick Hospital opened in the mid-1950s and was one of the first purpose-built LSD therapy departments anywhere. In Germany, Hanscarl Leuner at the University of Göttingen organized the First European Symposium for Psychotherapy under LSD-25 in 1960, which led to the European Medical Society for Psycholytic Therapy in 1964; psycholytic therapy was eventually practiced at around 30 clinical centers and by more than 100 outpatient psychotherapists across the continent.


In Czechoslovakia, psychiatrist Stanislav Grof ran LSD research in Prague through the 1960s before moving to the United States, where he continued at the Maryland Psychiatric Research Center (Spring Grove). In the Netherlands, Jan Bastiaans began using LSD and psilocybin in 1961 to treat survivors of Nazi concentration camps, a condition he called the "KZ syndrome." As a professor at Leiden University, he treated hundreds of traumatized war survivors, which makes his clinic one of the earliest places psychedelics were used for what we now call PTSD.


Back in the U.S., the Spring Grove team studied LSD for alcoholism and for distress in people with terminal cancer, and Walter Pahnke's 1962 Good Friday Experiment at Boston University's Marsh Chapel tested whether psilocybin could occasion mystical experience. Those two threads, addiction and end-of-life distress, are exactly where the modern revival picked up.

Prohibition and what was lost

By the early 1960s, LSD had escaped the clinic. Harvard dismissed Timothy Leary and Richard Alpert in 1963, the drug became a symbol of the counterculture and the antiwar movement, and the political mood turned hard and fast. The 1962 Kefauver-Harris Amendments had already tightened the rules for investigational drugs. Sandoz stopped distributing LSD in 1966. Federal law criminalized LSD possession in 1968.

Then came the two laws that still define the field. The U.S. Controlled Substances Act of 1970 placed LSD, psilocybin, mescaline and DMT in Schedule I, the category for drugs with "no currently accepted medical use" and a high potential for abuse. The 1971 United Nations Convention on Psychotropic Substances carried similar controls around the world. Research did not become technically impossible, but funding, licenses and institutional appetite evaporated almost overnight.

A few doors stayed open. Leuner kept his license in Göttingen until he retired in 1986, and Bastiaans treated war survivors in Leiden into the 1980s. In the United States, a small underground of therapists, among them Leo Zeff in California and Ann Shulgin, a lay therapist who was also the chemist Alexander Shulgin's wife and collaborator, used MDMA in therapy through the late 1970s and early 1980s while it was still legal. The Drug Enforcement Administration placed MDMA in Schedule I on an emergency basis in 1985. The following year, Rick Doblin founded the Multidisciplinary Association for Psychedelic Studies (MAPS) in direct response.

What was lost is hard to measure. Thousands of patients who might have been helped were not, a generation of clinicians never trained, and a body of research was left to gather dust because it was easier to forget than to defend.

The renaissance, 1990s–2020s

The revival started small. In 1990, psychiatrist Rick Strassman at the University of New Mexico received approval to give DMT to human volunteers, the first new U.S. study of a classic psychedelic in roughly two decades. In 1998, Amanda Feilding founded the Beckley Foundation in the United Kingdom, which went on to co-fund much of the early brain-imaging work at Imperial College London.

The paper that changed the field's trajectory came in 2006, when Roland Griffiths and colleagues at Johns Hopkins published a double-blind study in which psilocybin occasioned mystical-type experiences that volunteers rated among the most meaningful of their lives. Hopkins, NYU and UCLA then ran trials in people with cancer-related anxiety and depression, deliberately echoing the Spring Grove work of the 1960s.


From there the research widened quickly:

  • Imperial College London, under Robin Carhart-Harris and David Nutt, ran psilocybin trials in treatment-resistant depression and, in 2021, a head-to-head trial against the antidepressant escitalopram published in the New England Journal of Medicine. Psilocybin did not beat escitalopram on the trial's primary depression measure, though several secondary measures favored psilocybin. Rosalind Watts, a clinical psychologist on those trials, developed the ACE (Accept, Connect, Embody) model that shaped how many therapists now think about integration.

  • MAPS ran Phase 3 trials of MDMA-assisted therapy for PTSD; the first, led by Jennifer Mitchell, was published in Nature Medicine in 2021. Rachel Yehuda, a leading trauma researcher, founded the Center for Psychedelic Psychotherapy and Trauma Research at Mount Sinai in New York.

  • Compass Pathways published a Phase 2b trial of its synthetic psilocybin, COMP360, in the New England Journal of Medicine in 2022, then launched the Phase 3 program that is now under FDA review.

  • In March 2019, the FDA approved Johnson & Johnson's esketamine nasal spray, Spravato, for treatment-resistant depression, the first new mechanism for depression in decades and the first psychedelic-adjacent medicine to reach U.S. pharmacies and clinics.


The revival also inherited the old era's blind spots. Studies have consistently found that participants in psychedelic trials are overwhelmingly white, and critics, including many Indigenous and BIPOC practitioners, have asked who these medicines are really being developed for. Bia Labate, an anthropologist who founded the Chacruna Institute, has spent years pushing the field to reckon with that question, and with the colonial history it rests on.

The momentum hit its first big wall in August 2024, when the FDA declined to approve MDMA-assisted therapy for PTSD. An advisory committee had voted against it earlier that summer, citing concerns about functional unblinding (participants usually know whether they received the drug), incomplete safety data, and conduct issues in the trials. The agency asked for an additional Phase 3 trial. Three related papers were retracted days later. Many in the field read the rejection as the end of an era of optimism. It turned out to be a pause.

Where psychedelic-assisted therapy stands in 2026

As of October 2026, no classic psychedelic is FDA-approved, but the first approval decisions could come within months. This section reflects the public record as of late October 2026, and it will not stay current for long. Research in this field is moving faster than at any point since the 1960s: trial results, FDA decisions, DEA scheduling, state laws and international frameworks are all shifting month to month, sometimes week to week. Treat every timeline below as a company's or agency's stated expectation at the time of writing, not a guarantee. We update this page as things change, so check the date at the top before you rely on it.

Federal policy: an executive order and priority vouchers

On April 18, 2026, President Trump signed Executive Order 14401, Accelerating Medical Treatments for Serious Mental Illness. It directs the FDA to give Commissioner's National Priority Vouchers to appropriate psychedelic drugs that hold Breakthrough Therapy designation, directs the FDA and DEA to create a pathway for patients to access investigational psychedelics, ibogaine included, under the federal Right to Try Act, and commits $50 million to support state research, with ibogaine as a priority.

Six days later, on April 24, the FDA issued vouchers to three programs: Compass Pathways (COMP360 psilocybin for treatment-resistant depression), the nonprofit Usona Institute (psilocybin for major depressive disorder) and Transcend Therapeutics (methylone for PTSD). The vouchers aim to shorten FDA review to roughly one to two months after a complete application is filed. In July, the FDA finalized its guidance Psychedelic Drugs: Considerations for Clinical Investigations, first issued in draft in 2023. It held a public hearing on the therapeutic use of psychedelics in September, with written comments closing October 5.

The executive order has critics as well as supporters. Legal scholars have pointed out that ibogaine, with its known cardiac risks, is arguably the psychedelic least likely to meet the basic safety requirements of the Right to Try Act, and that an executive order's power to change drug policy has limits.

Psilocybin: COMP360 is first in line

Compass Pathways reported positive results from two Phase 3 trials of COMP360 in treatment-resistant depression (COMP005 and COMP006), including 26-week data showing a durable effect. Its rolling New Drug Application is under FDA review, with the final submission expected in the fourth quarter of 2026 and a U.S. launch anticipated in the first half of 2027, subject to FDA approval and DEA rescheduling. Psilocybin remains Schedule I until the DEA acts.

Usona's Phase 3 uAspire trial in major depressive disorder has finished enrolling; results had not been publicly announced as of this writing.

LSD: three Phase 3 wins in one year

Definium Therapeutics (formerly MindMed) has now reported three positive Phase 3 trials of DT120, its orally disintegrating LSD tablet. Emerge, in major depressive disorder, read out in June 2026. Voyage, in generalized anxiety disorder, followed in August: in 214 adults, a single 100 µg dose reduced anxiety scores by 11.6 points at week 12, versus 6.2 for placebo. Panorama, a second anxiety trial that added a 50 µg arm to address the unblinding problem, was positive in September. Definium has a pre-NDA meeting scheduled for late 2026 and plans to file in the first half of 2027.

MDMA: back at the FDA

On August 9, 2026, Resilient Pharmaceuticals (formerly MAPS PBC, then Lykos Therapeutics) resubmitted its application for MDMA-assisted therapy for PTSD, without the new Phase 3 trial the FDA had requested in 2024. A resubmission is not an acceptance or an approval; the FDA first decides whether to review it.

Ibogaine: the most political medicine…crazy right?!

Texas passed Senate Bill 2308 in June 2025, committing $50 million to ibogaine clinical trials in exchange for a share of any future revenue. When no drug company met the state's terms, Texas leaders announced in March 2026 that the state would run its own research program. In October, the FDA published a request for information on early-stage ibogaine trials, and MAPS reports that at least ten states are now backing ibogaine research.

The VA is preparing

The Veterans Health Administration has selected ten sites to deliver psychedelic therapies once a drug is approved, and federal officials have described those sites as being ready to begin care as early as January or February 2027 if an approval comes through.

State programs

Three states have built legal frameworks for psilocybin outside the FDA process. Oregon's psilocybin service centers opened in 2023; Colorado's Natural Medicine program, which also covers other plant medicines, began serving clients in 2025; and New Mexico's Medical Psilocybin Program is expected to launch in December 2026, a year ahead of its statutory deadline. Across Oregon and Colorado, more than 15,000 people have already received legal, regulated psilocybin services. The programs are fragile: Oregon is facing a $3.8 million shortfall after dropping a planned fee increase, and services are not covered by insurance.

At least 23 states have introduced psychedelic legislation in 2026, and five have enacted "trigger laws" designed to streamline psilocybin access once the FDA approves it.

Around the world

Country What's legal Since
Australia Authorised psychiatrists may prescribe MDMA for PTSD and psilocybin for treatment-resistant depression July 2023
Canada Case-by-case access through Health Canada's Special Access Program 2022
Switzerland Limited medical use by authorized psychiatrists, one of the longest-running programs in the world 2014
New Zealand Psilocybin approved for treatment-resistant depression under a named psychiatrist June 2025
Germany Compassionate-use psilocybin for treatment-resistant depression at authorized centers 2025
Czech Republic Trained psychiatrists may administer psilocybin in authorized healthcare settings January 2026

Australia was the first country to reschedule MDMA and psilocybin for medical use, yet uptake has been slow: roughly 87 patients had received MDMA-assisted therapy and 47 psilocybin-assisted therapy as at September 2025, even though more than 600 therapists had trained. A legal pathway, it turns out, is only the first step. In Europe, the Czech law limits psilocybin to cancer-related depression, serious depression without psychotic symptoms, and life-threatening mental states when registered treatments have failed.

Risks, who it isn't for, and the access problem

Psychedelic-assisted therapy is not a gentle wellness ritual, and it is not for everyone. In a medical setting with proper screening, the classic psychedelics have a relatively favorable physical safety profile, but the risks are real.

People with a personal or family history of psychosis, schizophrenia or bipolar I disorder are usually excluded from trials, because these medicines can trigger or worsen psychotic symptoms. MDMA raises heart rate and blood pressure, and ibogaine can disrupt the heart's electrical rhythm in ways that have caused deaths. Drug interactions matter: lithium combined with classic psychedelics has been linked to seizures, and ayahuasca contains MAO inhibitors that interact dangerously with many antidepressants. Many people currently on SSRIs also find their response to psilocybin blunted.

The psychological risks deserve the same honesty. A session can bring up overwhelming fear, grief or traumatic memory. People are at their most suggestible and vulnerable while under these medicines, and the field has documented cases of therapist boundary violations, including during clinical trials. Who is in the room, and how they were trained and supervised, may matter as much as the molecule.

Then there is the question of who gets access. Treatment-resistant depression already has an FDA-approved option in Spravato, and Compass executives have suggested COMP360's annual cost could be broadly comparable to Spravato's $50,000–$65,000 range. State psilocybin programs are paid out of pocket. Rural communities, people of color, and Indigenous communities whose ancestors stewarded these medicines are the least likely to reach them. If the next decade simply builds an expensive clinic model for people who can already afford excellent care, the field will have repeated its oldest mistake in a new building.

Frequently asked questions

Is psychedelic-assisted therapy legal in the United States?

Partly. Ketamine can be prescribed off-label, and esketamine (Spravato) is FDA-approved for treatment-resistant depression. Psilocybin is available legally through state programs in Oregon and Colorado, with New Mexico's medical program expected to launch in December 2026. Psilocybin, LSD and MDMA all remain Schedule I under federal law and are otherwise available only in clinical trials.

When will psilocybin therapy be FDA-approved?

As of October 2026, no date is set. Compass Pathways expects to complete its New Drug Application for COMP360 in the fourth quarter of 2026 and anticipates a U.S. launch in the first half of 2027, subject to FDA approval and DEA rescheduling.

What is the difference between psychedelic therapy and ketamine therapy?

Ketamine is a dissociative anesthetic that acts on the glutamate system, while classic psychedelics such as psilocybin act mainly on serotonin 2A receptors. Ketamine sessions are usually shorter, often require repeated treatments, and are legal to offer today. Both are typically delivered with preparation and integration support.

Was MDMA-assisted therapy approved?

Not yet. The FDA declined to approve it in August 2024 and asked for another Phase 3 trial. In August 2026, Resilient Pharmaceuticals resubmitted its application without a new trial, and as of October 2026 the FDA has not announced a decision.

Who should not have psychedelic-assisted therapy?

People with a personal or family history of psychosis or bipolar I disorder, certain heart conditions, or medications that interact dangerously (lithium, and MAO inhibitors in the case of ayahuasca) are generally not good candidates. A qualified clinician should screen every person individually.

Did women play a role in early psychedelic research?

YES OF COURSE and their contributions have long been overlooked.

Where did psychedelic therapy come from?

Indigenous peoples across the world used psychoactive plants and fungi in ceremony and healing for centuries/ Western clinical research began after Albert Hofmann discovered LSD's effects in 1943, flourished in North America and Europe in the 1950s and 1960s, and stopped under prohibition in 1970–71 before restarting in the 1990s.

Building a clinic for what comes next

The first FDA approvals will not arrive in an empty landscape. They will land in clinics that already know how to screen carefully, staff a six-hour session, hold someone through a hard experience, and do integration well. Ketamine-assisted therapy is where most of those skills are being built right now.

Beyond Consulting helps founders and clinical teams launch and operationalize ketamine, psilocybin and integrative medicine centers and clinics, and prepare them for the next generation of treatments—Psilocybin, LSD, and MDMA— now in the FDA pipeline. If you're building toward that future, let's talk.

Sources

Indigenous history


First research era


Current status, 2026

Stephanie Karzon
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