Original Contribution
The American Journal of Gastroenterology (2007) 102, 820–828; doi:10.1111/j.1572-0241.2007.01045.x
Low-Dose Naltrexone Therapy Improves Active Crohn's Disease
Jill P Smith MD1, Heather Stock MD1, Sandra Bingaman RN1, David Mauger PhD2, Moshe Rogosnitzky3 and Ian S Zagon PhD4
- 1Departments of Medicine, Pennsylvania State University College of Medicine, Hershey, Pennsylvania
- 2Departments of Health Evaluation Sciences, Pennsylvania State University College of Medicine, Hershey, Pennsylvania
- 3Consultant, Telz Stone, Israel
- 4Neural and Behavioral Sciences, Pennsylvania State University, Hershey, Pennsylvania
Correspondence: Jill P Smith, MD, Division of GI and Hepatology H-045, Department of Medicine, BMR C5800, Pennsylvania State University College of Medicine, 500 University Drive, Hershey, PA 17033.
Received 15 June 2006; Accepted 1 November 2006.
Abstract
OBJECTIVES:
Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair of tissues. 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 activity index (CDAI) score of 220–450 were enrolled in a study using 4.5 mg naltrexone/day. Infliximab was not allowed for a minimum of 8 wk prior to study initiation. Other therapy for Crohn's disease that was at a stable dose for 4 wk prior to enrollment was continued at the same doses. Patients completed the inflammatory bowel disease questionnaire (IBDQ) and the short-form (SF-36) quality of life surveys and CDAI scores were assessed pretreatment, every 4 wk on therapy and 4 wk after completion 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 decreased significantly (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 with baseline. No laboratory abnormalities were noted. The most common side effect was sleep disturbances, occurring in seven patients.
CONCLUSIONS:
LDN therapy appears effective and safe in subjects with active Crohn's disease. Further studies are needed to explore the use of this compound.
