Fatigue Syndrome, Chronic
Conditions
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.
Interventions
DRUGNaltrexone HCl
4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose);
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed