Low-Dose Naltrexone Therapy Improves Active Crohn’s Disease

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Low-Dose Naltrexone Therapy Improves Active Crohn’s DiseaseJill P. Smith, M.D.,1 Heather Stock, M.D.,1 Sandra Bingaman, R.N.,1 David Mauger, Ph.D.,2Moshe Rogosnitzky,3 and Ian S. Zagon, Ph.D.4
Departments of 1Medicine and 2Health Evaluation Sciences, Pennsylvania State University College of Medicine, Hershey, Pennsylvania; 3Consultant, Telz Stone, Israel; and 4Neural and Behavioral Sciences, Pennsylvania State University, Hershey, Pennsylvania
OBJECTIVES: Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair oftissues. In an open-labeled pilot prospective trial, the safety and efficacy of low-dose naltrexone(LDN), an opioid antagonist, were tested in patients with active Crohn’s disease.
METHODS: Eligible subjects with histologically and endoscopically confirmed active Crohn’s disease activityindex (CDAI) score of 220–450 were enrolled in a study using 4.5 mg naltrexone/day. Infliximabwas not allowed for a minimum of 8 wk prior to study initiation. Other therapy for Crohn’s diseasethat was at a stable dose for 4 wk prior to enrollment was continued at the same doses. Patientscompleted the inflammatory bowel disease questionnaire (IBDQ) and the short-form (SF-36) qualityof life surveys and CDAI scores were assessed pretreatment, every 4 wk on therapy and 4 wk aftercompletion of the study drug. Drug was administered by mouth each evening for a 12-wk period.
RESULTS: Seventeen patients with a mean CDAI score of 356 ± 27 were enrolled. CDAI scores decreasedsignificantly (P = 0.01) with LDN, and remained lower than baseline 4 wk after completing therapy.Eighty-nine percent of patients exhibited a response to therapy and 67% achieved a remission(P < 0.001). Improvement was recorded in both quality of life surveys with LDN compared withbaseline. No laboratory abnormalities were noted. The most common side effect was sleepdisturbances, occurring in seven patients.
CONCLUSIONS: LDN therapy appears effective and safe in subjects with active Crohn’s disease. Further studies areneeded to explore the use of this compound.(Am J Gastroenterol 2007;102:820–828)