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| Sponsors and Collaborators: |
Stanford University American Fibromyalgia Syndrome Association |
|---|---|
| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Effects of Low Dose Naltrexone in Fibromyalgia |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Jarred Younger | LDN_Younger@stanford.edu |
| 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 | |
| Sub-Investigator: | Jarred Younger | Stanford University |
More Information
| Responsible Party: | Stanford University School of Medicine ( Jarred Younger ) |
| Study ID Numbers: | SU-10232007-756, 8948 |
| Study First Received: | December 4, 2007 |
| Last Updated: | March 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00568555 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Fibromyalgia Myofascial Pain Syndromes Narcotic Antagonists Disorders of Environmental Origin Pain Narcotics Rheumatic Diseases |
Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Naltrexone Occupational Diseases Peripheral Nervous System Agents Persian Gulf Syndrome |
|
Disease Fibromyalgia Myofascial Pain Syndromes Physiological Effects of Drugs Narcotic Antagonists Nervous System Diseases Disorders of Environmental Origin Rheumatic Diseases Pharmacologic Actions Muscular Diseases Pathologic Processes |
Musculoskeletal Diseases Neuromuscular Diseases Sensory System Agents Therapeutic Uses Syndrome Naltrexone Occupational Diseases Peripheral Nervous System Agents Central Nervous System Agents Persian Gulf Syndrome |
