Low Dose Naltrexone (LDN) Immune Monitoring

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University; University of Alabama at Birmingham
• Collaborator: Stanford University
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Females age 18-65

• Meets criteria for 1990 ACR criteria for fibromyalgia

• Able to receive venous blood draw twice a week for 16 weeks

• Sufficient symptom variability during baseline report

• Patient completes daily report during 2 week baseline period at least 80% completion rate.

Exclusion Criteria:

• Opioid use

• Significant psychological comorbidity that in the discretion of the investigator compromises study integrity

• Location prohibits travel to Stanford

• Blood or clotting disorder

• Rheumatologic or autoimmune disease

• Acute infection

• Baseline blood ESR >60, CRP greater than 3.0mg/L, positive rheumatoid factor, or positive ANA

• Use of blood thinning medication

• Pregnant or currently planning to become pregnant

• Current use of aspirin, ibuprofen, naproxen, or other confounding-anti-inflammatory medication as part of regular medication regimen.

• Known allergy to Naltrexone or Naloxone

• Currently participating in another treatment-based research study

• Self-reported inability to refrain from alcohol for the duration of the study period