Official Title
Effects of Low Dose Naltrexone in Fibromyalgia
Phase
N/ALead Sponsor
Stanford UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Fibromyalgia Persian Gulf SyndromeIntervention/Treatment
naltrexone ...Study Participants
53Low 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.
3-4.5mg Naltrexone once daily
Placebo pill once daily
LDN first, then placebo.
Placebo first, then LDN.
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.
| Event Type | Organ System | Event Term | Low Dose Naltrexone | Placebo - Sugar Pill |
|---|
Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable. Baseline pain calculated averaging daily pain scores over the 2 week baseline period. Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition. Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100.
Visual Analogue Scale for sleep quality, 0 to 100, where 0 = "did not sleep well at all" and 100 = "slept extremely well". Baseline sleep quality calculated by averaging daily scores over the 2 week baseline period. Placebo and LDN sleep quality scores calculated by averaging daily scores during the final 3 days of each condition. Values were converted to percent change in sleep quality: [(baseline sleep - end point sleep)/baseline sleep] x 100.
Visual Analogue Scale for fatigue, 0 to 100, where 0 = "no fatigue at all" and 100 = "severe fatigue". Baseline fatigue calculated averaging daily scores over the 2 week baseline period. Placebo and LDN fatigue scores calculated by averaging daily scores during the final 3 days of each condition. Values were converted to percent change in fatigue: [(baseline fatigue - end point fatigue)/baseline fatigue] x 100.
An algometer is used to apply pressure to 18 points across the body. Pressure is applied until the first sensation of pain in indicated. This pressure is recorded (as kg/cm2) and averaged for all 18 points to provide an overall score.
A thermode is placed on the palm, and temperature is increased until the first sensation of pain. That temperature is recorded in Degrees Celsius . The procedure is repeated 3 times and results are averaged into a single temperature recording.
