Low Dose Naltrexone (LDN) Immune Monitoring

Completed · Not applicable

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID: NCT02107014
Run by: University of Alabama at Birmingham
People needed: 9
Starts: 2014-03-01
Expected to finish: 2014-07-01
Last updated by the study team: 2017-04-11

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Stanford University School of Medicine — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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