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Treatment Studies

Low Dose Naltrexone for the Treatment of Fibromyalgia

Evaluate the effectiveness of low dose naltrexone (LDN) for relieving the pain and associated symptoms of fibromyalgia.

Study Drug: Low dose naltrexone compounded into a small capsule

Investigators: Jarred Younger, Ph.D., and Sean Mackey, M.D., Ph.D., at Stanford University

Funding Source: The American Fibromyalgia Syndrome Association (AFSA)

FDA Status: Naltrexone is an FDA-approved drug that is no longer on patent. It is commercially available in tablets of 50 mg, but at this dose it blocks the pain relieving action of opioids. At a significantly lower dose (less than 5 mg) the drug is suspected of producing pain relief, but this requires special compounding.

Basic Info: Animal studies indicate that low dose naltrexone (LDN) can treat neuropathic pain (e.g., pain caused by nerve injury). Also, small treatment trials involving LDN are now under way to determine its ability to treat various types of chronic pain. This trial represents the first scientifically controlled study to test LDN in patients with fibromyalgia. While the exact mechanism of LDN to treat chronic pain is not fully understood, it may work by calming down the glial cells in the central nervous system. When glial cells are activated, they produce substances that cause pain and sleep disruption. When they are in a calm state, these immune system cells are believed to aid the body’s ability to fight pain.

Recruiting for Trial: Forty (40) fibromyalgia patients will undergo a placebo-controlled cross-over trial. Your participation in the study will take a total of four months, although you will not be taking medication the entire time. For a few weeks, you will track your daily symptoms on an easy-to-use handheld computer. Following that baseline period, you will start taking either LDN or placebo for 6 weeks, and then switch to the other compound for 6 weeks. A 2-week waiting period will separate the two trial phases. During your participation in the study, you must travel to the Stanford Center for brief (about 45-minute) visits every two weeks. These visits are to monitor your progress, and make sure that you are tolerating the drug well.

There are no costs to you for any of the tests or exams, and you will be compensated for your participation. However, you must provide your own transportation to and from the Stanford Medical Center in Palo Alto, CA. Participants will be required to visit the Stanford Center up to ten times during the four-month study, so you should live within 100 miles of Stanford.

Study Criteria (key requirements):

Study Location:

Stanford Systems Neuroscience and Pain Lab (SNAPL)
780 Welch Rd
Palo Alto, CA 94304

To learn more about the study, please visit the project homepage at www.snapl.stanford.edu/ldn/

The Fibromyalgia Network is not in any way associated with any clinical trials, pharmaceutical companies, device manufacturers, or government agencies. As a self-help organization, we accept no sponsorship, advertisements, or government funds. The information on these pages is provided as a public service.

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