Psilocybin in Cancer Pain Study

NCT06001749 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-325
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Opioid-Related Disorders; Pain Management; Pain Management and Care; Advanced Cancer; Advanced Cancers

Keywords

Opioid-Related Disorders; Pain Management; Pain Management and Care; Advanced Cancer; Advanced Cancers

Outcome Measures

Primary Outcomes (2)

• Feasibility of Psilocybin-Assisted Therapy

  Feasibility of intervention is defined as at least 60% of recruited participants will complete treatment and all assessments.

  3 weeks

• 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.

  3 weeks

Secondary Outcomes (4)

• Change in Pain Intensity Score from Baseline

  3 weeks

• Change in Pain Interference Score from Baseline

  3 weeks

• Change in Pain Catastrophizing Score from Baseline

  3 weeks

• Change in Oral Morphine Equivalent (OME) from Baseline

  3 weeks

Study Arms (1)

Psilocybin

EXPERIMENTAL

Participants will complete study procedures as follows: * 2, in-clinic or remote, preparation sessions with therapists. * In-clinic treatment session with therapists at Dana-Farber Cancer Institute. Participants will take a predetermined amount of psilocybin once. Participants will be transported home by a friend or family member. * In-clinic integration session the day after psilocybin administration with therapists. * In-clinic or remote, integration session with therapists 1 week after psilocybin administration. * In-clinic or remote follow visits with therapists at week 2, 3, 5, 8, and 12 after psilocybin administration.

Drug: Psilocybin

Interventions

Psilocybin DRUG

A tryptamine derivative, capsule, taken orally.

Psilocybin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 must receive chronic opioid pharmacotherapy for pain with an Oral Morphine Equivalent (OME) ≥ 200mg/day;
• Participants must have been seen by a palliative care clinician either at DFCI, MGH or associated satellites in the last three months;
• Participants must have an ECOG Performance Status ≤ 2
• Participants must meet the following organ and marrow function on their last available bloodwork as defined below:
• Platelets ≥ 50,000/mcL
• AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN
• Participants must be able to understand and willing to sign a written informed consent document
• Participants must be able to swallow pills.
• Participants must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
• Participants must agree to inform the investigators within 48 hours of any new medical conditions and procedures.
• Participants must agree to the following lifestyle modifications (described in more detail in Section 3.4 Lifestyle Modifications):

You may not qualify if:

• 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
• Participants who have a history of, or a current diagnostic of primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder; and participants who have an ongoing substance use disorder (defined as active in the past year). Participants with first-degree relatives with schizophrenia or bipolar disorder may be eligible depending on their age and personal and family psychiatric history. The decision will be made by the principal investigator and study psychiatrist based on risk assessment.
• Serotoninergic antidepressants
• Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs)
• Tricyclic Antidepressants (TCAs)
• Efavirenz
• serotonin-acting dietary supplements (i.e. 5-hydroxy-tryptophan or St. John's wort)
• Centrally-acting serotonergic agents (e.g. MAO inhibitors)
• Antipsychotics (e.g. first and second generation)
• Mood stabilizers (e.g. lithium, valproic acid)
• Aldehyde dehydrogenase inhibitors (e.g. disulfiram)
• Significant inhibitors of UGT 1A0 or UGT 1A10 Any psychiatric medication will be tapered if possible in an appropriate fashion to avoid withdrawal effects. They will be discontinued long enough before the psilocybin Session to avoid the possibility of any drug-drug interaction (the interval will be at least five times the particular drug and active metabolites' half-life + one week for stabilization). See section 5.3 of the protocol for concomitant medications and tapering instructions.

Sponsors & Collaborators

• Yvan Beaussant, MD, MSci: lead
• Cy Biopharma: collaborator
• Pancreatic Cancer North America: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Agnosia

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Yvan Beaussant, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amani Ingram

CONTACT

8572151476; patresearch@dfci.harvard.edu

Isabel Kristan

CONTACT

6176322574; patresearch@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: September 23, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)