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
Single group
Psilocybin
DrugA tryptamine derivative, capsule, taken orally.
Feasibility of Psilocybin-Assisted Therapy
Feasibility of intervention is defined as at least 60% of recruited participants will complete treatment and all assessments.
Acceptability of Psilocybin-Assisted Therapy
Acceptability is defined as \>= 70% of participants will evaluate favorably (agree or strongly agree) acceptability on the Reactions to Research Participation Questionnaire Revised (RRPQ V6b), a 23-item measure scored on a 5-point Likert scale.
Change in Pain Intensity Score from Baseline
Pain intensity score is evaluated by the Brief Pain Inventory (BPI)-short, and change will be calculated between the score at baseline and at assessment at week 3 post dosing. Pain intensity score ranges from 0-10, while a larger number represents worse feelings.
Change in Pain Interference Score from Baseline
Pain interference score is evaluated by the Brief Pain Inventory (BPI)-short, and change will be calculated between the score at baseline and at assessment at week 3 post dosing. Pain interference score ranges from 0-10, while a larger number represents worse feelings.
Change in Pain Catastrophizing Score from Baseline
Pain catastrophizing is measured by the Pain Catastrophizing Scale (PCS), which consists of 13 items describing different thoughts and feelings associated with catastrophizing response-style. Answers are graded on a 5-point scale with endpoints (0) not at all to (4) all the time.
Change in Oral Morphine Equivalent (OME) from Baseline
OME would be obtained from participant's Electronic Medical Record and/or directly from participants based on CDC Oral Morphine Milligram Equivalent Conversion table.
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Yvan Beaussant, MD, MSci
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Cy Biopharma
Collaborator
Pancreatic Cancer North America
Collaborator
