The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer.
The name of the study intervention used in this research study is:
Psilocybin (a tryptamine derivative)
Participants must be 18 year old or older;
Participants must have advanced cancer, defined as a cancer that is unlikely to be cured or controlled with treatment;
Participants must have progressed on or be intolerant to approved therapies with a known clinical benefit (unless it is documented that they have refused such treatments);
Participants must evaluate their average pain on BPI Severity Scale ≥ 4/10 over the past week;
Participants who receive concurrent (less than four weeks or planned within 6 weeks) cytotoxic chemotherapy or radiation therapy that may impair general level of physical functioning or affect study outcomes;
Participants with a condition impairing oral intake or digestive absorption;
Participants who are not able to give adequate informed consent;
Participants who have a significant suicide risk as defined by suicidal ideation with intent and with or without a plan as endorsed on items 4 and/or 5 on the C-SSRS within the past 6 months or at V0
Yvan Beaussant, MD, MSci
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Cy Biopharma
Collaborator
Pancreatic Cancer North America
Collaborator