N/A
Completed N=31
Effects of Low Dose Naltrexone in Fibromyalgia
Fibromyalgia · Persian Gulf Syndrome
Source: ClinicalTrials.gov NCT00568555 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. — 28.8; 18.0 percentage change from baseline to final
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. |
28.8; 18.0 | — |
| SECONDARY Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. |
10.4; 9.2 | — |
| SECONDARY Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment. |
12.6; 7.8 | — |
| SECONDARY Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment. |
36.70; 28.26 | — |
| SECONDARY Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment. |
3.12; 3.45 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00568555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.