Psychedelic-assisted therapy is rapidly expanding beyond its initial applications in cancer care, with new multi-center studies launching across different patient populations and therapeutic compounds. Manish Agrawal, MD, co-founder and CEO of Sunstone Therapies, reports significant institutional adoption of psychedelic research protocols originally developed for oncology patients.
MDMA Shows Promise in Expanded Access Programs
Sunstone Therapies has accumulated extensive clinical experience with MDMA through expanded access programs, conducting over 150 MDMA sessions as a site for Lykos Therapeutics. "We probably have now conducted close to 150 just MDMA sessions. So, we have a fair amount of experience with it," Agrawal noted.
The clinical observations reveal MDMA's unique therapeutic properties. "It's a very relational drug, and what we see is that it helps people feel less fearful and open up and feel into their heart and have more empathy for themselves as well as for others and facilitates conversation," Agrawal explained. This relational aspect contributes to MDMA's effectiveness in PTSD treatment, as "participants are able to feel safe and are able to then relate to the therapist and talk through some of their experiences."
Group Therapy Model Adapts to Military PTSD Treatment
The group therapy approach pioneered by Sunstone Therapies for cancer patients is being implemented in new settings. A Department of Defense study led by Aaron Wolfgang, MD, will use the same methodology for treating PTSD in active duty military personnel. "It's 4 participants at a time simultaneously with group prep and integration. It's really modeled after our cancer study," Agrawal described, noting the adaptation uses MDMA instead of psilocybin while maintaining the core group structure.
The original model has also influenced variations in therapist supervision, with some institutions implementing remote monitoring approaches where "one therapist in the room and the other one doesn't necessarily have to be in the room, but available by video and watching remotely."
Long-Term Group Integration Shows Sustained Benefits
Participants from Sunstone's initial studies have continued meeting monthly for over three years beyond the formal study period. "The first study's formal study period ended at 8 weeks, but participants wanted to continue to meet, and so they've met monthly now for more than 3 years," Agrawal reported.
The ongoing integration sessions now include participants from multiple cohorts spanning different treatment timeframes. "Now, we have a range of people that have been treated 3 years ago to 3 months ago, and 2 different studies, and it's really amazing to see the connection that they share and how much growth there continues to be," he observed.
A publication highlighting 24-month follow-up results from patients who continued group integration is expected this month, with preliminary indications showing promising outcomes.
Major Cancer Centers Enter Psychedelic Research
The landscape of institutional involvement has transformed significantly. Dana-Farber Cancer Institute has completed a psilocybin study in palliative care, marking entry of major academic medical centers into psychedelic research. "That's quite a different landscape than a few years ago, when we were the only people doing a study with psilocybin in cancer patients," Agrawal noted.
Multiple multi-center studies are launching, including a collaboration between Sunstone Therapies and the Lundquist Institute at UCLA comparing psilocybin versus ketamine in cancer patients with demoralization. Sunstone will serve as the East Coast site for this comparative study, representing "the first study that I'm aware of that will do something like that."
Reunion Neuroscience is preparing to launch a multi-center study using their compound RE104 for adjustment disorder in cancer patients, further expanding the research landscape across multiple sites throughout the United States.
Evolving Professional Perceptions
Oncology professionals' awareness of psychedelic therapy has shifted dramatically. "When we did the first study, it was really the first time that many oncologists or people had heard about psilocybin or were aware of this as a possibility," Agrawal recalled. Current conversations reflect broader awareness: "Now, the conversation is different in that they've generally heard about psilocybin or heard about psychedelic-assisted therapy, whether it's the news or a publication or a friend or family or politics."
Standardization Efforts Continue
Development of standardized protocols for psilocybin and MDMA administration remains ongoing. "We've been in conversation, and we've developed our approaches. It's not been formalized yet, as the drugs aren't approved or are not close to that, but we are thinking more and more about that," Agrawal explained. The protocols must balance therapist, patient, and safety considerations while avoiding excessive burden.
The role of pharmacists in psychedelic therapy continues to evolve, with questions remaining about optimal care team structure. "Is it the pharmacist? Is it the therapist? Is it the investigator? Is it the navigator? So that's a question that we've been actually working to answer," Agrawal noted, suggesting pharmacists may be ideal candidates for ongoing patient education and care team participation.
