NCT00568555

Effects of Low Dose Naltrexone in Fibromyalgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be a placebo-controlled, double-blind, cross-over drug tria. Patients with Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain Management Center and the surrounding community. Participation in the study will cover 22 weeks. Participants will attend a laboratory session 12 times for progress checkups, and will complete daily measures of symptoms.

Conditions

• Fibromyalgia
• Persian Gulf Syndrome

Interventions

Type	Name	Description
DRUG	Low Dose Naltrexone	3-4.5mg Naltrexone once daily
DRUG	Placebo - sugar pill	Placebo pill once daily

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-12-06
• Last updated: 2015-10-21
• Results posted: 2015-10-21

Locations

1 site across 1 country: United States