Immune Effects of Low-dose Naltrexone in ME/CFS
| Status: | Suspended |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/21/2018 |
| Start Date: | January 2016 |
| End Date: | August 2019 |
The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)
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.
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.
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).
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