N/A N=31 Randomized Triple-blind Treatment

Effects of Low Dose Naltrexone in Fibromyalgia

Fibromyalgia · Persian Gulf Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00568555 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2015

Primary outcome: 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 percentage change from baseline to final

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Low Dose Naltrexone (Drug); Placebo - sugar pill (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jan 2010

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.