Low-Dose Naltrexone Therapy Improves Active Crohn’s Disease

Low-Dose Naltrexone Therapy Improves Active Crohn’s Disease
Jill P. Smith, M.D.,1 Heather Stock, M.D.,1 Sandra Bingaman, R.N.,1 David Mauger, Ph.D.,2
Moshe 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 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.
(Am J Gastroenterol 2007;102:820–828)