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Effects of Low Dose Naltrexone in Fibromyalgia

This study is currently recruiting participants.
Verified by Stanford University, April 2008

 
Sponsored by: Stanford University
 
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00568555
  Purpose

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.


Condition Intervention
Fibromyalgia
Persian Gulf Syndrome
 		 Drug: Naltrexone
 

MedlinePlus related topics:   Fibromyalgia   

ChemIDplus related topics:   Naltrexone    Naltrexone hydrochloride   

U.S. FDA Resources

 
Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
 
Official Title:   Effects of Low Dose Naltrexone in Fibromyalgia

 
Further study details as provided by Stanford University:

 
Primary Outcome Measures:
  • Pain
     
  • Fatigue
     
  • Sleep quality
     

Secondary Outcome Measures:
  • Mechanical Pain Sensitivity
     
  • Thermal Pain Sensitivity
     

 
Estimated Enrollment:   60
Study Start Date:   June 2007

Detailed Description:

This study will be a placebo-controlled, single-blind, pre-post drug trial. 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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
 

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.

  Contacts and Locations

 
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568555

Locations
 
 
United States, California
  Stanford University School of Medicine       Recruiting
        Stanford, California, United States, 94305
        Contact: Jarred Younger         LDN_Younger@stanford.edu    
        Principal Investigator: Sean Mackey            
        Sub-Investigator: Jarred Younger            

Sponsors and Collaborators
 
 
Stanford University

Investigators
 
 
Principal Investigator:     Sean Mackey     Stanford University    
  More Information

 
Study ID Numbers:   SU-10232007-756, 8948
First Received:   December 4, 2007
Last Updated:   April 4, 2008
ClinicalTrials.gov Identifier:   NCT00568555
Health Authority:   USA:Office of Human Research Protection

 
Study placed in the following topic categories:
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Naltrexone
 
Disorders of Environmental Origin
Occupational Diseases
Pain
Rheumatic Diseases
Persian Gulf Syndrome

 
Additional relevant MeSH terms:
Persian Gulf Syndrome
Pathologic Processes
Disease
Sensory System Agents
Therapeutic Uses
Syndrome
 
Physiological Effects of Drugs
Narcotic Antagonists
Nervous System Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 13, 2008