DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: METHANOL for Chemotherapy-induced peripheral neuropathy|Chronic neuropathic pain

Inclusion criteria

• {"criterion_text":"- Adult (at least 18 years old)\n- Chronic neuropathic pain after chemotherapy\n- Inclusion at least six months after diagnosis of chemotherapy-induced peripheral neuropathy, as determined by the clinical investigator\n- 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\n- A stable pain treatment regimen before inclusion (no changes in pain medication for at least two weeks prior)\n- Able to read/write/understand Dutch\n- Availability of a friend or family member who can accompany the patient home after treatment"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- 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.\n- Patient expectancy, measured with the 6-item Dutch Stanford Expectations of Treatment Scale (SETS).\n- Assessment of mystical experience, measured with the 30-item Mystical Experience Questionnaire (MEQ).\n- Assessment of emotional breakthrough, measured with the 6-item Emotional Breakthrough Inventory (EBI).\n- Assessment of psychological insight, measured with the 7-item Psychological Insight Scale (PIS).\n- Blinding success.\n- Adverse events, reported by patient or observed by study staff.","definition_or_measurement_approach":"- Patient recruitment and retention rates, and completeness of outcome data: assessed by recording recruitment and retention metrics and completeness of collected outcomes (no additional measurement instrument specified).\n- Patient expectancy: measured with the 6-item Dutch Stanford Expectations of Treatment Scale (SETS).\n- Mystical experience: measured with the 30-item Mystical Experience Questionnaire (MEQ).\n- Emotional breakthrough: measured with the 6-item Emotional Breakthrough Inventory (EBI).\n- Psychological insight: measured with the 7-item Psychological Insight Scale (PIS).\n- Blinding success: assessed (method not further specified in the provided data).\n- Adverse events: reported by patient or observed by study staff (safety monitoring via AE reporting)."}

Secondary endpoints

• {"endpoint_text":"- Pain interference, measured with the 8-item PROMIS Pain Interference Short Form v1.1 8a.\n- Current pain intensity, measured with the single-item Numeric Rating Scale (NRS).\n- Average pain intensity in the last 24 hours, measured with the single-item Numeric Rating Scale (NRS).\n- Pain catastrophizing, measured with the 13-item Pain Catastrophizing Scale (PCS).\n- Current pain medication use, including opioids in morphine-equivalents. Extracted from the electronic health record or collected via interview.\n- Physical function, measured with the 6-item PROMIS Physical Function Short Form v2.0 6b.\n- Sleep disturbance, measured with the 6-item PROMIS Sleep Disturbance Short Form v1.0 6a.\n- Depression, measured with the 6-item PROMIS Depression Short Form v1.0 6a.\n- Anxiety, measured with the 6-item PROMIS Anxiety Short Form v1.0 6a.\n- Fatigue, measured with the 6-item PROMIS Fatigue Short Form v1.0 6a.\n- Satisfaction with social roles, measured with the 6-item PROMIS Satisfaction with Social Roles Short Form v2.0 6a.\n- CIPN-related quality of life, measured with the 20-item EORTC-QLQ-CIPN20.\n- Cancer-related quality of life, measured with the 30-item EORTC-QLQ-C30.\n- Health-related quality of life, measured with the 5-item EQ5D.\n- Global perceived effect, measured with the 2-item Global Perceived Effect (GPE).","definition_or_measurement_approach":"- Pain interference: measured with the 8-item PROMIS Pain Interference Short Form v1.1 8a.\n- Current pain intensity: measured with the single-item Numeric Rating Scale (NRS).\n- Average pain intensity in the last 24 hours: measured with the NRS.\n- Pain catastrophizing: measured with the 13-item Pain Catastrophizing Scale (PCS).\n- Current pain medication use: captured from EHR or interview, opioids converted to morphine-equivalents.\n- Physical function: measured with PROMIS Physical Function Short Form v2.0 6b.\n- Sleep disturbance: measured with PROMIS Sleep Disturbance Short Form v1.0 6a.\n- Depression: measured with PROMIS Depression Short Form v1.0 6a.\n- Anxiety: measured with PROMIS Anxiety Short Form v1.0 6a.\n- Fatigue: measured with PROMIS Fatigue Short Form v1.0 6a.\n- Satisfaction with social roles: measured with PROMIS Satisfaction with Social Roles Short Form v2.0 6a.\n- CIPN-related QoL: measured with EORTC-QLQ-CIPN20.\n- Cancer-related QoL: measured with EORTC-QLQ-C30.\n- Health-related QoL: measured with EQ-5D (5-item).\n- Global perceived effect: measured with the 2-item GPE."}

Netherlands

Earliest CTIS Part Ii Submission Date

01-11-2024

Latest Decision Or Authorization Date

08-01-2025

Processing Time Days

68

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands