BridgeMD
Soothing Pain After ChEmotherapy: Psilocybin As INtervention (SPACE-PAIN) — a randomized controlled pilot trial
EU CTIS ID: 2024-516936-93-02
What this study is testing
Our primary objective is to assess feasibility and preliminary efficacy of psilocybin as a novel therapy for patients with chemotherapy-induced chronic neuropathic pain, specifically to improve pain-related interference with daily functioning.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult (at least 18 years old)
- Chronic neuropathic pain after chemotherapy
- Inclusion at least six months after diagnosis of chemotherapy-induced peripheral neuropathy, as determined by the clinical investigator
- A self-reported average pain intensity of at least 4 on the 11-point Numeric Rating Scale (0=no pain to 10=worst pain imaginable) the week before assessment of inclusion criteria
- A stable pain treatment regimen before inclusion (no changes in pain medication for at least two weeks prior)
- Able to read/write/understand Dutch
You likely can't join if
- A personal or first-degree relative history of schizophrenia spectrum or other psychotic disorders including bipolar disorders
- Incapacitated without decision-making capacity according to the treating physician
- Probable post-traumatic stress disorder (PTSD), defined by a score>33 on the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (PCL-5)
- Active suicidal intent, defined by a score>3 on the C-SSRS
- Any doubt on active drugs or alcohol use at the day of the intervention as judged by the supervising therapist
- Any doubts about patient alcohol or drugs abuse or increased risk of relapse as judged by the supervising therapist after the psychological safety evaluation
See the full eligibility criteria
- Adult (at least 18 years old)
- Chronic neuropathic pain after chemotherapy
- Inclusion at least six months after diagnosis of chemotherapy-induced peripheral neuropathy, as determined by the clinical investigator
- A self-reported average pain intensity of at least 4 on the 11-point Numeric Rating Scale (0=no pain to 10=worst pain imaginable) the week before assessment of inclusion criteria
- A stable pain treatment regimen before inclusion (no changes in pain medication for at least two weeks prior)
- Able to read/write/understand Dutch
- Availability of a friend or family member who can accompany the patient home after treatment
- A personal or first-degree relative history of schizophrenia spectrum or other psychotic disorders including bipolar disorders
- Incapacitated without decision-making capacity according to the treating physician
- Probable post-traumatic stress disorder (PTSD), defined by a score>33 on the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (PCL-5)
- Active suicidal intent, defined by a score>3 on the C-SSRS
- Any doubt on active drugs or alcohol use at the day of the intervention as judged by the supervising therapist
- Any doubts about patient alcohol or drugs abuse or increased risk of relapse as judged by the supervising therapist after the psychological safety evaluation
- Any doubts about patient safety as judged by the supervising therapist after the psychological safety evaluation
- Use of a monoamine oxidase inhibitor and/or lithium
- Use of clinically relevant known UDP-glucuronosyltransferase (UGT) enzyme modulators. This includes anti-epileptics (such as valproate, phenytoin, and lamotrigine, but specifically not including pregabalin) and rifampicin.
- Pregnancy and/or breastfeeding
- A psychedelic experience with a classic psychedelic (psilocybin, LSD, mescaline, or DMT/ayahuasca) in the past year
- Known allergy or intolerance to psilocybin
- Documented alcohol or drugs abuse and/or based on clinical opinion of the treating physician
- Uncontrolled hypertension with a documented systolic blood pressure >180 mmHg
- Planned surgery during the trial period
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.