Beyond Ketamine: How Clinics and Retreats Are Preparing for MDMA and Psilocybin
Last reviewed and updated: July 5, 2026
Key Takeaways
| MDMA timeline pushed | The FDA rejected MDMA-assisted therapy in August 2024 — clinics preparing for MDMA adoption are now planning for resubmission and a 2027-2028 approval window at the earliest. |
| Psilocybin next | Compass Pathways submitted a rolling NDA for psilocybin in 2025, with an FDA decision expected in 2027-2028 — giving ketamine clinics roughly 2 years to prepare. |
| LSD surprise | Definium Therapeutics (formerly MindMed) completed Phase 3 for its LSD compound DT120 in June 2026, unexpectedly advancing LSD ahead of MDMA on the regulatory timeline. |
| Clinic evolution | Forward-looking ketamine clinics are investing in therapist training, adding integration sessions, and learning somatic modalities — capabilities that will transfer directly to psilocybin and MDMA protocols. |
| Retreat differentiation | Retreat centers are positioning themselves as integration-therapy specialists, anticipating that day-clinics handling drug administration will seek integration partners with deeper therapeutic capability. |
Ketamine-assisted psychotherapy is already here, with clinics in every major city. Savvy medical professionals are warming up to adding MDMA and psilocybin-assisted therapy. Both medicines are just over the horizon. Both give patients a new view of the world, and themselves.
What’s coming down the pike? Plenty.
For starters, in 2020, Oregon became the first state in the U.S. to legalize the supported use of psilocybin through a ballot initiative. As a result, the nation’s first psilocybin-therapy treatment centers are now opening their doors. Colorado passed the Natural Medicine Health Act, which opens a path to availability of psilocybin, dimethyltryptamine, ibogaine, and mescaline. Other states and cities are looking to follow suite with similar programs.
What’s more, with the successful conclusion of MAPS’ phase 3 trials, FDA approval for MDMA-assisted therapy is likely in the near future, with psilocybin-assisted therapy not far behind.
There are, of course, considerable differences between psilocybin and MDMA on the one hand, and ketamine on the other. Trip length is one key difference. Ketamine lasts about two hours. MDMA and psilocybin last four to six hours.
What might MDMA and ketamine-assisted therapy treatments look like? Will psychedelics be administered in clinic sessions, as with most ketamine journeys? Or in nature, as a retreat? Will they be available at the same practice, with the same clinician you already know and trust?
To help us understand how U.S.-based psychedelic practitioners can adapt to new medicines, and what can patients expect, we talked to experts from around the world about their experiences offering psychedelics beyond ketamine. And we asked U.S.-based practitioners who already use ketamine about their plans to expand into MDMA and psilocybin.
Dr. Mike Cooper – Innerwell At-Home Ketamine Therapy
MDMA has a unique mechanism of action in the brain, and its subjective effects are different from other psychedelic compounds. That being said, even though the quality of psychedelic experiences can differ with each compound, the structure of therapy and the skills needed to provide it are essentially the same.
Innerwell’s model of ketamine-assisted psychotherapy (KAP), which is based on the psychedelic-assisted psychotherapy model, translates seamlessly into MDMA-assisted psychotherapy. Innerwell therapists who are already trained in KAP have a solid foundation that can be supplemented with a continuing education course on MDMA.
MDMA-assisted psychotherapy will only be offered in-person, which is different from KAP, which can also be delivered via telehealth. Our digital platform supports in-person visits in addition to telehealth, and will enable data-driven, personalized care for MDMA-assisted psychotherapy similarly to KAP. We’re also in the process of contracting with insurance payers, ensuring delivery of in-network MDMA-assisted psychotherapy once it’s approved by the FDA. We also have the clinical staffing and licensing required to operate a full-time treatment center.
— Dr. Mike Cooper, Medical Director of Innerwell At-Home Ketamine Therapy
RELATED: At-Home Ketamine Treatment Vs In-Clinic Ketamine Experiences: Pros and Cons
Dr. Beth Ballen – Ballen Medical and Wellness
Our Denver ketamine center has provided ketamine therapy for over 11 years now, so in a way we’ve already been preparing for this exciting new wave of psychedelic medicine. Even though it’s technically a dissociative, ketamine infusions can be very similar to psychedelic experiences. So we already focus on things like set and setting, and helping patients integrate their experiences with ketamine-assisted psychotherapy. Over the years we’ve made our private treatment rooms feel more like cozy living rooms than clinical spaces. Thanks to our partner Wavepaths, we can offer patients music that’s been specially designed to enhance psychedelic experiences. Psilocybin and other plant medicine has been decriminalized in Colorado, but it’s not legal for us to prescribe just yet, so we’re also taking this time to learn from the wonderful psychedelic community. We had a booth at the MAPS Psychedelic Science conference here in Denver this summer, we just attended Psycon, and we’ve been talking to providers in Oregon who are kind enough to share what’s working best for their psilocybin patients. All we really need at this point are the licenses to become available, which will happen in 2024 for us here in Denver. We couldn’t be more excited for that.
RELATED: Are Mushrooms Legal in Colorado? The Answer is a Little Tricky
— Beth Ballen, MD, Integrative Psychiatrist and Founder of Ballen Medical and Wellness
Dr. Owen Scott Muir – Fermata
Here at Fermata, we are interested in the safe and legal treatments that work rapidly and better than existing treatments. What we’ve been doing to prepare is reviewing the literature. We’re trying to understand based on the published data what is going to be the most effective for whom. We already specialize in accelerated transcranial magnetic stimulation, the Nightwear device for PTSD, the Monarch eTNS device for ADHD. Deploying all of these FDA-cleared devices entail creating workflows that are going to be similar to what will be necessary for prescribing psychedelic medicines. If you want to be ready to prescribe complex treatments, start prescribing complex treatments now, which are already legal, safe and effective. The clinical preparations involved and systems needed will be the training wheels you’ll need to provide safe, effective, but more complicated treatments later. This involves workflows and protocols that ensure reliability in implementation and risk management. You don’t need to wait for MDMA to build systems that could support a practice that prescribes MDMA. You can start now. Dr. Muir writes a newsletter, The Frontier Psychiatrists, daily, about our newest learnings and clinical innovations.
— Dr. Owen Scott Muir, Co-Founder of Fermata Health
Andrew Tansil – Sayulita Wellness Mushroom Retreat
At Sayulita Wellness Retreat, we’re keenly attuned to the evolving landscape of psychedelic therapy, particularly regarding psilocybin and MDMA. As legal frameworks shift, we’re preparing to adapt responsibly and innovatively. Our commitment is to integrate these substances into our retreat programs in a way that’s both legally compliant and therapeutically profound. Already, with psilocybin, we’ve learned that each individual’s journey is unique, requiring personalized care and a deeply empathic approach. Our trained therapists and guides are skilled in facilitating experiences that honor the powerful potential of these substances while prioritizing safety and emotional support. We’ve seen transformative outcomes, reinforcing our belief in the therapeutic potential of psychedelics. As we anticipate legal changes, we are developing comprehensive protocols and training programs to ensure we remain at the forefront of psychedelic therapy, offering experiences that are not just transformative but also rooted in legal, ethical, and professional standards.
— Andrew Tansil, Sayulita Wellness
Brad Kallenbach – EQNMT
Having conducted several psilocybin-assisted therapy retreats in legal geographies with over a hundred participants, EQNMT’s key learning has been that positive, lasting change is only possible within a carefully considered therapeutic framework. Irrespective of the choice of medicine, this framework necessarily entails thorough screening and preparation, very careful attention to set and setting, and rigorous integration. Most importantly, our work with psilocybin has confirmed a truism of all psychological healing: we are hurt in relationship and we are healed in relationship.
— Brad Kallenbach, Head Clinical Psychologist & Co-Founder of EQNMT
Dr. Mona Itani – Cambridge Biotherapies
As pioneers in advanced mental health treatments, the team at Cambridge Biotherapies in Massachusetts is keenly observing regulatory changes around MDMA and Psilocybin-assisted therapies.
We believe that diversifying our treatment modalities is essential for comprehensive patient care, expanding the framework for certain mental illnesses. Upon FDA approval, we plan to integrate MDMA-assisted therapy as a specialized service for patients who have challenges managing PTSD symptoms. It’s not just about adding new treatments, but also ensuring they align with our rigorous medical protocols and standards of patient care.
One crucial lesson we’ve learned from our ketamine treatment cohort outcomes is the significant impact of the ‘set and setting’ when combined with the best therapeutic approach. We’re leveraging this knowledge to design therapeutic environments that can enhance the effectiveness of MDMA or Psilocybin. It’s an exciting, responsible journey towards broadening mental health solutions.
—Mona Itani, M.D. at Cambridge Biotherapies
Ajay Kumra – Resilience Integrative Wellness
At our clinic, we are ardently dedicated to advancing the intersection of contemporary psychopharmacology and time-honored traditional medical practices. The impending FDA ratification of MDMA and psilocybin-assisted therapies represents a shift in the therapeutic landscape. Our commitment to these modalities is unwavering, and we will meticulously integrate them by ensuring that our practitioners undergo rigorous academic and clinical training. We believe in the synergetic potential of modern scientific methodologies with ancient therapeutic wisdom. As regulatory frameworks evolve, our strategy remains agile, always prioritizing evidence-based, ethically sound, and patient-centric approaches.
— Ajay Kumra, Manager at Resilience Integrative Wellness
Luc van Poelje – Psychedelic Insights
Working with sacred or therapeutic psychedelic medicines requires safety. This safety requires experience from the practitioner, laws and safety from the government, and last but not least the client or patient themselves. This can manifest in certifications, credibility, trust and professionalism and screenings and above all experience to optimise positive outcomes. Healing or personal development insofar as these are different, requires courage, acceptance, understanding and ultimately self love in deep psychological and transformational processes. Different from prescription drugs, these require personal experience by the providers. Trust your gut and your intuition after researching and exploring what feels good to you personally. Understand that you are unique and any first psychedelic experience is the beginning of a healing journey.
— Luc van Poelje Founder, CEO of Psychedelic Insights
Conclusion
For now, ketamine therapy is the only psychedelic treatment broadly available across the country, but that is quickly changing. While we can look to the programs in Oregon and Colorado as guides, clinics need not wait for legalization to begin planning and patients need not wait to find other forms of psychedelic therapy available in their area.
2026 Update
The preparation conversation at ketamine clinics changed significantly after August 2024. MDMA’s FDA rejection — due to trial methodology concerns rather than efficacy — pushed the “when do we prepare for MDMA?” question into a longer planning horizon. But psilocybin moved to the front: Compass Pathways’ rolling NDA submission in 2025 puts a potential FDA decision in 2027-2028, giving forward-thinking clinics roughly two years to prepare their staff, protocols, and clinical frameworks. June 2026 added an unexpected variable: Definium Therapeutics’ completion of the first successful LSD Phase 3 trial may put LSD ahead of MDMA on the approval timeline — a scenario most clinics hadn’t planned for.
The clinics and retreats best positioned for the transition are those that have invested in the therapeutic infrastructure, not just the drug administration protocol. Psilocybin-assisted therapy requires trained therapists, robust preparation and integration sessions, somatic capability, and experience holding longer and more intense experiences than ketamine infusions. Oregon and Colorado’s licensed programs are functioning as de facto training grounds — ketamine providers who have sent staff to observe or participate in OR/CO sessions report being significantly better prepared for the psilocybin transition. April 2026’s Executive Order added institutional urgency: VA providers are now being encouraged to develop the capacity for multiple psychedelic modalities, further accelerating the training demand.
Frequently Asked Questions
- Are ketamine clinics prepared to offer psilocybin therapy?
- Preparation varies significantly by clinic. Clinics that have invested in therapist training, integration sessions, and somatic modalities are reasonably well-positioned. Clinics that operate primarily as infusion rooms (drug administration without deep therapeutic support) will need significant infrastructure development. Psilocybin sessions last 4-6 hours (vs. 45-90 minutes for ketamine infusions) and require more intensive preparation and integration — a different clinical model.
- When might psilocybin therapy be available at clinics in the U.S.?
- Compass Pathways submitted a rolling NDA in 2025, with an FDA decision expected in 2027-2028. If approved, clinical rollout would take additional time for training, licensing, and protocol development. Optimistic projections suggest 2028-2029 for psilocybin therapy in mainstream ketamine-style clinical settings. Oregon and Colorado’s licensed programs are already operational for those willing to access state-licensed services now.
- What happened to the timeline for MDMA therapy at clinics?
- The FDA rejected MDMA-assisted therapy in August 2024. Lykos Therapeutics is redesigning the trial to address the FDA’s methodology objections (functional unblinding, therapist conduct, abuse potential). A resubmission is expected, but the timeline is uncertain — estimates range from 2026 to 2028+ for resubmission, with FDA review adding another year or more. MDMA is now behind psilocybin (and potentially LSD) on the approval timeline.
- What training should ketamine providers get now to prepare for psilocybin?
- Training programs recommended by experts preparing for the psilocybin transition include: MAPS-trained facilitator certification (background in trauma-informed MDMA protocols that transfer well to psilocybin), Fluence (psychedelic therapy for licensed clinicians), CIIS Certificate in Psychedelic-Assisted Therapies, and direct observation at Oregon or Colorado service centers. Somatic modality training (IFS, somatic experiencing, EMDR) is increasingly considered essential preparation.
RELATED READING: Ketamine Therapy | Psilocybin Therapy | Psychedelic Therapy
