EFFECTS OF PSILOCYBIN IN TERMINAL CANCER PATIENTS WITH ANXIETY

裸盖菇素对晚期癌症患者焦虑的影响

• 批准号: 7376066
• 负责人: CHARLES GROB
• 金额: $ 1万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376066
• 关键词: EFFECTS; PSILOCYBIN; TERMINAL; CANCER; PATIENTS

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a clinical study focused on management of physical and psychological symptoms to enhance the quality of life remaining for individuals who are nearing the end of their lives. The specific aim is to learn whether the hallucinogen, psilocybin, might be effective in reducing anxiety, depression and physical pain, and improving the quality of life in terminal cancer patients. 12 adult subjects with cancer with projected survival up to one year and anxiety disorder will be screened and given informed consent. This pilot investigation is a double-blind, placebo-controlled study with a crossover design. All subjects will receive 0.2 mg/kg of psilocybin during one treatment session and an active placebo, 250 mg of niacin, during a second session six weeks later, in a randomized sequence. The principal investigator and a master's level psychotherapist or nurse will remain with the subject until the effects of the drug have subsided. Efficacy will be evaluated by a variety of pre- and post-measures examining anxiety, depression, pain and quality of life. The significance of this study is that it addresses the important problem of the psychological and spiritual well being at the end of life. The National Cancer Policy Board of the Institute of Medicine and National Research Council issued a report in 2001, "Improving Palliative Care for Cancer: Summary and Recommendations." The report called for more research and treatment for palliative care of cancer patients, and one of the specific recommendations was to "consider trials of novel agents" for psychiatric affective symptoms (Foley and Gelband, 2001). In addition to conventional psychotherapies and psychotropic medication regimens used in palliative care for terminal cancer today, a model was developed in the 1960s for using hallucinogens to intensively address and treat the core psychological processes of individuals inflicted with drastic, end of life medical illnesses. Investigations during this period demonstrated that when conducted under sanctioned and tightly controlled conditions, clinical hallucinogen research was determined to possess acceptable safety parameters.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项临床研究，重点是管理身体和心理症状，以提高接近生命尽头的个人的生活质量。具体目的是了解致幻剂psilocybin是否可以有效减少焦虑，抑郁和身体疼痛，并改善晚期癌症患者的生活质量。将筛选12例预计生存期长达1年的癌症和焦虑症成人受试者，并给予知情同意。本初步研究是一项交叉设计的双盲、安慰剂对照研究。所有受试者将在一次治疗期间接受0.2 mg/kg的裸盖菇素，并在六周后的第二次治疗期间接受250 mg烟酸的活性安慰剂。主要研究者和硕士水平的心理治疗师或护士将留在受试者身边，直到药物的影响消退。将通过检查焦虑、抑郁、疼痛和生活质量的各种治疗前和治疗后措施来评价疗效。 这项研究的意义在于它解决了生命结束时心理和精神健康的重要问题。医学研究所和国家研究理事会的国家癌症政策委员会在2001年发布了一份报告，“改善癌症的姑息治疗：总结和建议。该报告呼吁对癌症患者的姑息治疗进行更多的研究和治疗，其中一项具体建议是“考虑对精神情感症状进行新药物试验”（Foley和Gelband，2001）。 除了传统的心理疗法和精神药物治疗方案用于姑息治疗晚期癌症，在20世纪60年代开发了一种模型，用于使用致幻剂来集中解决和治疗患有严重的生命末期医学疾病的个人的核心心理过程。在此期间的研究表明，当在批准和严格控制的条件下进行时，临床致幻剂研究被确定为具有可接受的安全参数。