Naltrexone

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Use of naltrexone reduces inflammation in Crohn's patients

Hershey, Pa. -- Naltrexone reduced inflammation in Crohn's patients in a research study at Penn State College of Medicine.
Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract causing abdominal pain, diarrhea, gastrointestinal bleeding and weight loss. Treatments for Crohn's disease are designed to reduce the inflammation but may be associated with rare but serious side effects, including infections and lymphoma. Research suggests that endorphins and enkephalins, part of the opioid system, have a role in the development or continuation of inflammation.
Naltrexone is a drug used to help recovering alcoholics and drug users stay clean. It inhibits the body's opioid system that regulates pain and is involved in cell growth, repair and inflammation. Naltrexone binds to a protein receptor that blocks the effects of opioids, including the body's own enkephalins and endorphins, substances that reduce pain and produce a feeling of wellbeing.
"Although the cause of Crohn's disease is unknown, research suggests it involves a complex interplay of environmental, genetic, microbial, immune and nonimmune factors," said Dr. Jill P. Smith, professor of medicine. "We hypothesize that the opioid system is involved in inflammatory bowel disease and that interfering with an opioid receptor will lead to the reversal of the inflammation."
Researchers studied 40 patients with active Crohn's disease. Patients received either naltrexone or a placebo for 12 weeks. All patients then continued on naltrexone for an additional 12 weeks. This was a double-blind study with neither the patient or healthcare provider knowing which treatment was being received.
Eighty-eight percent of those treated with naltrexone had at least a 70-point decline in Crohn's Disease Activity Index scores compared to 40 percent of placebo-treated patients. CDAI is a point system used to quantify symptoms in Crohn's patients. Researchers noted no statistical difference at four or eight weeks of treatment, suggesting a response requires at least 12 weeks of treatment. Results were published in the journal Digestive Diseases and Sciences.
Gastrointestinal inflammation was evaluated by appearance of the intestine on colonoscopy and scores from biopsy specimens. After 12 weeks, researchers noted no change in those taking a placebo. However, 78 percent of those on naltrexone experienced healing in the lining of the intestine.
For those patients who received a placebo for 12 weeks and then were placed on naltrexone for the following 12 weeks, 70 percent experienced at least a 70-point decline in the CDAI score and healing of the colon as seen on colonoscopy. Patients who continued use of naltrexone for an additional 12 weeks (24 total weeks) had a further 75-point decline in CDAI scores, leading to remission (score of less than 150) in 50 percent of the patients.
"We report that naltrexone improves clinical and inflammatory activity of subjects with moderate to severe Crohn's disease compared to placebo-treated controls," Smith said.
The researchers are planning clinical trials to look at use of naltrexone in children with Crohn's disease and have secured orphan drug status from the Food and Drug Administration for the use of naltrexone in children with Crohn's disease. Smith and Zagon hold a patent for the use of naltrexone in inflammatory bowel disease -- Crohn's disease and ulcerative colitis.
The National Institutes of Health's Broad Medical Research Program funded this project.
Other researchers on the project are Ian Zagon, Ph.D., Department of Neural and Behavioral Sciences; Sandra I. Bingaman, R.N., Aparna Mukherjee, M.D., and Christopher O. McGovern, B.S., Department of Medicine; Francesco Ruggiero, M.D., Department of Pathology; and David Mauger, Ph.D., Department of Public Health Sciences.

2011

http://live.psu.edu/story/53494#rss30
 
I've been on low dose naltrexone treatment for Crohns since November of 2007. It has been a veritable life saver. The only side effect I've ever experienced was the occasional vivid dream. Regretably, those have since ended. I've undergone numerous bloodtests, etc., since starting to see if any other issues might arise from my treatment, and to date, none has. In November of 2010 the doctors did a very thorough scope, and the only sign of crohns was at the microscopic level... meaning that LDN does not cure crohns, but can keep it in check. My results have been so good, my GI has placed another 4 patients on LDN. All, like myself, are doing marvelously.
 
Correct me if I am wrong, but this is yet to be FDA approved as a treatment for Crohn's disease, right? I assume this is the reason it is not a traditionally used treatment option.
 
Correct, it's not FDA approved specifically for Crohn's. The drug is old and the patents have expired so there's no money in it for pharmaceutical companies. It could very well be a fantastic treatment but there likely won't be much done with it.
 
Apparently the practice is referred to as 'off patent' prescribing (could be wrong here, but I've been wrong on so many things in life, what is one more?). Naltrexone originally was approved for treating opiate and alcohol dependancy. So, in theory, that means doctors should be able to look at it's decades old pedigree/history in treating people with those issues (at substantially higher doses) and make a judgement call to try it in lower doses for those with Crohns. I have no information as to how long patients battling alcohol or opiate addictions were kept on Naltrexone. I do know that November will be 4 years for me at 4.5 mg, and I haven't started sprouting extra limbs or what not.

And, on another thread, there is info straight from Dr Jill Smith that Naltrexone can be used in conjunction with more traditional meds... which means that myself and a few others of us on here who ASSumed it couldn't be were wrong... (which points out again the hazards of taking well meant anecdotal info from well meaning amatuers like us all that seriously... but, hey, even the experts will change their opinion from one day to the next.)
 
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