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Effects of Low Dose Naltrexone in Fibromyalgia
This study is ongoing, but not recruiting participants.
Study NCT00568555   Information provided by Stanford University
First Received: December 4, 2007   Last Updated: July 9, 2009   History of Changes

December 4, 2007
July 9, 2009
June 2007
June 2010   (final data collection date for primary outcome measure)
  • Fatigue
  • Pain
  • Sleep quality
Same as current
Complete list of historical versions of study NCT00568555 on ClinicalTrials.gov Archive Site
  • Mechanical Pain Sensitivity
  • Thermal Pain Sensitivity
Same as current
 
Effects of Low Dose Naltrexone in Fibromyalgia
Effects of Low Dose Naltrexone in Fibromyalgia

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.

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.

 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
  • Fibromyalgia
  • Persian Gulf Syndrome
Drug: Naltrexone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:Currently suffering from moderate to severe Fibromyalgia or symptoms of Gulf War Syndrome Age 18-65. Not taking any opioid analgesic Not pregnant or planning to become pregnant.

Exclusion Criteria:Any known allergy to naltrexone or naloxone. Actual or planned pregnancy.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00568555
Sean Mackey, Principal Investigator, Stanford University School of Medicine
SU-10232007-756, 8948
Stanford University
American Fibromyalgia Syndrome Association
Sub-Investigator: Jarred Younger Stanford University
Stanford University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP