15 Participants Needed

Psilocybin for Cancer Pain

Recruiting at 2 trial locations
AI
IK
Overseen ByIsabel Kristan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications that could interact with psilocybin, such as antidepressants, antipsychotics, and mood stabilizers. These medications will need to be tapered off appropriately to avoid withdrawal effects before participating in the study.

Is psilocybin safe for human use?

Psilocybin is generally considered safe when used in controlled settings with proper screening and support, although it can cause challenging psychological experiences and, in rare cases, lead to risky behavior or enduring psychological distress. It is important to use it under medical supervision, especially for individuals with pre-existing mental health conditions.12345

How does the drug psilocybin differ from other treatments for cancer pain?

Psilocybin is unique because it is a psychoactive compound found in certain mushrooms, known for its hallucinogenic effects, and is being explored for its potential to alleviate cancer pain by affecting the brain's perception of pain. Unlike traditional pain medications, psilocybin may offer a novel approach by potentially altering consciousness and emotional responses to pain.36789

What data supports the effectiveness of the drug psilocybin for cancer pain?

Research suggests that psilocybin may have therapeutic benefits in palliative care, which often includes managing cancer pain, although it is not yet approved for this use in the U.S. Additionally, psilocybin has shown potential in treating major depressive disorder, which can be relevant as depression often accompanies chronic pain conditions.37101112

Who Is on the Research Team?

YB

Yvan Beaussant, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults with advanced cancer experiencing pain not relieved by opioids, on a high opioid dose, and seen by palliative care recently. They must be able to take pills, consent to the study, have certain organ functions within safe ranges, and commit to lifestyle changes for the trial. Pregnant women or those who can become pregnant without effective birth control are excluded.

Inclusion Criteria

I can take care of myself and am up and about more than 50% of my waking hours.
My cancer is advanced and not likely to be cured.
My average pain level over the past week has been 4 or higher on a scale of 10.
See 9 more

Exclusion Criteria

I am not on any medications that can't be stopped and would interfere with the study drugs.
I have risk factors for a specific heart rhythm condition (like heart failure or low potassium).
Participants with 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
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preparation

Participants undergo 2 preparation sessions with therapists, either in-clinic or remote

1-2 weeks
2 visits (in-person or remote)

Treatment

Participants receive a single psilocybin session in-clinic with therapists

1 day
1 visit (in-person)

Integration

Participants have integration sessions with therapists, including one the day after treatment and another one week later

1 week
2 visits (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at weeks 2, 3, 5, 8, and 12

12 weeks
5 visits (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin
Trial Overview The trial is testing psilocybin-assisted therapy's safety and ability to reduce pain in patients with advanced cancer whose pain isn't managed by opioids. Participants will receive doses of psilocybin under controlled conditions.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention

Psilocybin is already approved in United States, European Union for the following indications:

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Approved in United States as Psilocybin for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Psilocybin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yvan Beaussant, MD, MSci

Lead Sponsor

Trials
2
Recruited
30+

Cy Biopharma

Collaborator

Trials
1
Recruited
20+

Pancreatic Cancer North America

Collaborator

Trials
1
Recruited
20+

Published Research Related to This Trial

Psilocybin shows promising effects in alleviating anxiety, depression, and emotional distress in palliative care patients, with a favorable safety profile, based on recent studies and reports.
Despite its potential benefits, psilocybin is not yet approved for therapeutic use in the U.S., and significant barriers exist for access, particularly for vulnerable populations like the elderly and those in palliative care.
Psilocybin in Palliative Care: An Update.Whinkin, E., Opalka, M., Watters, C., et al.[2023]
Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.
Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.
The pharmacology of psilocybin.Passie, T., Seifert, J., Schneider, U., et al.[2016]
This study found that the binding of serotonin 2A receptors (5-HT2AR) in the brain can predict how long the peak effects of psilocybin last and how quickly individuals return to normal consciousness after its effects wear off.
Higher levels of 5-HT2AR binding were associated with lower scores on the Mystical Experience Questionnaire, suggesting that individual differences in receptor availability may influence the subjective experience of psilocybin, which could have implications for its therapeutic use.
Brain serotonin 2A receptor binding predicts subjective temporal and mystical effects of psilocybin in healthy humans.Stenbรฆk, DS., Madsen, MK., Ozenne, B., et al.[2022]

Citations

Psilocybin in Palliative Care: An Update. [2023]
The pharmacology of psilocybin. [2016]
Brain serotonin 2A receptor binding predicts subjective temporal and mystical effects of psilocybin in healthy humans. [2022]
Therapeutic Effects of Medicinal Mushrooms on Gastric, Breast, and Colorectal Cancer: A Scoping Review. [2023]
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]
Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. [2021]
Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]
[Hallucinogenic mushrooms]. [2018]
Intravenous mushroom poisoning. [2019]
Magic truffles or Philosopher's stones: a legal way to sell psilocybin? [2019]
11.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Apoptosis and Anti-cancer Drug Discovery: The Power of Medicinal Fungi and Plants. [2021]
Genetic Survey of Psilocybe Natural Products. [2022]
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