Psilocybin, Ketamine, and MDMA in Cancer Care: Next Steps in Psychedelic Research

As interest grows in the therapeutic potential of psychedelics, the role of pharmacists in ensuring safe, effective, and ethically sound care is becoming increasingly important. In this interview with Pharmacy Times®, Manish Agrawal, MD, co-founder and CEO of Sunstone Therapies and a leader in psychedelic research in oncology, discusses ongoing efforts to develop standardized protocols for psilocybin and MDMA administration.

Agrawal reflects on the evolving care team dynamics in psychedelic therapy and the unanswered questions around provider roles in this novel space. He shares insights from his team’s extensive experience with MDMA through expanded access, including more than 100 treatment sessions, and comments on the drug’s unique relational properties. Agrawal also previews an upcoming study comparing psilocybin and ketamine in patients with cancer and offers perspective on MDMA’s potential applications in settings beyond palliative care—including conflict resolution.

Pharmacy Times: Since you last spoke to Pharmacy Times in April 2023 about pharmacists' role in handling psilocybin and Risk Evaluation and Mitigation Strategy (REMS) programs, have you worked with pharmacy teams to develop standardized protocols?

Manish Agrawal, MD: 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, and that's going to be a really important process for us to think through, because it is both the therapist, the patient, and how do you qualify him without it being burdensome but also providing safety. So, we're actually deep in conversations with our partners here on that.

Pharmacy Times: Are pharmacists at your site involved in therapy planning or integration beyond dispensing—such as in patient education or safety monitoring?

Agrawal: Not formally, but certainly with patient education, it's becoming more of a role. It's a good question, because [who] does this fall onto? 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. We recognize that is education is needed, and ongoing involvement is needed, and [who] that falls into is an open question, and I think it's a good point that the pharmacist might be the ideal person to be part of the care team that could do that.

Pharmacy Times: Would you be able to speak to the potential of ketamine and/or MDMA for the palliative setting for patients with cancer, and are you aware of research investigating these drugs for this setting?

Mushrooms containing psilocybin growing in the forest. Image Credit: © Sergei - stock.adobe.com

Agrawal: So, we have one study using MDMA for cancer patients and a family member or significant other. I'm not aware of any MDMA studies that are ongoing looking at this in palliative care. There was one small study published that had mixed results. Then with ketamine, again, there's been reports of it being potentially beneficial, but I've not seen any formal study.

The study that we're going to be embarking on will compare ketamine to psilocybin, and that's the first study that I'm aware of that will do something like that.

Pharmacy Times: Beyond palliative care, what are your thoughts on the potential for the use of MDMA for conflict resolution?

Agrawal: Yeah, happy to answer that. We actually have extensive experience with MDMA. We were an expanded access site for Lykos Therapeutics and conducted over 100 MDMA sessions. So, we probably have now conducted close to 150 just MDMA sessions. So, we have a fair amount of experience with it. I think it's really it's not surprising to me. It's promising because 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 [it] facilitates conversation.

I think it's one of the ways that it's so effective in PTSD, is that participants are able to feel safe and [are] able to then relate to the therapist and talk through some of their experiences. In that way, it's such a relational medication that I'm not surprised that it could be effective in a setting like that, if it's appropriately used.