Low Dose Naltrexone (LDN) Immune Monitoring



Status:Completed
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - 65
Updated:4/2/2016
Start Date:March 2014
End Date:June 2015
Contact:Jarred Younger, PhD
Email:youngerlab@stanford.edu
Phone:650-721-1988

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
Stanford University School of Medicine
Palo Alto, California 94304
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Palo Alto, CA
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