Low Dose Naltrexone (LDN) Immune Monitoring

NCT02107014 | Completed Results

• 1 other identifier: 29911
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (65)

• Change in IL-1α From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-1β From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-1Ra From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-2 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-4 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-5 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-6 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-7 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-8 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-9 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-10 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-12p40 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-12p70 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-13 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-15 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-17A From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-17F From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-18 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-21 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-23 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-31 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-27 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in LIF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in G-CSF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in GM-CSF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in MIP-1α From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in SDF-1α From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IP-10 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in Eotaxin From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in RANTES From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in MIP-1β From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in MCP-1 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in MCP-3 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in MIG From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in TRAIL From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in CD40L From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in TGF-α From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in TGF-β From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IFN-α From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IFN-β From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IFN-γ From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in TNF-α From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in TNF-β From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in PIGF-1 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in SCF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in HGF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in VEGF-D From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in VEGF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in NGF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in EGF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in FGF-β From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in M-CSF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in BDNF From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in ICAM-1 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in VCAM-1 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in ENA-78 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in PDGF-BB From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in PAI-1 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in Leptin From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in Resistin From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in GROa From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in FaSL From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in IL-22 From Baseline.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in Pain From Baseline.

  Visual analog scale (0-100) anchored at "no pain" at 0 and "worst possible pain" at 100. Improvement in pain would be indicated by a decrease in the score.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

• Change in Overall Fibromyalgia Symptoms From Baseline.

  Visual analog scale (0-100) anchored at "no symptoms" at 0 and "worst possible symptoms" at 100. Improvement in overall fibromyalgia symptoms would be indicated by a decrease in the score.

  Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

Study Arms (1)

Low Dose Naltrexone (LDN)

OTHER

Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.

Drug: Low Dose Naltrexone

Interventions

Low Dose Naltrexone DRUG

Naltrexone 4.5 mg p.o. nocte

Also known as: LDN, Naltrexone

Low Dose Naltrexone (LDN)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

No placebo control drug used - participants were only advised that placebo may be used during the trial.

Results Point of Contact

• Title: Dr. Jarred Younger
• Organization: University of Alabama at Birmingham

younger@uab.edu

2059755821

Study Officials

• Jarred Younger, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Locations

US (1)