Soothing Pain After ChEmotherapy: Psilocybin As INtervention (SPACE-PAIN) — a randomized controlled pilot trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Nervous System Diseases [C10]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2024-12-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

KWF Dutch Cancer Society

External identifiers

EU CT number

2024-516936-93-02

WHO UTN

U1111-1302-8649

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

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.

Conditions and MedDRA coding

chemotherapy-induced peripheral neuropathy, chronic neuropathic pain

Regulatory references

Plan to share IPD

Yes

IPD plan description

Data will be made available upon reasonable request following the completion of the trial and publication of the final manuscript. The shared data may include de-identified data that contains individual-level data collected during the trial. Researchers seeking data access must submit a research proposal and analysis plan outlining objectives, methodology, and relevance. If applicable, approval by a medical ethics research committee is required. Proposals will be reviewed to ensure that the request aligns with scientific and ethical standards, and data access will be granted under a data use/sharing agreement that stipulates the terms and conditions for data usage.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Adult (at least 18 years old)
2. Chronic neuropathic pain after chemotherapy
3. Inclusion at least six months after diagnosis of chemotherapy-induced peripheral neuropathy, as determined by the clinical investigator
4. 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
5. A stable pain treatment regimen before inclusion (no changes in pain medication for at least two weeks prior)
6. Able to read/write/understand Dutch
7. Availability of a friend or family member who can accompany the patient home after treatment

Exclusion criteria 15

1. A personal or first-degree relative history of schizophrenia spectrum or other psychotic disorders including bipolar disorders
2. Use of a monoamine oxidase inhibitor and/or lithium
3. 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.
4. Pregnancy and/or breastfeeding
5. A psychedelic experience with a classic psychedelic (psilocybin, LSD, mescaline, or DMT/ayahuasca) in the past year
6. Known allergy or intolerance to psilocybin
7. Documented alcohol or drugs abuse and/or based on clinical opinion of the treating physician
8. Uncontrolled hypertension with a documented systolic blood pressure >180 mmHg
9. Planned surgery during the trial period
10. Incapacitated without decision-making capacity according to the treating physician
11. 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)
12. Active suicidal intent, defined by a score>3 on the C-SSRS
13. Any doubt on active drugs or alcohol use at the day of the intervention as judged by the supervising therapist
14. Any doubts about patient alcohol or drugs abuse or increased risk of relapse as judged by the supervising therapist after the psychological safety evaluation
15. Any doubts about patient safety as judged by the supervising therapist after the psychological safety evaluation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Patient recruitment and retention rates, and completeness of outcome data. We will also assess which factors impact participation. Based on this, barriers to recruitment can be identified and addressed.
2. Patient expectancy, measured with the 6-item Dutch Stanford Expectations of Treatment Scale (SETS).
3. Assessment of mystical experience, measured with the 30-item Mystical Experience Questionnaire (MEQ).
4. Assessment of emotional breakthrough, measured with the 6-item Emotional Breakthrough Inventory (EBI).
5. Assessment of psychological insight, measured with the 7-item Psychological Insight Scale (PIS).
6. Blinding success.
7. Adverse events, reported by patient or observed by study staff.

Secondary endpoints 15

1. Pain interference, measured with the 8-item PROMIS Pain Interference Short Form v1.1 8a.
2. Current pain intensity, measured with the single-item Numeric Rating Scale (NRS).
3. Average pain intensity in the last 24 hours, measured with the single-item Numeric Rating Scale (NRS).
4. Pain catastrophizing, measured with the 13-item Pain Catastrophizing Scale (PCS).
5. Current pain medication use, including opioids in morphine-equivalents. Extracted from the electronic health record or collected via interview.
6. Physical function, measured with the 6-item PROMIS Physical Function Short Form v2.0 6b.
7. Sleep disturbance, measured with the 6-item PROMIS Sleep Disturbance Short Form v1.0 6a.
8. Depression, measured with the 6-item PROMIS Depression Short Form v1.0 6a.
9. Anxiety, measured with the 6-item PROMIS Anxiety Short Form v1.0 6a.
10. Fatigue, measured with the 6-item PROMIS Fatigue Short Form v1.0 6a.
11. Satisfaction with social roles, measured with the 6-item PROMIS Satisfaction with Social Roles Short Form v2.0 6a.
12. CIPN-related quality of life, measured with the 20-item EORTC-QLQ-CIPN20.
13. Cancer-related quality of life, measured with the 30-item EORTC-QLQ-C30.
14. Health-related quality of life, measured with the 5-item EQ5D.
15. Global perceived effect, measured with the 2-item Global Perceived Effect (GPE).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

clinical trial information desk

Public contact point

Organisation

Amsterdam UMC

Contact name

clinical trial information desk

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 37 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications