Pilot study shows withdrawal drug offers relief to Crohn's sufferers

University Park, Pa. -- A Penn State College of Medicine pilot study suggests a low dose of naltrexone, a drug used to ease symptoms of alcohol and drug addiction, also may bring relief to people with Crohn's disease, a chronic inflammatory disorder of the intestine that affects an estimated 500,000 Americans.

The study results were released online this week in an early edition of the American Journal of Gastroenterology.

A team of researchers led by gastroenterologist Jill P. Smith and Ian S. Zagon, distinguished professor of neural and behavioral sciences, at the College of Medicine and Penn State Milton S. Hershey Medical Center, received NIH funding last summer to initiate a phase 2 trial of low-dose naltrexone and Crohn's.

In the pilot study, patients with diagnosed Crohn’s disease were treated with a low dose of naltrexone and monitored for improvement of symptoms for 12 weeks. Quality of life surveys were given every four weeks for 16 weeks. The results, published this week, show that 89 percent of participants showed an improvement with therapy, while 67 percent achieved remission of symptoms. The only side effect to treatment was sleep disturbance in some patients.

Typical treatment for Crohn's involves using steroids or corticosteroids, which suppress the immune system and can have other toxic side effects. Treatment is often time-intensive and expensive as well.

"This is a novel approach to treating a common disease, and it's simple, it's safe and it costs far less than current standards of treatment," Smith said. "We don't yet know the exact mechanisms involved in how it works, but we're working on that as well."

In a related study, Smith and other College of Medicine researchers are studying the chemical and molecular mechanisms involved in suppression of inflammatory responses in the intestine when animals are treated with naltrexone.

Team members on the first study include Heather Stock, Sandra Bingaman and David Mauger, Department of Health Evaluation Sciences, Penn State College of Medicine.

Members of the second study team include Gail L. Matters and John F. Harms, Department of Biochemistry and Molecular Biology; Leo Fitzpatrick, Department of Surgery; and Anuj Parikh and Nicholas Nilo, Department of Medicine, Penn State College of Medicine.

The phase 2 study of naltrexone for Crohn's also is supported by funding by the Broad Medical Research Program.