Effects of Low Dose Naltrexone in Fibromyalgia
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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: Low Dose Naltrexone Drug: Placebo - sugar pill |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Low Dose Naltrexone in Fibromyalgia |
- Pain [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]
- Sleep quality [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
- Fatigue [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]
- Mechanical Pain [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
- Thermal pain sensitivity [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
| Enrollment: | 53 |
| Study Start Date: | June 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Low Dose Naltrexone |
Drug: Low Dose Naltrexone
3-4.5mg Naltrexone once daily
|
| Placebo Comparator: Placebo - sugar pill |
Drug: Placebo - sugar pill
Placebo pill once daily
|
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.
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Sub-Investigator: | Jarred Younger | Stanford University |
More Information
No publications provided by Stanford University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sean Mackey, Associate Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00568555 History of Changes |
| Other Study ID Numbers: | SU-10232007-756, 8948 |
| Study First Received: | December 4, 2007 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Persian Gulf Syndrome Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Occupational Diseases |
Naltrexone Narcotic Antagonists Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013