LDN Therapy Improves Active Crohn's - Clinical Trial 2007

1. Am J Gastroenterol. 2007 Apr;102(4):820-8. Epub 2007 Jan 11.

Low-dose naltrexone therapy improves active Crohn's disease.

Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS.

Department of Medicine, Pennsylvania State University College of Medicine,
Hershey, Pennsylvania 17033, USA.

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.


PMID: 17222320 [PubMed - indexed for MEDLINE]