A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone on Quality of Life as Measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI54)

Immunomodulatory and immunosuppressive therapies are known to modify the course of the disease. Interferon beta-1a, interferon beta-1b and glatiramer acetate are immunomodulators whereas mitoxantrone and natalizumab are immunosuppressants

The disease modifying therapies decrease the frequency of relapses and are associated with improved neurological outcomes relative to placebo. However, these medications are only partially effective, are expensive, require either frequent self injections or intravenous infusion and have significant side effects. None are proven in the progressive forms of MS and none of alleviate the symptoms associated with MS.

Endogenous Opioid peptides and Naltrexone:

Low dose naltrexone (LDN) is proposed to adjust the level of endorphins in the body thereby enhancing immune function and is anecdotally beneficial in MS. LDN is inexpensive, easily administered (one capsule a day at bedtime), and virtually has no serious side effect (during the first weeks of LDN use, some patients complain of some difficulty sleeping, that rarely persists after the first week). Although use of LDN is popular within the MS community efficacy is not proven because clinical trials have not been performed.

Naltrexone, is an opioid antagonist approved by the FDA in 1984 in a 50mg dose for the treatment of opioid and alcohol abuse. By blocking opioid receptors, naltrexone also blocks reception of the endogenous opioid peptides: beta-endorphin, metenkephalin and dynorphin. Virtually every cell of the immune system has receptor for these mediators. These peptides regulate a wide range of biological activities, including immune responses through interaction with G-protein coupled transmembrane opioid receptors.