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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Dose Naltrexone
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Low Dose Naltrexone (LDN)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in IL-1α From Baseline.
Change in IL-1β From Baseline.
Change in IL-1Ra From Baseline.
Change in IL-2 From Baseline.
Change in IL-4 From Baseline.
Change in IL-5 From Baseline.
Change in IL-6 From Baseline.
Change in IL-7 From Baseline.
Change in IL-8 From Baseline.
Change in IL-9 From Baseline.
Change in IL-10 From Baseline.
Change in IL-12p40 From Baseline.
Change in IL-12p70 From Baseline.
Change in IL-13 From Baseline.
Change in IL-15 From Baseline.
Change in IL-17A From Baseline.
Change in IL-17F From Baseline.
Change in IL-18 From Baseline.
Change in IL-21 From Baseline.
Change in IL-23 From Baseline.
Change in IL-31 From Baseline.
Change in IL-27 From Baseline.
Change in LIF From Baseline.
Change in G-CSF From Baseline.
Change in GM-CSF From Baseline.
Change in MIP-1α From Baseline.
Change in SDF-1α From Baseline.
Change in IP-10 From Baseline.
Change in Eotaxin From Baseline.
Change in RANTES From Baseline.
Change in MIP-1β From Baseline.
Change in MCP-1 From Baseline.
Change in MCP-3 From Baseline.
Change in MIG From Baseline.
Change in TRAIL From Baseline.
Change in CD40L From Baseline.
Change in TGF-α From Baseline.
Change in TGF-β From Baseline.
Change in IFN-α From Baseline.
Change in IFN-β From Baseline.
Change in IFN-γ From Baseline.
Change in TNF-α From Baseline.
Change in TNF-β From Baseline.
Change in PIGF-1 From Baseline.
Change in SCF From Baseline.
Change in HGF From Baseline.
Change in VEGF-D From Baseline.
Change in VEGF From Baseline.
Change in NGF From Baseline.
Change in EGF From Baseline.
Change in FGF-β From Baseline.
Change in M-CSF From Baseline.
Change in BDNF From Baseline.
Change in ICAM-1 From Baseline.
Change in VCAM-1 From Baseline.
Change in ENA-78 From Baseline.
Change in PDGF-BB From Baseline.
Change in PAI-1 From Baseline.
Change in Leptin From Baseline.
Change in Resistin From Baseline.
Change in GROa From Baseline.
Change in FaSL From Baseline.
Change in IL-22 From Baseline.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2014
Last Updated
February 28, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02107014
Brief Title
Low Dose Naltrexone (LDN) Immune Monitoring
Acronym
LDN-IM
Official Title
Low Dose Naltrexone (LDN) Immune Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose Naltrexone (LDN)
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Low Dose Naltrexone
Other Intervention Name(s)
LDN, Naltrexone
Intervention Description
Naltrexone 4.5 mg p.o. nocte
Primary Outcome Measure Information:
Title
Change in IL-1α From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-1β From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-1Ra From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-2 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-4 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-5 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-6 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-7 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-8 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-9 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-10 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-12p40 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-12p70 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-13 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-15 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-17A From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-17F From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-18 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-21 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-23 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-31 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-27 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in LIF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in G-CSF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in GM-CSF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in MIP-1α From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in SDF-1α From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IP-10 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in Eotaxin From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in RANTES From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in MIP-1β From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in MCP-1 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in MCP-3 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in MIG From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in TRAIL From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in CD40L From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in TGF-α From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in TGF-β From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IFN-α From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IFN-β From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IFN-γ From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in TNF-α From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in TNF-β From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in PIGF-1 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in SCF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in HGF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in VEGF-D From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in VEGF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in NGF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in EGF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in FGF-β From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in M-CSF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in BDNF From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in ICAM-1 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in VCAM-1 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in ENA-78 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in PDGF-BB From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in PAI-1 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in Leptin From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in Resistin From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in GROa From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in FaSL From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in IL-22 From Baseline.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in Pain From Baseline.
Description
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.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Title
Change in Overall Fibromyalgia Symptoms From Baseline.
Description
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.
Time Frame
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarred Younger, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

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Low Dose Naltrexone (LDN) Immune Monitoring

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