Immune Effects of Low-dose Naltrexone in ME/CFS

NCT ID: NCT02965768

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2022-08-25

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.

Conditions

Fatigue Syndrome, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

LDN arm

Naltrexone HCl 4.5mg (standard-dose) or 3.0mg (optional-dose) x24 weeks

Group Type: ACTIVE_COMPARATOR

Naltrexone HCl

Intervention Type: DRUG

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

Placebo/LDN arm

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.

Group Type: OTHER

Naltrexone HCl

Intervention Type: DRUG

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

Interventions

Naltrexone HCl

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

Intervention Type: DRUG

Other Intervention Names

Low-dose Naltrexone; LDN

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jarred Younger

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jarred Younger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24526250 (View on PubMed)

Other Identifiers

F160525003

Identifier Type: -

Identifier Source: org_study_id