Immune Effects of Low-dose Naltrexone in ME/CFS

NCT02965768 | Withdrawn

• 1 other identifier: F160525003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Durability of reduction in plasma inflammatory biomarkers

  Baseline; 12 weeks drug; 24 weeks drug

• Reduction in self-reported fatigue

  12 weeks drug

• Increase in physical function

  12 weeks drug

• Reduction in self-reported symptoms of (i) depression, (ii) anxiety

  12 weeks drug

Study Arms (2)

LDN arm

ACTIVE COMPARATOR

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

Drug: Naltrexone HCl

Placebo/LDN arm

OTHER

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.

Drug: Naltrexone HCl

Interventions

Naltrexone HCl DRUG

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

Also known as: Low-dose Naltrexone, LDN

LDN arm; Placebo/LDN arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• Blood draw contraindicated or otherwise not able to be performed
• High-sensitivity c-reactive protein (HS-CRP) ≥3 mg/L
• Erythrocyte sedimentation rate (ESR) \>60 mm/hr
• Positive rheumatoid factor
• Positive anti-nuclear antibody (ANA)
• Levels of thyroid stimulating hormone or free thyroxine outside UAB lab reference values
• Diagnosed rheumatological or auto-immune condition
• Clotting disorder
• Use of blood thinning medication
• Oral temperature \>100˚F at baseline
• Febrile illness or use of antibiotics in the 4 weeks before study commencement;
• Planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement
• Pregnant or planning on becoming pregnant within 6 months
• Regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen)
• Known allergy or adverse effects following naltrexone or naloxone administration

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related 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.

  PMID: 24526250 BACKGROUND

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jarred Younger, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind trial. An encrypted and password-protected database will contain (1) information about individual group assignment, and (2) blister pack codes (medication will be dispensed in blister packs by investigators based on these codes). An investigator not involved with data collection or participant interactions will randomly assign individuals to the treatment group and provide blister pack ID codes for each individual.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 17, 2016
• Study Start: January 1, 2016
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)