Psilocybin Therapy for Advanced Cancer-related Psychiatric Distress

裸盖菇素治疗晚期癌症相关精神困扰

基本信息

批准号：
10659059
负责人：
STACY M FISCHER
金额：
$ 65.16万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-04 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10659059
关键词：
Acute Address Adjustment Disorders Advanced Malignant Neoplasm Adverse effects Affect Antidepressive Agents Anxiety Anxiety Disorders Attention Behavior Behavior Therapy Cancer Patient Cessation of life Clinical Clinical Research Cognition Cognitive Data Distress Dose Double-Blind Method Effectiveness Emotional Ensure Environment Evidence based intervention Feeling hopeless Foundations Goals Hallucinogens Health Hour Human Integrative Therapy Intervention Life Long-Term Depression Long-Term Effects Major Depressive Disorder Malignant Neoplasms Manuals Measures Mental Depression Mental Health Mental disorders Mind Moods Outcome Outcome Study Pain Participant Patient Care Patient Self-Report Patients Personal Satisfaction Personality Traits Persons Pharmaceutical Preparations Physiological Placebo Control Placebos Preparation Prevalence Psilocybin Psychotherapy Public Health Quality of life Randomized Randomized, Controlled Trials Relapse Research SEER Program Safety Sampling Science Site Spirituality Survival Rate Testing Therapeutic Therapeutic Uses Time Treatment Efficacy Treatment Protocols Tryptamines Work cancer care cancer diagnosis cancer survival cancer therapy clinical care clinically significant common treatment completed suicide death anxiety design disability dysphoria effective therapy efficacy evaluation emotional distress experience flexibility follow-up improved innovation life-limiting cancer medication compliance medication nonadherence mental state mortality novel therapeutic intervention open label peace pharmacologic placebo group psychiatric comorbidity psychologic psychosocial response success trait

项目摘要

Project Summary/ Abstract An estimated 30-40% of cancer patients experience clinically significant anxiety and depression. The burden of suffering caused by psychiatric distress has profound negative impacts on quality of life (QOL), medication adherence, increased rates of completed suicide, and even decreased cancer survival rates. Approximately 25% of cancer patients with advanced or terminal cancer experience clinically significant existential distress characterized by demoralization, hopelessness, absence of purpose or meaning, loss of dignity, and hastened desire for death. Pharmacologic and psychosocial treatments are commonly used to treat depression, anxiety and existential distress in cancer patients, but their effectiveness is limited and mixed. Psilocybin is a psychedelic tryptamine with a good physiologic-psychological safety profile in human lab and clinical research, producing highly salient meaningful experiences, often described as spiritual/mystical states of mind, associated with enduring (months to years) positive changes in cognition, affect, behavior, and spirituality. Based on extensive preliminary data, psilocybin-assisted therapy has demonstrated both safety and preliminary efficacy to improve cancer-related depression and anxiety (effect size = 0.82-1.69), and existential distress while improving quality of life, Participants in preliminary trials found the experience to be both acceptable and highly meaningful and spiritual. Building on this strong foundation of preliminary work, we propose to conduct a two-site, active placebo-controlled, double-blind, parallel design, randomized controlled trial of single high dose psilocybin-assisted therapy versus active placebo (very low dose psilocybin) for 200 participants with advanced cancer and baseline psychiatric distress. All participants will receive preparatory, active dosing, and integrative therapy sessions as part of the psilocybin and active placebo groups. We propose to conduct the following aims: 1) To assess the short- and long-term effects of psilocybin on mental health (e.g. anxiety, depression, existential distress) outcomes; 2) To assess the effects of psilocybin on QOL; and 3) To evaluate the contribution of psilocybin-induced psychological change mechanisms (mystical experience, personality trait openness, cognitive flexibility) on acute and long-term mental health outcomes (depression, anxiety, existential distress). We will collect baseline measures and follow up of outcomes at 1 day, 1 week, 8 weeks, 12 weeks, and 24 weeks (6 months). The proposed study will impact clinical care for persons with advanced cancer by testing an innovative, evidence-based intervention to improve depression, anxiety, existential distress, and quality of life. The study is significant because it addresses important mental health domains of suffering in patients with life-limiting cancer. The study is innovative as the potentially first effective therapy to impact existential distress. Furthermore, this study will further the science by evaluating the psychological change mechanisms for this promising new therapeutic intervention.

项目概要/摘要据估计，30-40% 的癌症患者会经历临床上明显的焦虑和抑郁。的负担精神困扰造成的痛苦对生活质量（QOL）、药物治疗产生深远的负面影响依从性，自杀完成率增加，甚至癌症存活率下降。大约 25% 的晚期或晚期癌症患者经历临床上显着的生存困扰其特点是士气低落、绝望、缺乏目的或意义、丧失尊严、加速对死亡的渴望。药物和心理社会治疗通常用于治疗抑郁症、焦虑症和癌症患者的生存困扰，但其效果有限且好坏参半。赛洛西宾是一种迷幻色胺在人体实验室和临床研究中具有良好的生理心理安全性，产生高度显着的有意义的体验，通常被描述为精神/神秘的心态，与认知、情感、行为和灵性方面持久（数月至数年）的积极变化相关。基于广泛的初步数据，裸盖菇素辅助疗法已证明安全性和改善癌症相关抑郁和焦虑的初步功效（效果大小 = 0.82-1.69），以及存在主义初步试验的参与者发现，这种体验既能改善生活质量，又能缓解痛苦可以接受，并且非常有意义和精神。在前期工作的坚实基础上，我们建议进行两中心、主动安慰剂对照、双盲、平行设计、随机对照单次高剂量裸盖菇素辅助治疗与活性安慰剂（极低剂量裸盖菇素）的试验，为期 200 次患有晚期癌症和基线精神困扰的参与者。所有参与者都将收到准备，作为裸盖菇素组和活性安慰剂组的一部分，积极给药和综合治疗。我们建议实现以下目标： 1) 评估裸盖菇素对精神的短期和长期影响健康（例如焦虑、抑郁、存在痛苦）结果； 2) 评估裸盖菇素对生活质量的影响； 3）评估裸盖菇素引起的心理变化机制（神秘的经验、人格特质开放性、认知灵活性）对短期和长期心理健康结果的影响（抑郁、焦虑、存在主义困扰）。我们将在 1 时收集基线措施并跟踪结果天、1周、8周、12周和24周（6个月）。拟议的研究将影响临床护理通过测试一种创新的、基于证据的干预措施来改善抑郁症患者，焦虑、生存困扰和生活质量。这项研究意义重大，因为它解决了重要的心理问题限制生命的癌症患者所遭受的健康痛苦。该研究具有创新性，可能是第一个影响存在痛苦的有效疗法。此外，这项研究将通过评估这种有希望的新治疗干预的心理变化机制。