Low Dose Naltrexone (LDN) Immune Monitoring

Fibromyalgia Clinical Trial

— LDN-IM  

Official title:

Low Dose Naltrexone (LDN) Immune Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02107014
• Other study ID #: 29911
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2014
• Last updated: April 7, 2014
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2014
• Source: Stanford University
• Contact: Jarred Younger, PhD
• Phone: 650-721-1988
• Email: youngerlab[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Fibromyalgia

Intervention

Drug:
• Low Dose Naltrexone

• Placebo

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average daily pain (0-100 Visual Analogue Scale) correlated with change in immune markers	Change in pain from placebo period to end of drug period correlated with change in immune markers from placebo to end of drug period	End of placebo compared to end of drug period. Total comparison period is 12 weeks.	No