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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 : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Jarred W. Younger, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fatigue Syndrome, Chronic Drug: Naltrexone HCl Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)
Study Start Date : January 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LDN arm
Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks
 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
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.

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Reduction in self-reported fatigue [ Time Frame: 12 weeks drug ]
    Fatigue will be reported daily on a hand-held computer device.

  3. Increase in physical function [ Time Frame: 12 weeks drug ]
    Physical function will be reported weekly on a Patient-Specific Functional Scale.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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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): NCT02965768


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jarred Younger, PhD University of Alabama at Birmingham
More Information
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Publications:

Responsible Party: Jarred W. Younger, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02965768     History of Changes
Other Study ID Numbers: F160525003
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
 Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents