Soothing Pain After ChEmotherapy: Psilocybin As INtervention (SPACE-PAIN) — a randomized controlled pilot trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
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.
Patient expectancy, measured with the 6-item Dutch Stanford Expectations of Treatment Scale (SETS).
Patient expectancy, measured with the 6-item Dutch Stanford Expectations of Treatment Scale (SETS).
Assessment of mystical experience, measured with the 30-item Mystical Experience Questionnaire (MEQ).
Assessment of mystical experience, measured with the 30-item Mystical Experience Questionnaire (MEQ).
Assessment of emotional breakthrough, measured with the 6-item Emotional Breakthrough Inventory (EBI).
Assessment of emotional breakthrough, measured with the 6-item Emotional Breakthrough Inventory (EBI).
Assessment of psychological insight, measured with the 7-item Psychological Insight Scale (PIS).
Assessment of psychological insight, measured with the 7-item Psychological Insight Scale (PIS).
Blinding success.
Blinding success.
Adverse events, reported by patient or observed by study staff.
Adverse events, reported by patient or observed by study staff.
次要结局
- Health-related quality of life, measured with the 5-item EQ5D.
- Cancer-related quality of life, measured with the 30-item EORTC-QLQ-C30.
- Pain interference, measured with the 8-item PROMIS Pain Interference Short Form v1.1 8a.
- Current pain intensity, measured with the single-item Numeric Rating Scale (NRS).
- Average pain intensity in the last 24 hours, measured with the single-item Numeric Rating Scale (NRS).
- Pain catastrophizing, measured with the 13-item Pain Catastrophizing Scale (PCS).
- Current pain medication use, including opioids in morphine-equivalents. Extracted from the electronic health record or collected via interview.
- Physical function, measured with the 6-item PROMIS Physical Function Short Form v2.0 6b.
- Sleep disturbance, measured with the 6-item PROMIS Sleep Disturbance Short Form v1.0 6a.
- Depression, measured with the 6-item PROMIS Depression Short Form v1.0 6a.
- Anxiety, measured with the 6-item PROMIS Anxiety Short Form v1.0 6a.
- Fatigue, measured with the 6-item PROMIS Fatigue Short Form v1.0 6a.
- Satisfaction with social roles, measured with the 6-item PROMIS Satisfaction with Social Roles Short Form v2.0 6a.
- CIPN-related quality of life, measured with the 20-item EORTC-QLQ-CIPN20.
- Global perceived effect, measured with the 2-item Global Perceived Effect (GPE).
研究者
clinical trial information desk
Scientific
Amsterdam UMC