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| Descriptive Information Fields | |||||
| Brief Title † | Effects of Low Dose Naltrexone in Fibromyalgia | ||||
| Official Title † | Effects of Low Dose Naltrexone in Fibromyalgia | ||||
| Brief 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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Pain Fatigue Sleep quality |
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| Secondary Outcome Measure † | Mechanical Pain Sensitivity Thermal Pain Sensitivity |
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| Condition † | Fibromyalgia Persian Gulf Syndrome |
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| Intervention † | Drug: Naltrexone | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 60 | ||||
| Start Date † | June 2007 | ||||
| Completion Date | |||||
| Eligibility 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. |
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00568555 | ||||
| Organization ID | SU-10232007-756 | ||||
| Secondary IDs †† | 8948 | ||||
| Study Sponsor † | Stanford University | ||||
| Collaborators †† | American Fibromyalgia Syndrome Association | ||||
| Investigators † |
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| Information Provided By | Stanford University | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | December 4, 2007 | ||||
| Last Updated Date | October 3, 2008 | ||||
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