The prevalence of distress among women with late-stage gynecologic cancers calls for well-designed studies to assess the safety and efficacy of psychedelics for this patient population, according to authors of a published commentary.
Psychedelics — specifically psilocybin — have shown promise for treating various psychological symptoms, including anxiety, depression, PTSD and end-of-life distress, the authors wrote in International Journal of Gynecological Cancer.
“There is a clear unmet clinical need for therapeutics to ease the psychological challenges often faced by women with late-stage gynecologic cancers,” commentary co-author Moran Amit, MD, PhD, assistant professor in the department of head and neck surgery at The University of Texas MD Anderson Cancer Center, told Healio. “Recent data have shown the efficacy of psilocybin [for] improving patient-reported outcomes for cancer-associated anxiety and depression, which led us to open enrollment for a trial that will examine the effects of psilocybin for patients with controlled advanced cancer on maintenance therapy experiencing challenges with mental health.”
Amit spoke with Healio about why the time has come to examine the use of psilocybin and other psychedelics in this patient population, as well as the advantages they may offer compared with other therapeutic approaches.
Healio: What prompted interest in this area?
Amit: We are improving our oncological survival outcome for patients with cancer, and we see a growing population of patients who are living longer. However, both the cancer diagnosis and treatment that we deliver adversely affect their quality of life, performance, and ability to go back to their communities and work and function properly. This is due to various reasons, including neurologic deficits and emotional aspects associated with cancer diagnosis and treatment. We haven’t had a good solution for any of it beyond palliative care or psychiatric medication.
In recent years, we have seen more reports in high-impact peer-reviewed journals that report good data on the utilization of psilocybin and other hallucinogenic drugs. The data are very compelling. Psilocybin has been rigorously investigated and reviewed, and this therapy is successful at alleviating depression, anxiety, PTSD and, to some extent, addiction among certain patients. This is comparable to the current standard-of-care psychiatric medications, but we see that in many instances, the effect is more durable with psilocybin. After a few sessions, patients appear to improve and remain well emotionally.
On one hand, there is a need. On the other, there are new opportunities to repurpose this drug for patients with cancer. That is what prompted us to initiate this study.
Fortunately, we received support from MD Anderson, and we’ve created a large team together with Lorenzo Cohen, PhD, professor in the department of palliative, rehabilitation and integrative medicine and director of the integrative medicine program at MD Anderson, who has been invested in integrative medicine for many years. We also are very grateful to Gateway for Cancer Research for its invaluable support in funding the trial. The next logical step for us was to define who we wanted to treat — patients who have active malignancy and are receiving treatment for active cancer.
Healio: Why do you and colleagues believe the time has come to explore this further?
Amit: There is a growing amount of efficacy data that show a durable effect in different patient populations with similar needs. Many of these patients are resistant to traditional therapeutics, and traditional psychotherapeutic approaches often require more time than is ideal for these patients. There’s a lot of enthusiasm in the field of psilocybin research and psilocybin-assisted psychotherapy among patients who are terminally ill. These patients require a lot of focus research-wise, but we’ve seen within the last 2 decades a growing population of patients who are not necessarily cured of their cancer, but who live with it for many years because of the emergence of targeted therapy and immunotherapy. This brings new problems in the form of anxiety, stress and existential crisis because cancer is intimidating and scary for many people.
When we contemplated this research, we started conducting focus groups and talked with patients to see what their needs were. We found patients were interested in pursuing anything that may help alleviate these symptoms and had great openness to new types of therapy, and psilocybin-guided psychotherapy was one of them.
Healio: Are there any concerns with safety?
Amit: When looking at the safety profile of these medications, many studies are actively accruing patients for psilocybin-guided psychotherapy. Several of these studies include patients with cancer. The adverse effects that we have seen in those studies are mostly in the realm of temporary shifts in blood pressure and heart rate. Compared with drugs in the psychiatric world, psilocybin-guided therapy is considered very safe. However, with psilocybin and any hallucinogenic drug, safety depends on the setting. When we say that we’re going to treat people with psilocybin-guided psychotherapy, it is not just taking the pills. We also bring patients in for a few weeks of preparation and psychotherapy sessions. We conduct sessions in which we have two therapists in the room and the clinician is monitoring the patient, who is well aware of what is going on.
Then we conduct an integration session the day after or the week after, and 2 or 3 weeks after we repeat the psilocybin-guided psychotherapy. We then perform consolidation assessments and the patient is monitored for 2 to 6 months.
When we talk about the adverse effects of these drugs, many people have misconceptions. Of course, looking at an uncontrolled substance and its unregulated use is one thing, but we are talking about controlled and highly monitored use in which we invest most of our time preparing the patient for the session and monitoring the patient closely during and after treatment. When a patient comes to us ready and prepared for the experience, the adverse effects of high blood pressure and high heart rate are slim to nonexistent.
Healio: How might psilocybin be superior to current approaches?
Amit: Psilocybin may offer improved duration of the effect, ease of use and a proven safety profile. In the context of cancer, our hope is that it will lead to central nervous system plasticity not seen with current approaches, and that this could improve patient outcomes.
Healio: Is there anything else that you would like to mention?
Amit: Beyond the psychological or emotional effects of psilocybin, we continue to see reports that it also positively affects the nervous system. We will continue to investigate this. Part of our research aims to look at the brains of patients who are in functional MRI. There is a lot of potential in this class of drugs, but everything depends on the steps taken. Patients need to be in the right mindset, and this needs to happen in a controlled and safe setting, which is exactly what we aim to establish.
- Explore psilocybin and other psychedelics for women’s cancer distress, urge doctors (press release). Available at: www.bmj.com/company/newsroom/explore-psilocybin-and-other-psychedelics-for-womens-cancer-distress-urge-doctors/. Published July 18, 2023. Accessed August 14, 2023.
- Yaniv D, et al. Int J Gynecol Cancer. 2023;doi:10.1136/ijgc-2023-004659.