An open-labeled pilot prospective trial suggests a low-dose naltrexone (LDN), an opioid antagonist, improves healing in patients with active Crohn’s disease.
A team of scientists led by Dr. Jill Smith, a gastroenterologist, and Ian Zagon, a professor of neural and behavioral sciences, received federal funding last summer to initiate the phase 2 trial. 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.
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.
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. The results indicated 89 percent of patients with diagnosed Crohn’s disease showed an improvement after receiving a low dose of naltrexone for 12 weeks. In addition, 67 percent achieved remission of all symptoms. The results are detailed online this week in the American Journal of Gastroenterology. LDN therapy appears effective and safe in subjects with active Crohn’s disease. Further studies are needed to explore the use of this compound.