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Low Dose Naltrexone (LDN) Immune Monitoring (LDN-IM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02107014
First Posted: April 8, 2014
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanford University
Information provided by (Responsible Party):
Jarred W. Younger, University of Alabama at Birmingham
  Purpose
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.

Condition Intervention
Fibromyalgia Drug: Low Dose Naltrexone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Low Dose Naltrexone (LDN) Immune Monitoring

Resource links provided by NLM:


Further study details as provided by Jarred W. Younger, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in IL-1α From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-1β From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-1Ra From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-2 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-4 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-5 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-6 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-7 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-8 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-9 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-10 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-12p40 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-12p70 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-13 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-15 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-17A From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-17F From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-18 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-21 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-23 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-31 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-27 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in LIF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in G-CSF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in GM-CSF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in MIP-1α From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in SDF-1α From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IP-10 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in Eotaxin From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in RANTES From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in MIP-1β From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in MCP-1 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in MCP-3 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in MIG From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in TRAIL From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in CD40L From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in TGF-α From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in TGF-β From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IFN-α From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IFN-β From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IFN-γ From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in TNF-α From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in TNF-β From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in PIGF-1 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in SCF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in HGF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in VEGF-D From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in VEGF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in NGF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in EGF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in FGF-β From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in M-CSF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in BDNF From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in ICAM-1 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in VCAM-1 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in ENA-78 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in PDGF-BB From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in PAI-1 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in Leptin From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in Resistin From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in GROa From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in FaSL From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in IL-22 From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
  • Change in Pain From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
    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.

  • Change in Overall Fibromyalgia Symptoms From Baseline. [ Time Frame: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. ]
    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.


Enrollment: 9
Study Start Date: March 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low Dose Naltrexone (LDN)
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
Naltrexone 4.5 mg p.o. nocte
Other Names:
  • LDN
  • Naltrexone

Detailed Description:

Eligible women with Fibromyalgia (FM) will be enrolled into a 10-week drug trial. During the first two weeks, a baseline phase will be used to collect data on immune function and symptoms. LDN will be administered for 8 weeks. Although there is no placebo arm built-in, participants will be advised that they may receive a placebo during the trial. Participants will provide twice daily symptom reports using an android tablet device and Dooblo SurveyToGo survey software. Participants will also provide a blood sample twice every week for the duration of the study. Plasma inflammatory markers will be tested using a luminex based 63-plex inflammatory assay panel.

The primary aim of the study is to test if 8 weeks of LDN administration is associated with a reduction in pro-inflammatory markers in plasma in women with FM.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107014


Locations
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
University of Alabama at Birmingham
Stanford University
Investigators
Principal Investigator: Jarred Younger, PhD University of Alabama at Birmingham
  More Information

Responsible Party: Jarred W. Younger, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02107014     History of Changes
Other Study ID Numbers: 29911
First Submitted: April 1, 2014
First Posted: April 8, 2014
Results First Submitted: December 28, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents