Substance Related Disorders

Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Opioid-Related Disorders

Cancer Pain

Pain

Pain, Intractable

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Psychotropic Drugs

All Drugs and Chemicals

Analgesics

Central Nervous System Depressants

Psilocybin

Analgesics, Opioid

Hallucinogens

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.

A tryptamine derivative, capsule, taken orally.

Amani Ingram

Isabel Kristan

Yvan Beaussant, MD

Mihir Kamdar, MD

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)

This study is a phase 2 open label, single center, concurrent mixed-methods trial to assess the feasibility of a novel palliative-care informed psilocybin-assisted psychotherapy regimen to alleviate opioid-refractory pain in patients with advanced-cancer. Psilocybin works on the serotonin system in the brain which is linked to the regulation of mood, motivation and impulse control.

Psilocybin is an "Investigational" drug, meaning that the study drug has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. However, investigators have permission from the FDA to use this drug in this research study.

The research study procedures include screening for eligibility, an electrocardiogram, blood tests, and the study intervention includes preparation, evaluations, one psilocybin session and follow up visits.

Participants will be followed for up to 12 weeks (approximately 3 months) after receiving the study treatment.

It is expected that about 15 people will take part in this research study.

Filament Health is supporting this research study by providing the study investigational medication, psilocybin.

Cy Biopharma and Pancreatic Cancer North America are supporting this research study by providing funding.

Psilocybin in Cancer Pain Study

Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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

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.

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.

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.

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.

OME would be obtained from participant's Electronic Medical Record and/or directly from participants based on CDC Oral Morphine Milligram Equivalent Conversion table.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Psilocybin in Cancer Pain Study	NCT06001749	Opioid-Related ... Pain Management Pain Management... Advanced Cancer Advanced Cancer...	Psilocybin	18 Years -	Dana-Farber Cancer Institute
Psilocybin in Cancer Pain Study	NCT06001749	Opioid-Related ... Pain Management Pain Management... Advanced Cancer Advanced Cancer...	Psilocybin	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for pain management and care