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Low Dose Naltrexone Update

January 2008—We have received a number of inquiries about the use of low dose naltrexone (LDN) as a treatment for multiple sclerosis.  There are currently no published data from controlled clinical trials to support the use of naltrexone in MS.  Further study is needed to determine if this is a safe and effective treatment for people with MS.

Naltrexone is an opioid antagonist that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of addictions to opioids and alcohol.  At significantly lower doses, it has been prescribed as a treatment for a variety of diseases, including various types of cancers, HIV/AIDS, Parkinson’s disease, Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), emphysema, as well as MS and other autoimmune diseases. 

Although the findings from a recent open-label, pilot study of LDN in Crohn’s disease have led to funding by NIH for a Phase II clinical trial in those patients, no data have yet been published from that pilot study in a peer-reviewed journal.  To date, there have been no published studies of LDN in other diseases. We look forward to seeing published results from the clinical trial of LDN in Crohn’s disease and hope that a similar trial will eventually be conducted in MS.  As stated on the National MS Society Web site, the Society is open to considering any high quality and relevant research protocol.  Any agent that has the potential to safely and effectively treat MS is of interest to the Society. 

As an initial step, the Society has funded a pilot study by Ian Zagon, PhD, from the College of Medicine at Pennsylvania State University, looking at the effects of both low- and high-dose naltrexone in mice with the MS-like disease, EAE. Based on earlier findings that opioids (which occur naturally on cells in the nervous system) may regulate immunity, wound healing, and cell renewal, Zagon and his colleagues are looking to see if mice treated with naltrexone demonstrate any changes in their MS-like symptoms or underlying disease activity.

In addition, several studies in people with MS have begun:

  • A pilot study at several northern Italian hospitals, under the direction of Dr. Maira Gironi, began enrolling patients for a pilot of LDN during the first week of December. 2007. The six-month trial is expected to be completed by early summer, 2008.

  • The MindBrain Consortium and the Department of Psychiatry of Summa Hospital System of Akron, Ohio—together with the Oak Clinic for the Treatment of Multiple Sclerosis—are conducting a 16-week, double-blind, randomized, placebo-controlled, crossover-design analysis of 36 patients with either progressive or relapsing-remitting MS. The study, under the direction of Dr. David Pincus, is examining symptom severity as well as any changes in quality of life, sleep patterns, and affective (emotional) states. Results are expected in the summer of 2008.

  • Patient advocates with MS have funded a 17-week, double-blind, randomized, placebo-controlled, crossover-design study at the University of California at San Francisco, under the direction of Dr. Bruce Cree. This trial, which will involve 80 people with MS, is scheduled to begin in the spring of 2008.

Research and Clinical Programs Department
in collaboration with
Allen Bowling , MD, PhD, Rocky Mountain MS Center

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