Psilocybin and Affective Function in Chronic Lower Back Pain and Depression
裸盖菇素与慢性腰痛和抑郁症的情感功能
基本信息
- 批准号:10626449
- 负责人:
- 金额:$ 47.87万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-08-25 至 2026-04-30
- 项目状态:未结题
- 来源:
- 关键词:AddressAffectAffectiveAftercareAmygdaloid structureAttenuatedChronic low back painClinicalClinical TrialsCognitiveDataDoseDouble-Blind MethodEcological momentary assessmentFaceFutureGuidelinesHallucinogensIndividualInterventionLaboratoriesLeadLifeMajor Depressive DisorderMalignant NeoplasmsMediatingMedicineMental DepressionModalityMonitorOutcomePainPain intensityPain managementPatientsPlacebosPopulationPositioning AttributeProcessPsilocybinRandomized, Controlled TrialsReportingResearchRiskRitalinSafetySamplingScienceSensorySerotonin Receptor 5-HT2AStimulusSupervisionSymptomsTestingTreatment EfficacyUnited States National Institutes of HealthWorkactive controlanxiety symptomscancer diagnosischronic painchronic pain patientchronic painful conditioncomorbid depressioncomorbiditycopingdepressive symptomsdisabilityefficacy trialfollow-upfunctional improvementimprovedinnovationinsightnegative affectnon-opioid analgesicpain catastrophizingpain inhibitionpain symptomprimary outcomeresponseruminationsecondary analysistreatment durationtreatment guidelinestrial comparing
项目摘要
PROJECT SUMMARY/ABSTRACT
This R33 application proposes a mechanistic clinical trial testing the effects of psilocybin on affective
mechanisms of chronic pain in patients with comorbid chronic low back pain and depression (CLBP+D). CLBP
is the top cause of disability worldwide, and is highly comorbid with depression. Patients with CLBP+D face a
fragmented and limited set of treatment options that insufficiently address their pain and depression symptoms.
As such, CLBP treatment guidelines call for a shift away from a sole outcome focus on pain intensity and
toward treatments that enhance affective function. Positive and negative affect, pain catastrophizing, and
positive affective pain inhibition are well-characterized, modifiable, biologically-mediated mechanisms of
chronic pain that we propose to target in this study of patients with CLBP+D. Psilocybin, a classic (5-HT2A
receptor-mediated) psychedelic, is a promising non-opioid candidate for the treatment of CLBP+D that reliably
and durably improves affective function in healthy individuals, patients with major depressive disorder, and
patients with a life-threatening cancer diagnosis. We aim to test whether psilocybin will benefit patients with
CLBP+D by durably improving positive affect, negative affect, and pain catastrophizing, and augmenting the
ability of positive affect to inhibit pain. The proposed study addresses an important unmet need, as it will be the
first, to our knowledge, to test the ability of psilocybin to target pain-related affective function in patients with
chronic pain. We propose a double-blind, randomized, controlled trial comparing the administration of high-
dose psilocybin (25mg absolute dose; n=20) to an active control (methylphenidate 40mg absolute dose; n=20)
among patients with CLBP+D. Psilocybin or methylphenidate will be administered once in the laboratory under
close supervision and supportive monitoring. Primary outcomes will be positive and negative affect (Aim 1),
pain catastrophizing (Aim 2), and positive affective pain inhibition (Aim 3). Ecological momentary assessment
will be used to evaluate the hypotheses that aggregated momentary reports of positive and negative affect and
pain catastrophizing will improve from baseline to 1-week post-session to a greater extent in patients in the
psilocybin versus the methylphenidate condition. Quantitative sensory testing will be used to evaluate the
hypothesis that positive affective pain inhibition will increase from baseline to 1-week post-session to a greater
extent in patients in the psilocybin versus the methylphenidate condition. The durability of outcomes will be
tested at 1-month post-administration in secondary analyses. By testing the effects of psilocybin on affective
function in CLBP+D, we will develop critical data that will provide mechanistic insight into the utility of
psilocybin as a pain management medicine. These data will build off our extensive preliminary findings in
support of psilocybin’s efficacy for major depressive disorder, and pave the way for future pivotal efficacy trials
for psilocybin as a primary treatment for patients with CLBP+D.
项目概要/摘要
该 R33 申请提出了一项机械临床试验,测试裸盖菇素对情感的影响
慢性腰痛和抑郁症 (CLBP+D) 患者的慢性疼痛机制。
CLBP+D 是全球残疾的首要原因,并且与抑郁症高度共存。
零碎且有限的治疗方案不足以解决他们的疼痛和抑郁症状。
因此,CLBP 治疗指南呼吁改变仅仅关注疼痛强度和
针对增强情感功能、疼痛灾难性的治疗。
积极的情感性疼痛抑制是特征明确的、可改变的、生物介导的机制
我们建议在这项针对 CLBP+D 患者的研究中针对慢性疼痛,这是一种经典药物 (5-HT2A)。
受体介导的)迷幻剂,是一种有前途的非阿片类药物候选药物,用于治疗 CLBP+D,可靠
并持久改善健康个体、重度抑郁症患者的情感功能,以及
我们的目标是测试裸盖菇素是否对患有危及生命的癌症的患者有益。
CLBP+D 通过持久改善积极情感、消极情感和灾难性疼痛,并增强
拟议的研究解决了一个重要的未满足的需求,因为它将是
首先,据我们所知,测试裸盖菇素针对患有以下疾病的患者的疼痛相关情感功能的能力:
我们提出了一项双盲、随机、对照试验,比较高剂量的给药。
将裸盖菇素剂量(25mg 绝对剂量;n=20)给予活性对照(哌醋甲酯 40mg 绝对剂量;n=20)
在 CLBP+D 患者中,将在实验室中给予裸盖菇素或哌醋甲酯一次。
密切监督和支持性监测将产生积极和消极影响(目标 1),
疼痛灾难化(目标 2)和积极的情感疼痛抑制(目标 3)。
将用于评估汇总正面和负面影响的瞬时报告的假设
患者的疼痛灾难化程度将从基线到治疗后 1 周得到更大程度的改善
将使用裸盖菇素与哌甲酯条件进行定量感官测试来评估。
假设积极的情感疼痛抑制将从基线到治疗后 1 周增加到更大
裸盖菇素治疗与哌醋甲酯治疗患者的结果的持久性程度。
给药后 1 个月进行二次分析,测试裸盖菇素对情感的影响。
CLBP+D 中的功能,我们将开发关键数据,为 CLBP+D 的效用提供机制洞察
这些数据将建立在我们广泛的初步研究结果的基础上。
支持裸盖菇素对重度抑郁症的疗效,并为未来的关键疗效试验铺平道路
裸盖菇素作为 CLBP+D 患者的主要治疗方法。
项目成果
期刊论文数量(0)
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Patrick Finan其他文献
Patrick Finan的其他文献
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