EFFICACY OF LOW DOSE NALTREXONE THERAPY IN CROHN'S DISEASE

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。本研究将评估纳曲酮治疗克罗恩病的疗效。研究人员将评估小剂量纳曲酮对30名克罗恩病患者克罗恩病活动指数(CDAI)的影响。受试者将接受小剂量纳曲酮(4.5 mg，qd，P.O.)治疗。已经12周了。每月测量的临床终点将包括CDAI和生活质量问卷。临床反应定义为CDAI下降70分，临床缓解定义为下降150分。这项研究还将获得数据，以评估小剂量纳曲酮在克罗恩病患者中的安全性和毒性，并确定其对血浆脑啡肽水平的影响。

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 study will evaluate the efficacy of naltrexone in treatment of patients with Crohn's disease. The investigators will evaluate the effect of low dose naltrexone on the Crohn's disease Activity Index (CDAI) in 30 patients with poorly controlled Crohn's disease (CDAI score > 220). Subjects will be treated with low dose Naltrexone (4.5 mg qd p.o.) for 12 weeks. Measured clinical endpoints obtained at monthly intervals will include the CDAI and quality of life questionnaires. A clinical response will be defined as a fall in the CDAI of 70 points, and a clinical remission as a decrease of 150 points. This study will also acquire data to evaluate the safety and toxicity of low dose Naltrexone in Crohn's patients, and determine the effect on plasma enkephalin levels.