Psilocybin-Assisted Therapy

Unrelieved pain is one the most feared and frequently experienced symptoms in patients with advanced cancer. For this population, pain is typically more severe and occurs in more sites than patients with early-stage disease. It is often viewed as a continuous reminder of disease progression, uncertainty and death, and exists within a complex interplay of physical, emotional, social and spiritual suffering. 

We have been following what has been happening in research focused on the role of psychedelics for end-of-life anxiety, depression, and demoralization with an eye to better supporting the experience our patient community have with pancreatic cancer. 

As a result, we are proud to be investing in groundbreaking research that is examining the potential of psilocybin’s use for managing pain.

While we work to challenge the status quo and invest in projects that will change outcomes, we are also keenly aware that almost 90% of people diagnosed with pancreatic cancer will die – and often in immense pain, suffering and distress.

Testing an improved intervention for managing cancer pain

Previous studies have found two primary non-biological factors associated with unrelieved pain in patients with advanced cancer. First, patients with psychological symptoms such as depression, anxiety or hopelessness, common in this population, experience more pain and lower response to treatment.
Second, negative coping strategies such as pain catastrophizing and poor self-efficacy are consistent predictors of pain. Recent meta-analyses have shown low to moderate effect sizes of specific pain-related behavioral interventions in clinical trials, highlighting the need to develop more effective interventions.

Developing more effective and opioid-sparing therapeutic tools to address opioid-refractory pain would constitute a major advancement in cancer care for all cancers. It is also timely as higher risk of nonmedical opioid use and increase in opioid-associated deaths are observed in patients with cancer in the current context of opioid crisis.

The Pilot Study of Psilocybin-Assisted Therapy for Opioid-Refractory Cancer Pain in Patients with Advanced Cancer is a two-year clinical study taking place at the Dana-Farber Cancer Institute at Massachusetts General Hospital.

Primary Objectives

1. To assess the feasibility and acceptability of psilocybin-assisted therapy in the management of opioid-resistant pain in patients with advanced-cancer.

2. To examine the safety and tolerability of psilocybin-assisted therapy in this population.

Secondary Objectives

1. To assess the preliminary efficacy of the intervention on pain intensity and pain interference. Hypothesis: Pain intensity, as measured by the Brief Pain Inventory (BPI)-short, and Pain interference as measured by the Pain Interference scale, will improve at week-3 post-treatment (primary time point).

2. To assess the effect of psilocybin-assisted therapy on pain medication and other patient-reported outcomes including psychological distress, Mental Adjustment to Cancer, spiritual well-being and health-related quality of life.

Led by Yvan Beaussant, MD, MSc, at the Dana Farber Cancer Institute in collaboration with Harvard Medical School and Massachusetts General Hospital, we expect this study to have significant results, leading to subsequent trial phases over the course of 5+ years that would bring this treatment forward as an approved standard of care option.

Pancreatic Cancer North America

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Pancreatic Cancer North America is a 501 (c)(3) non-profit recognized by the IRS. Tax ID #84-5185853. Any contributions to Pancreatic Cancer North America are tax-deductible as permitted by law.

Pancreatic Cancer North America is proud to work in partnership with Pancreatic Cancer Canada.