Immune Effects of Low-dose Naltrexone in ME/CFS

• Status: Suspended
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Naltrexone

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).