Immune Effects of Low-dose Naltrexone in ME/CFS

Fatigue Syndrome, Chronic Clinical Trial

Official title:

The Immune Effects of Low-dose Naltrexone in People With Myalgic Encephalopathy/Chronic Fatigue Syndrome (ME/CFS)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02965768
• Other study ID #: F160525003
• Status: Withdrawn
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 25, 2022

Study information

• Verified date: August 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Drug:
• Naltrexone HCl
4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose);

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in plasma inflammatory biomarkers	Levels of plasma IL-1B, TNFa, IL6, IL12, and IL17 will be tested as the primary biomarkers of interest.	Four-week baseline; 12 weeks drug
Secondary	Durability of reduction in plasma inflammatory biomarkers	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.	Baseline; 12 weeks drug; 24 weeks drug
Secondary	Reduction in self-reported fatigue	Fatigue will be reported daily on a hand-held computer device.	12 weeks drug
Secondary	Increase in physical function	Physical function will be reported weekly on a Patient-Specific Functional Scale.	12 weeks drug
Secondary	Reduction in self-reported symptoms of (i) depression, (ii) anxiety	Symptoms of depression and anxiety will be reported weekly on a Hospital Anxiety and Depression Scale.	12 weeks drug