drugset / Trial / NCT00568555

Effects of Low Dose Naltrexone in Fibromyalgia

NCT00568555 ↗

RandomizedCrossoverTriple-blindTreatment

Summary

Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems. In this study, we will administer both LDN and placebo to a small group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom Illnesses, to assess the drug's efficacy in treating the condition.

Timeline

Start
2007-06
Primary completion
2010-01
Completion
2010-01

Outcome

Met primary endpoint

paper significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). PMID 23359310 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 3 mg Oral
Subject Naltrexone Small molecule 4.5 mg Oral