Immune Effects of Low-dose Naltrexone in ME/CFS

Not Applicable

Withdrawn

• Conditions: Fatigue Syndrome, Chronic
• Interventions: Drug: Naltrexone HCl

• Registration Number: NCT02965768
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-17
• Status Verified: 2022-08
• Primary Completion: 2022-08-25
• Study Completion: 2022-08-25
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LDN arm	Naltrexone HCl	Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks
Placebo/LDN arm	Naltrexone HCl	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States