Immune Effects of Low-dose Naltrexone in ME/CFS
Study Details
Study Description
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 |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| 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:
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| Other: 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:
|
Outcome Measures
Primary Outcome Measures
- Reduction in plasma inflammatory biomarkers [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
- Durability of reduction in plasma inflammatory biomarkers [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 [12 weeks drug]
Fatigue will be reported daily on a hand-held computer device.
- Increase in physical function [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 [12 weeks drug]
Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Meet the 1994 Case Definition criteria for CFS (assessed through semi-structured interview and the DePaul University Fatigue Questionnaire):
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Criteria:
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Severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue;
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Fatigue interferes with daily activities and work;
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Reports ≥4 symptoms that started with or after the fatigue, from:
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Post-exertion malaise >24 hours
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Unrefreshing sleep
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Short-term memory or concentration impairment
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Muscle pain
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Joint pain without swelling or redness
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Headaches of a new type/pattern/severity
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Lymph node tenderness
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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:
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Blood draw contraindicated or otherwise not able to be performed
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High-sensitivity c-reactive protein (HS-CRP) ≥3 mg/L
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Erythrocyte sedimentation rate (ESR) >60 mm/hr
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Positive rheumatoid factor
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Positive anti-nuclear antibody (ANA)
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Levels of thyroid stimulating hormone or free thyroxine outside UAB lab reference values
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Diagnosed rheumatological or auto-immune condition
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Clotting disorder
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Use of blood thinning medication
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Oral temperature >100˚F at baseline
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Febrile illness or use of antibiotics in the 4 weeks before study commencement;
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Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement
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Pregnant or planning on becoming pregnant within 6 months
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Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen)
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Known allergy or adverse effects following naltrexone or naloxone administration
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Opioid use (self-reported or positive on urine test)
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Significant psychological comorbidity that in the discretion of the investigator compromises study integrity and/or a baseline HADS depression subscale score of ≥16
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Current litigation or worker's compensation claim
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Current participation in another treatment trial
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- F160525003