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Immune Effects of Low-dose Naltrexone in ME/CFS

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ClinicalTrials.gov Identifier: NCT02965768
Recruitment Status : Suspended (Temporarily suspended to focus on other projects. At suspension, no participants were determined eligible and none started the protocol.)
First Posted : November 17, 2016
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jarred Younger, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE November 14, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date September 5, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
Reduction in plasma inflammatory biomarkers [ Time Frame: Four-week baseline; 12 weeks drug ]
Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02965768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • Durability of reduction in plasma inflammatory biomarkers [ Time Frame: Baseline; 12 weeks drug; 24 weeks drug ]
    Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest. 24 weeks vs 12 weeks drug.
  • Reduction in self-reported fatigue [ Time Frame: 12 weeks drug ]
    Fatigue will be reported daily on a hand-held computer device.
  • Increase in physical function [ Time Frame: 12 weeks drug ]
    Physical function will be reported weekly on a Patient-Specific Functional Scale.
  • Reduction in self-reported symptoms of (i) depression, (ii) anxiety [ Time Frame: 12 weeks drug ]
    Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Effects of Low-dose Naltrexone in ME/CFS
Official Title  ICMJE The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)
Brief Summary The main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (CFS). In part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with CFS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind trial. An encrypted and password-protected database will contain (1) information about individual group assignment, and (2) blister pack codes (medication will be dispensed in blister packs by investigators based on these codes). An investigator not involved with data collection or participant interactions will randomly assign individuals to the treatment group and provide blister pack ID codes for each individual.
Primary Purpose: Other
Condition  ICMJE Fatigue Syndrome, Chronic
Intervention  ICMJE Drug: Naltrexone HCl
4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose);
Other Names:
  • Low-dose Naltrexone
  • LDN
Study Arms  ICMJE
  • Active Comparator: LDN arm
    Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks
    Intervention: Drug: Naltrexone HCl
  • Placebo/LDN arm

    Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) Placebo

    Individuals will be switched between drugs as per approved schedule during the 24 weeks.

    Intervention: Drug: Naltrexone HCl
Publications * Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 16, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Meet the 1994 Case Definition criteria for CFS (assessed through semi-structured interview and the DePaul University Fatigue Questionnaire):

  • Criteria:

    • Severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue;
    • Fatigue interferes with daily activities and work;
    • Reports ≥4 symptoms that started with or after the fatigue, from:
  • Post-exertion malaise >24 hours
  • Unrefreshing sleep
  • Short-term memory or concentration impairment
  • Muscle pain
  • Joint pain without swelling or redness
  • Headaches of a new type/pattern/severity
  • Lymph node tenderness
  • Frequent or recurring sore throat 3. CFS symptoms for ≥12 months 4. Participant completes daily self-report during the 4-week baseline period; 5. Able to attend UAB on all scheduled appointments

Exclusion Criteria:

  1. Blood draw contraindicated or otherwise not able to be performed
  2. High-sensitivity c-reactive protein (HS-CRP) ≥3 mg/L
  3. Erythrocyte sedimentation rate (ESR) >60 mm/hr
  4. Positive rheumatoid factor
  5. Positive anti-nuclear antibody (ANA)
  6. Levels of thyroid stimulating hormone or free thyroxine outside UAB lab reference values
  7. Diagnosed rheumatological or auto-immune condition
  8. Clotting disorder
  9. Use of blood thinning medication
  10. Oral temperature >100˚F at baseline
  11. Febrile illness or use of antibiotics in the 4 weeks before study commencement;
  12. Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement
  13. Pregnant or planning on becoming pregnant within 6 months
  14. Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen)
  15. Known allergy or adverse effects following naltrexone or naloxone administration
  16. Opioid use (self-reported or positive on urine test)
  17. Significant psychological comorbidity that in the discretion of the investigator compromises study integrity and/or a baseline HADS depression subscale score of ≥16
  18. Current litigation or worker's compensation claim
  19. Current participation in another treatment trial
  20. Vaccinated in the 4 weeks before study commencement (vaccination during the study period is allowed as long as the drug is administered at least 4 weeks prior to a study blood draw).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02965768
Other Study ID Numbers  ICMJE F160525003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jarred Younger, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jarred Younger, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP