EFFECTS OF PSILOCYBIN IN TERMINAL CANCER PATIENTS WITH ANXIETY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项临床研究，重点是管理身体和心理症状，以提高生命接近尾声的人的生活质量。具体目的是了解迷幻剂裸盖菇素是否能有效地减轻晚期癌症患者的焦虑、抑郁和身体疼痛，并提高他们的生活质量。12名患有癌症和焦虑症的成年受试者将接受筛查，并给予知情同意。这项先导性研究是一项交叉设计的双盲、安慰剂对照研究。所有受试者将在一个疗程中接受0.2 mg/kg的裸盖菇素治疗，并在六周后的第二个疗程中随机接受250 mg烟酸的活性安慰剂。首席调查员和硕士级别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。疗效将通过各种前后措施进行评估，检查焦虑、抑郁、疼痛和生活质量。 这项研究的意义在于，它解决了生命末期的心理和精神健康这一重要问题。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，题为《改善癌症姑息治疗：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“考虑试验治疗精神情感症状的新药”(Foley和Gelband，2001)。 除了目前用于晚期癌症姑息治疗的传统心理疗法和精神药物治疗方案外，在20世纪60年代开发了一种模式，使用迷幻剂来集中处理和治疗患有严重临终医学疾病的个人的核心心理过程。在此期间的调查表明，当在批准和严格控制的条件下进行临床致幻剂研究时，确定具有可接受的安全参数。

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.