EFFICACY OF LOW DOSE NALTREXONE THERAPY IN CROHN'S DISEASE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究将评价纳曲酮治疗克罗恩病患者的疗效。研究人员将评估低剂量纳曲酮对30例克罗恩病控制不佳（CDAI评分为bb0 220）患者克罗恩病活动指数（CDAI）的影响。受试者将接受低剂量纳曲酮治疗（每天4.5 mg），持续12周。以每月为间隔获得的测量临床终点包括CDAI和生活质量问卷。临床缓解被定义为CDAI下降70分，临床缓解被定义为减少150分。本研究还将获取数据，评估低剂量纳曲酮对克罗恩病患者的安全性和毒性，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.