Actively Recruiting
Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer
Led by Yvan Beaussant, MD, MSci · Updated on 2025-12-16
15
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
Y
Yvan Beaussant, MD, MSci
Lead Sponsor
C
Cy Biopharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of psilocybin-assisted therapy to help relieve pain that does not respond to opioids in patients with advanced cancer. This phase 2 open-label trial evaluates the feasibility, safety, and early effects of this therapy. Psilocybin affects the serotonin system in the brain, which plays a role in mood, motivation, and impulse control, and it is being investigated as a novel approach within palliative care for pain management. Participants will undergo preparation sessions with therapists either in person or remotely before taking a single oral dose of psilocybin during a supervised treatment session at the research center. After the psilocybin session, participants will have integration therapy sessions the next day and one week later, plus follow-up visits at weeks 2, 3, 5, 8, and 12 to monitor effects and provide support. The study medication is provided by Filament Health, with funding support from Cy Biopharma and Pancreatic Cancer North America. During the study, participants will be assessed through screening tests including blood work and an electrocardiogram. Researchers will evaluate feasibility and acceptability of the therapy, along with changes in pain intensity, pain interference, pain catastrophizing, and opioid use over three weeks. Participants are followed for up to 12 weeks after treatment to monitor outcomes and safety. About 15 people are expected to join this research study.
CONDITIONS
Brief Title
Psilocybin in Cancer Pain Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years old or older
- Participants must have advanced cancer unlikely to be cured or controlled with treatment
- Participants must have progressed on or be intolerant to approved therapies or have refused them
- Average pain must be 4 or higher on the Brief Pain Inventory Severity Scale over the past week
- Participants must be on chronic opioid therapy with an oral morphine equivalent of 200 mg/day or more
- Must have seen a palliative care clinician at Dana-Farber Cancer Institute, MGH, or associated satellites within the last 3 months
- ECOG Performance Status must be 2 or less
- Platelet count must be 50,000/mcL or higher
- AST(SGOT)/ALT(SGPT) levels must be 5 times or less the institutional upper limit of normal
- Must be able to understand and sign informed consent
- Must be able to swallow pills
- Must provide a contact person reachable if participant becomes suicidal or unreachable
- Must agree to inform investigators within 48 hours of new medical conditions or procedures
- Must agree to lifestyle modifications including diet compliance, medication restrictions before sessions, being driven home after sessions, and commitment to dosing and procedures
You will not qualify if you...
- Receiving cytotoxic chemotherapy or radiation within 4 weeks before or planned within 6 weeks that could affect physical function or outcomes
- Impaired oral intake or digestive absorption
- Unable to give informed consent
- Significant suicide risk within past 6 months based on C-SSRS
- History or diagnosis of primary psychotic disorders, bipolar type 1, dissociative identity disorder, or active substance use disorder in past year
- Potential for adverse drug interactions with serotonergic or psychiatric medications that cannot be tapered
- Significant uncontrolled medical conditions increasing risk of psilocybin, including seizure disorder, heart disease, or neurological disorders
- Untreated brain tumors or metastases
- Severe lab abnormalities that could affect psilocybin metabolism or cause confusion
- Diagnosis of cirrhosis or liver failure
- Uncontrolled hypertension or heart rate over 100 bpm on multiple occasions
- History of certain arrhythmias or heart conditions
- Marked baseline prolongation of QT/QTc interval
- Pregnant, nursing, or able to become pregnant without effective birth control
- Hypersensitivity to any ingredient of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Approximately 2 weeks
Participants complete preparation sessions, receive a single psilocybin dose during an in-clinic treatment session, and attend integration sessions with therapists.
2 preparation sessions (in-clinic or remote), 1 in-clinic treatment session, and 2 integration sessions (1 in-clinic the day after treatment, 1 in-clinic or remote 1 week later)
Duration - Up to 12 weeks after treatment
Participants attend follow-up visits with therapists to monitor progress and outcomes after psilocybin administration.
5 visits (in-clinic or remote) at weeks 2, 3, 5, 8, and 12 post-treatment
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
A
Amani Ingram
I
Isabel Kristan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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