Psychedelics in Therapy – The Next Generation of Treatment
Last reviewed and updated: June 26, 2026.
Key Takeaways
| Ketamine | NOW — 700+ clinics, Spravato FDA-approved for TRD, $400M+/quarter; not “next generation” — it is current standard of care for treatment-resistant depression |
| Psilocybin | Very near — Compass rolling NDA, Usona Phase 3 enrolled; FDA approval outlook 2027–2028; legal now in Oregon (300+ facilitators) and Colorado |
| LSD/DT120 | Phase 3 positive June 2026; FDA submission pending; first positive Phase 3 for LSD in psychiatric indication |
| MDMA | Setback — FDA rejected Lykos NDA in 2024 (functional unblinding, scale issues); reworking methodology; path forward being designed; timeline pushed back |
| Therapist training | Formal infrastructure now exists: MAPS, Fluence, Naropa, Oregon/Colorado state programs — a credentialed psychedelic therapy workforce is being built |
With dozens of clinical trials underway, psychedelics are now viewed as the next best treatment for mental health disorders like depression, anxiety and PTSD. But at the heart of using psychedelics in therapy are their practitioners. The specialized counselors and therapists capable of leading patients into their healing path with drugs like psilocybin, MDMA or LSD.
The promise behind the therapeutic potential of psychedelics is grand. And many therapists are eager to begin applying these drugs in their practice. As of now, some companies and institutions already offer training courses teaching therapists how to work with psychedelics. But the legal landscape is in development, and possibilities to work legally with these drugs are still limited.
Here’s everything you need to know if you want to use psychedelics in therapy today.
From Ceremonial Plants To Scheduled Substances
Psychedelics are psychoactive drugs capable of producing non-ordinary states of consciousness. Their effect can vary depending on the compound, dosage and the person using them. But in general they’re understood to produce feelings of euphoria, hallucinations and abnormal thinking patterns often leading to introspection.
Archeological research has found evidence for the human use of psychedelic substances that dates back to eight thousand years ago. Psychedelics have returned to the public conversation for their ability to treat a wide array of mental health conditions.
The promise of psychedelic drug’s healing potential has become crucial. Especially as we face a global mental health crisis.
And satisfactory solutions for some ailments (like treatment-resistant depression) are still to be found.
Psychedelics got an early moment of glory for western society between the 1940s and the 1960s. In those two decades psychiatrists began experimenting with the therapeutic potential of these drugs. Mostly due to the chemical discovery of LSD in 1938. And the botanical rediscovery of magic mushrooms (containing the psychedelic compound psilocybin) in 1955.
And Then…Sitgma Happened
However, these compounds and others became adopted by the youth culture of the 1960s and 1970s. Which gave them more awareness, but also brought along a growing stigma and backlash. They were seen as purely recreational. And only something that “lazy hippies” took. Because of this, governments quickly shut down access to these drugs. And they stopped being studied when they highly prohibited substances whose use or possession could lead to years in prison.
In the early 2000s, researchers from various universities began revisiting the literature. They were looking into the forgotten potential of these substances in the treatment of mental health conditions.
Today, a wide array of clinical trials are underway, exploring the use of psychedelic drugs in various mental health indications. Some forms of psychedelic therapy are already available in certain countries and jurisdictions in North America. But there are varying degrees of legality.
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Are Psychedelics Legal To Be Used in Therapy?
After the 1971 Convention on Psychotropic Substances by the UN, most psychedelic drugs became Schedule 1 substances across the globe. And this status remains active to this day in almost every country on earth.
Except for very specific exemptions, the use and possession of psychedelics like LSD (Lysergic acid diethylamide), psilocybin, DMT (N,N-Dimethyltryptamine), mescaline and MDMA (3,4-Methylenedioxymethamphetamine), as well as many others, is a serious crime. And often punishable with the full extent of the law. This is true in the United States, Canada, the UK, Australia and other English-speaking countries.
Exemptions include:
- Specific countries where some psychedelics have been decriminalized.
- Jamaica or the Netherlands (where possession of certain forms of psilocybe mushrooms are not enforced by the law).
- Brazil and Costa Rica (where DMT-containing ayahuasca is considered legal).
- Some jurisdictions and municipalities within the U.S. where naturally-produced forms of psychedelic compounds have been made a lowest-level law enforcement priority by city councils. These include Oakland and Santa Cruz in California, Denver in Colorado, Ann Arbor and Detroit in Michigan, Seattle in Washington State and the District of Columbia, among others.
- In the context of clinical trials, where these compounds can be used in an authorized therapeutic setting with the goal of obtaining approval by government regulatory bodies like the U.S. Food and Drug Administration and the European Medicines Agency.
Due to the current illegal status of these drugs, psychedelics-assisted therapy is not a widespread practice in mainstream medicine. And it is only offered within these exceptions.
Outside of clinical trials, the use of psychedelics is not supervised by any regulatory body. This “legal grey area” can sometimes lead to informal or ceremonial applications that lack the medical protocols. And these medical protocols can sometimes be necessary to guarantee a safe and responsible use in psychiatry.
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Ketamine: The Exemption To The Rule
Ketamine is a dissociative drug first synthesized in 1956 and approved by the FDA as an anesthetic. It has gained traction in recent years for its potential in treating some mental health conditions like depression and acute suicidality.
Scientists discovered that patients that received ketamine in their surgical treatments experienced a drop in depression symptoms. As a result, some doctors in the 1990s began prescribing ketamine in an off-label capacity to patients with depression.
In the last decade the practice became widespread. Dozens of clinics opening up in the U.S., offering ketamine in IV, sublingual or intranasal form, with or without psychotherapy.
Scientists don’t yet know if the beneficial effects of ketamine are linked to its psychedelic-like properties. Or if it is purely related to the neurological modulations that the drug is able to produce in the brain. Ketamine’s antidepressant effects usually only last a few weeks. And some clinics and physicians are using the drug in psychotherapy as part of a more holistic approach to healing. Which is called “ketamine-assisted psychotherapy,” or KAP for short.
The use of ketamine in this context is considered legal if prescribed by an MD. Although the drug is prescribed off-label, which are indications that lay outside of the ones officially approved by the FDA.
Which Psychedelics Are Being Studied For Use Therapy?
Psilocybin and MDMA are the two most widely researched psychedelic compounds to this date. Psilocybin is the active ingredient in so-called “magic mushrooms.” And MDMA is known in the party scene as ecstasy or molly.
MDMA has undergone extensive clinical research in a program lead by The Multidisciplinary Association For Psychedelic Studies. They are currently leading the last tranche of a phase 3 clinical trial for the treatment of post-traumatic stress disorder (or PTSD). And so far have seen very promising results.
After analyzing data from the first tranche of their phase 3 trial, The Multidisciplinary Association For Psychedelic Studies researchers found that 67 percent of participants who received three MDMA-assisted therapy sessions for severe PTSD no longer qualified for a PTSD diagnosis by the end of the trial.
This program is generally expected to receive approval by the FDA in 2023.
Psilocybin is expected to follow a similar path, possibly gaining approval by around 2025. A phase 3 trial with the drug is in its early stages after Compass Pathways. Compass is a biotech company that completed a phase 2 trial for treatment-resistant depression.
A plethora of other psychedelic molecules are also being studied in similar clinical trials. These include chemically modified versions of the compounds mentioned above, as well as LSD, DMT, ibogaine and mescaline. And have been studied for indications that include alcohol use disorder, substance abuse, major depression and various forms of anxiety.
Psychedelic Therapy in 2026: No Longer Next-Generation — For Ketamine, It’s Now
When this article was first written, psychedelic-assisted therapy was genuinely “next generation” — promising, scientifically credible, but still years away from broad clinical access. That framing no longer reflects where the field stands in 2026. For ketamine, psychedelic-assisted therapy is not a future development: it is mainstream medicine, practiced in over 700 clinics across the United States and generating over $400 million per quarter in revenue from Spravato (esketamine nasal spray) alone. For psilocybin, FDA approval is a matter of when rather than if, with multiple Phase 3 trials positive and a rolling NDA in progress. The field has undergone a fundamental transition, and patients making decisions today deserve an accurate picture of what is available now versus what is still in development.
The psilocybin approval timeline is now concrete, not speculative. Compass Pathways has reported positive Phase 3 results for COMP360 (synthetic psilocybin 25mg) in treatment-resistant depression and is pursuing a rolling NDA with the FDA — the most advanced regulatory package for a classical psychedelic in history. Usona Institute has its Phase 3 trial for psilocybin in major depressive disorder fully enrolled. Industry analysts and regulatory experts widely project first FDA approval in the 2027–2028 window, though regulatory timelines can shift. The approval, when it comes, will require a REMS (Risk Evaluation and Mitigation Strategy) program specifying that psilocybin be administered in certified facilities by trained practitioners — meaning the infrastructure for psilocybin therapy will look more like Spravato’s current clinic model than like a general outpatient prescription. In the meantime, Oregon has become the first state to operationalize legal psilocybin services under Measure 109, with over 300 licensed facilitators active as of 2026. Colorado is actively certifying facilitators under Proposition 122. These state programs represent legal access to psilocybin therapy now, outside the clinical trial context.
LSD has had a significant 2026 milestone; MDMA faced a major setback. Definium Medicines’ DT120 (a proprietary LSD formulation) reported positive Phase 3 results in June 2026, representing the first positive Phase 3 trial for LSD in a psychiatric indication. An FDA submission is anticipated, potentially adding LSD to the near-term approval pipeline. MDMA-assisted therapy had a significant setback in 2024 when the FDA rejected Lykos Therapeutics’ NDA for MDMA-assisted therapy for PTSD — citing functional unblinding (participants could reliably tell whether they received MDMA), scale reliability issues, and concerns about the therapy model’s trainability. Lykos and the broader MDMA research community are redesigning the trial methodology to address these concerns; a resubmission is planned, but the timeline for MDMA approval has been pushed back significantly from the 2024 expectations. It remains a compelling therapeutic candidate, but the path to FDA approval now requires additional trial work that may take several years.
Therapist training infrastructure now exists at scale. One of the most important changes since this article was written is the emergence of formal therapist training programs that have credentialed hundreds of practitioners. MAPS (Multidisciplinary Association for Psychedelic Studies) has trained therapists through its MDMA protocol training program. Fluence, one of the largest psychedelic therapy training organizations, offers certificate programs in psilocybin, MDMA, and ketamine-assisted therapy used by hundreds of licensed clinicians. Naropa University and other academic institutions offer graduate-level programs in psychedelic therapy. Oregon’s facilitator training requirements under Measure 109 have established a state-certified training pathway. This training infrastructure means that when psilocybin receives FDA approval, there will be a credentialed workforce ready to deliver it — a critical difference from the pre-clinical trial era when “psychedelic therapy” meant underground practitioners. The field is building toward a future where trained psychedelic therapists are a recognized clinical specialty, not a fringe category.
Frequently Asked Questions
What is psychedelic-assisted therapy and how is it different from regular therapy?
Psychedelic-assisted therapy (PAT) combines the pharmacological action of a psychedelic compound with structured psychotherapeutic support before, during, and after the drug session. It is categorically different from both conventional pharmacotherapy (where a medication is taken daily with no specific therapeutic context) and conventional psychotherapy (where a therapist and patient talk without pharmacological augmentation). In PAT, the drug session itself is the therapeutic event — the psychedelic creates a neurobiological window of enhanced neuroplasticity, increased emotional access, and altered self-referential processing during which carefully structured therapeutic work (preparation, the session itself, and integration afterward) can produce changes that persist long after the drug has cleared the system. The therapist’s role during a session varies by compound and protocol: in MDMA-assisted therapy, therapists actively guide emotional processing; in psilocybin therapy, the approach is often more non-directive, allowing the patient’s inner experience to unfold with therapist support but without leading. The “set and setting” (mindset and physical environment) are treated as active therapeutic variables, not background factors.
Which psychedelics are currently approved for therapeutic use?
As of mid-2026: Ketamine/esketamine is the only FDA-approved psychedelic-class compound for psychiatric use. Ketamine infusions are used off-label for treatment-resistant depression by over 700 clinics in the U.S. Spravato (esketamine nasal spray) received FDA approval in 2019 for treatment-resistant depression and in 2020 for major depressive disorder with acute suicidality; it generates over $400 million per quarter in revenue — mainstream medicine, not experimental. Psilocybin: FDA-approved in Oregon and Colorado at the state level under state-specific programs; federal FDA approval is anticipated 2027–2028 (Compass rolling NDA in progress, Usona Phase 3 enrolled). LSD (DT120): Phase 3 positive June 2026; FDA submission anticipated; not yet approved. MDMA: FDA rejected the 2024 NDA; reworking in progress; timeline uncertain but likely several years. No other psychedelics have reached Phase 3 in the U.S. as of this writing. Psilocybin therapy is legally available now in Oregon and Colorado without FDA approval under state frameworks.
How do I find a trained psychedelic therapist?
For ketamine: Any licensed psychiatrist, anesthesiologist, or nurse practitioner at a ketamine clinic can prescribe/administer ketamine; Spravato is available at hundreds of certified REMS clinics. Therapist training varies by clinic. For psilocybin in Oregon: The Oregon Health Authority maintains a registry of licensed psilocybin facilitators (healingorb.com is one directory); facilitators must complete an OHA-approved training program and pass a licensing exam. For psilocybin in Colorado: DORA (Department of Regulatory Agencies) is licensing facilitators under Proposition 122; search the DORA registry. For MDMA and psilocybin clinical trials: ClinicalTrials.gov lists all active trials with enrollment criteria. Training programs for clinicians include Fluence (psilocybin, ketamine, MDMA certificate programs), MAPS training (MDMA protocol-specific), and Naropa University (graduate-level). When evaluating a provider: ask about their specific training, the preparation and integration support they offer, and whether they operate within or outside of clinical trial frameworks. Avoid any provider offering psychedelic therapy without a thorough medical screening process.
Is psychedelic therapy covered by insurance?
Coverage is limited but expanding. Spravato (esketamine) is the most covered psychedelic-class treatment: because it is FDA-approved for TRD and MDD with suicidality, many commercial insurers and Medicare/Medicaid cover it, though prior authorization requirements are common and coverage gaps persist. Ketamine infusions are generally not covered by insurance because they are used off-label; costs typically range from $400–$800 per infusion, with an initial series of 6 infusions recommended. Some HSA/FSA accounts can be used. A small number of progressive insurers are beginning to cover ketamine infusions; check with your insurer directly. Psilocybin therapy in Oregon and Colorado is not currently covered by insurance — the state programs operate outside the FDA approval framework, and insurance coverage generally follows FDA approval. Oregon session costs range from $800–$3,500. Clinical trial participation is one way to access psilocybin or MDMA therapy at no cost — trial participants receive the treatment free as part of the study protocol. The insurance landscape will change substantially when federal psilocybin approval arrives, likely triggering commercial coverage negotiations similar to those that followed Spravato’s approval.
martha
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