EFFICACY OF LOW DOSE NALTREXONE THERAPY IN CROHN'S DISEASE

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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.