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 i s 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.
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