Study on Psilocybin for Relieving Chronic Neuropathic Pain in Patients with Chemotherapy-Induced Peripheral Neuropathy

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What is this study about?

This clinical trial is focused on exploring new ways to help people who experience chronic pain after undergoing chemotherapy. The specific condition being studied is called chemotherapy-induced peripheral neuropathy, which is a type of nerve pain that can occur after cancer treatment. The study is testing a new treatment using a substance called psilocybin, which is derived from a type of mushroom. Psilocybin is being investigated for its potential to reduce pain and improve daily functioning for those affected by this condition.

Participants in the study will receive either psilocybin capsules or a placebo. The psilocybin capsules come in two different doses: 1 mg and 25 mg. The study aims to see if psilocybin can help reduce the interference of pain with daily activities. The trial will also look at how participants feel about the treatment and any changes in their emotional and psychological well-being. The study will be conducted over a short period, with participants taking the medication orally.

The main goal of the study is to assess how feasible it is to use psilocybin as a treatment for chronic neuropathic pain caused by chemotherapy. Researchers will also gather information on how well participants tolerate the treatment and any side effects they might experience. This trial is an important step in understanding whether psilocybin could be a helpful option for managing pain in people who have undergone chemotherapy.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes verifying that the patient is at least 18 years old, has chronic neuropathic pain following chemotherapy, and meets other criteria such as stable pain treatment and the ability to understand Dutch.

2 baseline measurements

Baseline measurements are taken to assess pain levels and other health indicators. This includes using scales to measure pain intensity, emotional state, and quality of life.

3 medication administration

The patient receives the study medication. This includes Oxazepam in tablet form and Psilocybin in capsule form. The psilocybin is administered in two dosages: 1 mg and 25 mg. All medications are taken orally.

4 monitoring and follow-up

The patient is monitored for any adverse effects and changes in pain levels. Follow-up assessments are conducted to evaluate the impact of the medication on pain interference, emotional state, and overall quality of life.

5 final evaluation

At the end of the trial, a final evaluation is conducted. This includes a comprehensive assessment of the patient’s pain levels, emotional well-being, and any changes in quality of life since the start of the trial.

Who Can Join the Study?

Must be an adult (at least 18 years old).
Must have chronic neuropathic pain that started after chemotherapy. This means ongoing nerve pain caused by chemotherapy treatment.
Must be at least six months past the diagnosis of chemotherapy-induced peripheral neuropathy. This is a condition where nerves are damaged due to chemotherapy, leading to pain, tingling, or numbness, and it must be confirmed by a doctor.
Must report an average pain level of at least 4 on a scale from 0 to 10 in the week before being assessed for the study. On this scale, 0 means no pain, and 10 means the worst pain imaginable.
Must have a stable pain treatment plan, meaning no changes in pain medication for at least two weeks before joining the study.
Must be able to read, write, and understand Dutch.
Must have a friend or family member available to accompany them home after treatment.

Who Cannot Join the Study?

Patients who are currently using any other experimental drugs or treatments.
Individuals with a history of severe mental health disorders, such as schizophrenia or bipolar disorder.
Patients who have had a recent heart attack or have severe heart disease.
Individuals with uncontrolled high blood pressure.
Patients who are pregnant or breastfeeding.
Individuals with a history of substance abuse or addiction.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate.
Individuals who have participated in another clinical trial within the last 30 days.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Afcyojgum Ulb	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	06.01.2025

Trial locations

Investigated drugs:

Psilocybin is being studied as a new treatment for patients who have chronic nerve pain caused by chemotherapy. The goal is to see if it can help reduce the impact of pain on daily activities.

Investigated diseases:

Chemotherapy-Induced Peripheral Neuropathy – This condition occurs as a side effect of certain chemotherapy drugs, leading to nerve damage. It typically manifests as tingling, numbness, or pain in the hands and feet. The symptoms can start during or after chemotherapy and may worsen over time. Patients often experience difficulties with balance and coordination. The severity of symptoms can vary, and they may persist long after treatment ends. This condition can significantly impact daily activities and quality of life.

Chronic Neuropathic Pain – This type of pain results from damage to the nerves, often described as burning, shooting, or stabbing sensations. It can arise from various causes, including injury, infection, or underlying health conditions. Unlike acute pain, which serves as a warning of injury, chronic neuropathic pain persists beyond the usual healing time. It can be constant or intermittent and may be accompanied by sensitivity to touch or temperature changes. This pain can interfere with sleep, mood, and overall functioning. Managing daily activities can become challenging due to the persistent discomfort.

Trial ID:

2024-516936-93-02

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Psilocybin for Relieving Chronic Neuropathic Pain in Patients with Chemotherapy-Induced Peripheral Neuropathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?